System and method for filtering crude samples for nucleic acid amplification

Abstract

A filter tube assembly is provided. In one embodiment, the filter tube assembly comprises a filter, a dispensing cap, and a tube body. The filter tube assembly can be used to filter a buffer containing a sample as preparation for use in a molecular assay. The filter tube assembly can dispense a volume of liquid for the molecular assay by compressing the tube body of the filter tube assembly two or fewer times.

Description

[Technical Field]

[0001] [Cross-references to related applications] This application claims the benefits of U.S. Provisional Patent Application No. 63 / 495,271, filed on April 10, 2023, and U.S. Provisional Patent Application No. 63 / 570,750, filed on March 27, 2024. These prior applications are incorporated in their entirety by reference herein.

[0002] [Technical field] The systems and methods disclosed herein relate to the collection, processing, and testing of biological samples. More specifically, the systems, apparatus, and methods disclosed herein relate to test kits for preparing samples for use in molecular assays.

[0003] Molecular assays can be used in medical diagnosis. For example, molecular assays can be used to test for the presence of markers indicating a particular disease and / or condition.

[0004] Nucleic acid amplification is an exemplary molecular assay. Nucleic acid amplification is important in many fields, including testing in medicine, biomedicine, environmental science, veterinary medicine, and food safety. Exemplary methods of nucleic acid amplification include polymerase chain reaction (PCR) amplification, isothermal amplification, and / or archaeal polymerase amplification (APA).

[0005] Nucleic acid amplification can generate multiple copies of the target gene sequence in the test solution. A specific marker may be designed to link to the target sequence as part of a test assay. Once bound (linked), the marker may provide a detectable signal (e.g., an optical signal) from the test solution. Changes in the optical signal may include changes in the color, opacity, bioluminescence, and / or fluorescence of the test solution. In the case of a fluorescent marker beacon, each marker molecule may be configured with a fluorescent quencher immediately adjacent to a fluorescent atom or atomic sequence. This marker molecule may be configured such that the quencher and fluorophores separate when selectively bound to the target nucleic acid sequence, and the fluorescent signal can be detected by the action of the fluorophores. In such a configuration, the fluorescence intensity of the target solution indicates the relative amount of the target genetic material in the test solution. This signal can then be used to form the basis for a diagnostic test to determine the presence or relative amount of the target substance or analyte in the sample under test. [Overview of the project]

[0006] Each of the apparatus, systems, and methods of this disclosure possesses several innovative features, none of which alone constitute the desirable attributes. Without limiting the scope of this disclosure, more prominent features of the invention will be briefly described.

[0007] In one embodiment, a filter tube assembly is provided for preparing a sample-containing fluid for use in a molecular assay. The filter tube assembly may comprise a dispense cap having a channel and an opening, a filter positioned within the dispense cap, and a tube body having an open end and a closed end. The tube body is configured to hold the sample-containing fluid, and the dispense cap is configured to be fixed to the open end of the tube body. At least a portion of the tube body is made of a flexible material, which is configured to force one or more continuous streams of the sample-containing fluid through the filter, the channel, and the opening when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed. The dispense cap may be configured to propel about 2.5 mL to about 3.0 mL of filtered sample-containing fluid through the opening during two or fewer compressions of the flexible material. The filtered sample-containing fluid can be propelled through the opening as a continuous stream.

[0008] The filter tube assembly may be configured to propel a continuous flow of at least about 1 mL of filtered sample-containing fluid through the opening during a single compression of the tube. The flow path may have a transition region positioned near the filter, which may be configured to reduce the back pressure on the filter during compression of the flexible material. The diameter of the filter may be about 1.2 to about 1.6 times the diameter of the transition region. The diameter of the transition region may be about 8 mm to about 12 mm. The filter tube assembly may further include a retaining ring configured to secure the filter to the dispense cap. The retaining ring may have a groove configured to fit into a ridge on the inner surface of the dispense cap. In some other embodiments, the filter may be a cup filter having a wall configured to secure the filter to the dispense cap. The hardness of the material of the dispense cap may be greater than the hardness of the material of the tube body. The Young's modulus of the material of the dispense cap may be at least twice that of the Young's modulus of the material of the tube body. The Young's modulus of the material of the dispense cap may be at least about 800 MPa. The Young's modulus of the material of the tube body may be about 200 to about 300 MPa. The dispense cap may include high-density polyethylene (HDPE) or polypropylene. The material of the tube body may include low-density polyethylene (LDPE) or linear low-density polyethylene (LLDPE). The dispense cap may include a tethering ring configured to engage with the outside of the tube body. The filter tube assembly may further include a travel cap configured to be fixed to the open end of the tube body. The travel cap may include a collar configured to produce a plug seal that prevents fluid leakage from the internal volume of the tube body when the travel cap is fixed to the open end of the tube body. The travel cap may include a threaded portion configured to engage with the threaded portion of the tube body. The dispense cap may have a threaded portion configured to engage with the threaded portion of the tube body.The tube body may be at least partially transparent to visible light. The thickness of at least a portion of the wall of the tube body may be about 0.20 mm to about 1 mm. The filter may include a plurality of openings having a diameter of about 1 μm to about 250 μm. The filter may include polyethylene, glass fiber, polypropylene, or polytetrafluoroethylene. The tube body may have an internal volume of about 3 mL to about 5 mL. The tube body may be configured to hold about 2.5 mL to about 3.5 mL of sample-containing fluid. The tube body may be configured to have a headspace volume of at least 2 mL when the sample-containing fluid is present inside the tube body. The diameter of the openings may be about 2.8 mm to about 3.2 mm. The filter may be configured to filter molecules that enter from a first surface of the filter and exit from a second surface on the opposite side of the filter. The surface area of ​​the first surface of the filter is about 100 mm². 2 ~about 200mm 2 It is possible that the ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1It is possible that the tube body includes a snap-fit ​​ridge and a flange. The snap-fit ​​ridge may be configured to engage with a recess in the dispense cap. The flange may be configured to contact the proximal end of the dispense cap. The force required to snap the dispense cap onto the tube body may be about 20 N to 100 N. The force required to remove the dispense cap from the tube body after snap-fitting may be at least about 30 N. The tube body and the dispense cap may be cast as a piece of plastic. In embodiments where the tube body and the dispense cap are cast as a piece of plastic, the filter tube assembly may further include at least one tether connecting the tube body to the dispense cap. In embodiments where the tube body and the dispense cap are cast as a piece of plastic, the plastic of the tube body and the dispense cap may have a Young's modulus in the range of 200 to 700 MPa. A seal may cover the open end of the tube body. The tube body may include a filling line indicating the minimum volume of the molecular assay. The filter tube assembly may contain a buffer. The buffer may be contained within the internal volume of the tube body. The filter may be configured to prepare the sample-containing fluid for use in a gonorrhea assay, a chlamydia assay, or a trichomoniasis assay. The molecular assay may be a point-of-care molecular assay. The dispensing cap may further include a collar, and the tube body may include a neck region that can engage with the collar of the dispensing cap to form a fluid-tight seal (e.g., a plug seal). The collar and the neck region may engage via an interference fit. The thickness of the wall at the proximal end of the collar of the dispensing cap may be less than the thickness of the wall at the distal end of the collar of the dispensing cap. The outer diameter of the wall at the proximal end of the collar of the dispensing cap may be less than the outer diameter of the wall at the distal end of the collar of the dispensing cap.The collar of the dispense cap may include a first ridge, and the neck region of the tube body may include a second ridge, and the first and second ridges may be slidably engaged. The tube body may include a base portion positioned near the closed end of the tube body, and the base region may have a diameter smaller than the diameter of the collar. The dispense cap may include one or more retaining bumps configured to hold the filter within the dispense cap.

[0009] In another embodiment, a method for preparing a sample for a molecular assay is provided. The method may include the step of fixing a dispense cap having a filter to the open end of a tube body. The method may include the step of compressing the tube body two or fewer times, thereby pushing the sample-containing buffer out of the internal volume of the tube body as a continuous stream through the filter and out of the dispense cap, while retaining at least some of the inhibitors of the molecular assay from the sample-containing buffer in the filter. The method may include the step of performing the molecular assay using the filtered sample-containing buffer.

[0010] The step of compressing the tube body may allow at least about 2.5 mL to about 3.0 mL of filtered sample-containing buffer to be dispensed from the dispense cap. The step of securing the dispense cap to the tube body may include securing the dispense cap to the tube body via a snap-fit ​​connection. The molecular assay may include amplification of nucleic acids in the filtered sample-containing buffer. The method may further include introducing the sample into the buffer to form the sample-containing buffer, the buffer being held within the internal volume of the tube body. The step of compressing the tube body may include one, two, or three compressions of the tube body. The molecular assay may be an amplification assay. The method may further include removing a travel cap from the open end of the tube body before securing the dispense cap to the open end of the tube body. The method may further include removing and / or destroying a seal covering the open end of the tube body. The dispense cap may include a channel and an opening. The channel may include a transition region. The diameter of the filter may be about 1.2 to about 1.6 times the diameter of the transition region of the channel. The diameter of the filter may be in the range of about 12 mm to about 16 mm. The diameter of the transition region may be in the range of about 8 mm to about 12 mm. The step of compressing the tube body may include filtering molecules from the sample-containing buffer that enters the first surface of the filter and exits the second surface of the filter, and the surface area of ​​the filter may be about 100 mm². 2 ~about 200mm 2 It is possible that the ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 It is possible.

[0011] In yet another aspect, a filter tube assembly for preparing a sample-containing fluid for use in a molecular assay is provided. The filter tube assembly can comprise a dispense cap having a flow path and an opening. The flow path can have a transition region. The filter tube assembly can also comprise a filter positioned within the dispense cap, and the diameter of the filter can be about 1.2 to about 1.6 times the diameter of the transition region of the flow path. The filter tube assembly can also comprise a tube body having an open end and a closed end, and the tube body can be configured to hold a sample-containing fluid. The dispense cap can be configured to be fixed to the open end of the tube body. At least a portion of the tube body can comprise a flexible material, and the flexible material can be configured to force at least a portion of the sample-containing fluid to pass through the filter, the flow path, and the opening when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed. The dispense cap can be configured to propel a continuous stream of the filtered sample-containing fluid through the opening. The diameter of the filter can be in the range of about 12 mm to about 16 mm. The diameter of the transition region can be in the range of about 8 mm to about 12 mm.

[0012] In yet another aspect, a filter tube assembly for preparing a sample-containing fluid for use in a molecular assay is provided. The filter tube assembly can comprise a dispense cap having a flow path and an opening. The filter tube assembly can also comprise a filter positioned within the dispense cap, and the filter can be configured to filter molecules from a sample-containing fluid entering through a first surface of the filter and exiting through a second surface of the filter. The surface area of the filter can be about 100 mm 2 ~ about 200 mm 2This is possible. The filter tube assembly may comprise a tube body having an open end and a closed end, the tube body being configured to hold the sample-containing fluid within its internal volume. The dispense cap may be configured to be fixed to the open end of the tube body. At least a portion of the tube body may include a flexible material, the flexible material being configured to force at least a portion of the sample-containing fluid through the filter, the flow path, and the opening when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed. The dispense cap may be configured to propel a continuous stream of filtered sample-containing fluid through the opening. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 It is possible.

[0013] The embodiments provided herein include those numbered as follows: 1. A filter tube assembly for preparing a sample-containing fluid for use in molecular assays, A dispense cap having a flow path and an opening, A filter positioned within the dispense cap, A tube body having an open end and a closed end, Equipped with, The tube body is configured to hold the sample-containing fluid, The dispense cap is configured to be fixed to the open end of the tube body, At least a portion of the tube body is made of a flexible material, The flexible material is configured such that, when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed, at least a portion of the sample-containing fluid is forced to pass through the filter, the flow path, and the opening. The dispense cap is configured to propel approximately 2.5 mL to approximately 3.0 mL of filtered sample-containing fluid through the opening as a continuous stream during two or fewer compressions of the flexible material. A filter tube assembly characterized by the following features. 2. The filter tube assembly is configured to propel a continuous flow of at least about 1 mL of filtered sample-containing fluid through the opening during a single compression of the tube. A filter tube assembly according to Embodiment 1, characterized by the features described herein. 3. The flow path has a transition region located near the filter, The transition region is configured to reduce the back pressure applied to the filter when the flexible material is compressed. A filter tube assembly according to embodiment 1 or 2, characterized by the features described herein. 4. The diameter of the filter is approximately 1.2 to 1.6 times the diameter of the transition region. A filter tube assembly according to Embodiment 3, characterized by the features described herein. 5. The diameter of the transition region is approximately 8 mm to approximately 12 mm. The filter tube assembly according to Embodiment 4, characterized by the features described herein. 6. A retaining ring configured to secure the filter to the dispense cap. A filter tube assembly according to any one of embodiments 1 to 5, further comprising the above. 7. The retaining ring has a groove configured to fit with the ridge on the inner surface of the dispense cap. The filter tube assembly according to embodiment 6, characterized in that 8. The filter is a cup filter having a wall configured to secure the filter to the dispense cap. A filter tube assembly according to any one of embodiments 1 to 5, characterized by the features described herein. 9. The hardness of the material of the dispense cap is greater than the hardness of the material of the tube body. A filter tube assembly according to any one of embodiments 1 to 8, characterized by the features described herein. 10. The Young's modulus of the material of the dispense cap is at least twice that of the material of the tube body. A filter tube assembly according to embodiment 9, characterized in that... 11. The Young's modulus of the material of the dispense cap is at least about 800 MPa. A filter tube assembly according to any one of embodiments 1 to 10, characterized by the features described herein. 12. The Young's modulus of the material of the tube body is approximately 200 to approximately 300 MPa. A filter tube assembly according to any one of embodiments 1 to 11, characterized by the features described herein. 13. The dispense cap contains high-density polyethylene (HDPE) or polypropylene. A filter tube assembly according to any one of embodiments 1 to 12, characterized by the features described herein. 14. The material of the tube body includes linear low-density polyethylene (LLDPE). A filter tube assembly according to any one of embodiments 1 to 13, characterized by the features described herein. 15. The dispense cap further comprises a tethering ring configured to engage with the outside of the tube body. A filter tube assembly according to any one of embodiments 1 to 14, characterized by the features described herein. 16. A travel cap configured to be fixed to the open end of the tube body. Furthermore, The travel cap has a collar configured to suppress fluid leakage from the internal volume of the tube body when the travel cap is fixed to the open end of the tube body. A filter tube assembly according to any one of embodiments 1 to 15, characterized by the features described herein. 17. The travel cap has a threaded portion configured to engage with the threaded portion of the tube body. A filter tube assembly according to embodiment 16, characterized by the features described herein. 18. The dispense cap has a threaded portion configured to engage with the threaded portion of the tube body. A filter tube assembly according to any one of embodiments 1 to 17, characterized by the features described herein. 19. The tube body is at least partially transparent to visible light. A filter tube assembly according to any one of embodiments 1 to 18, characterized in that it is a filter tube assembly. 20. The thickness of at least a portion of the wall of the tube body is approximately 0.2 mm to approximately 1.0 mm. A filter tube assembly according to any one of embodiments 1 to 19, characterized in that it is a filter tube assembly. 21. The filter has a plurality of openings having diameters ranging from approximately 1 μm to approximately 250 μm. A filter tube assembly according to any one of embodiments 1 to 20, characterized by the features described herein. 22. The filter includes polyethylene, glass fiber, polypropylene, or polytetrafluoroethylene. A filter tube assembly according to any one of embodiments 1 to 21, characterized by the features described herein. 23. The tube body has an internal volume of approximately 3 mL to approximately 5 mL. A filter tube assembly according to any one of embodiments 1 to 22, characterized by the features described herein. 24. The tube body is configured to hold approximately 2.5 mL to approximately 3.5 mL of sample-containing fluid. A filter tube assembly according to any one of embodiments 1 to 23, characterized by the features described herein. 25. The tube body is configured to have a headspace volume of at least 2 mL when the sample-containing fluid is present inside the tube body. A filter tube assembly according to any one of embodiments 1 to 24, characterized by the features described herein. 26. The opening has a diameter, which is approximately 2.8 mm to approximately 3.2 mm. A filter tube assembly according to any one of embodiments 1 to 25, characterized by the features described herein. 27. The filter is configured to filter molecules that enter from the first surface of the filter and exit from the second surface on the opposite side of the filter. The surface area of ​​the first surface of the filter is approximately 100 mm². 2 ~about 200mm 2 That is A filter tube assembly according to any one of embodiments 1 to 26, characterized by the features described herein. 28. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 That is A filter tube assembly according to embodiment 27, characterized by the features described herein. 29. The tube body further comprises a snap-fit ​​ridge and a flange, The snap-fit ​​ridge is configured to engage with the recess of the dispense cap. The flange is configured to contact the proximal end of the dispense cap. A filter tube assembly according to any one of embodiments 1 to 28, characterized by the features described herein. 30. The force required to attach the dispense cap to the tube body is approximately 20N to 100N. A filter tube assembly according to any one of embodiments 1 to 29, characterized by the features described herein. 31. The force required to remove the dispense cap from the tube body after it has been snap-fitted is at least about 30 N. A filter tube assembly according to any one of embodiments 1 to 30, characterized by the features described herein. 32. The tube body and the dispense cap are cast as a single piece of plastic. The filter tube assembly further comprises at least one tether connecting the tube body to the dispense cap. A filter tube assembly according to any one of embodiments 1 to 8 and 16 to 31, characterized by the features described herein. 33. The plastic of the tube body and the dispense cap has a Young's modulus of 200 to 700 MPa. A filter tube assembly according to embodiment 32, characterized by the features described herein. 34. A seal covering the open end of the tube body. A filter tube assembly according to embodiment 32 or 33, further comprising the above. 35. The tube body has a filling line indicating the minimum volume of the molecular assay. A filter tube assembly according to any one of embodiments 1 to 34, characterized by the features described herein. 36. Buffer solution contained within the internal volume of the tube body A filter tube assembly according to any one of embodiments 1 to 35, further comprising the above. 37. The filter is configured to prepare the sample-containing fluid for use in a gonorrhea assay, a chlamydia assay, or a trichomoniasis assay. A filter tube assembly according to any one of embodiments 1 to 36, characterized by the features described herein. 38. The molecular assay described above is a point-of-care molecular assay. A filter tube assembly according to any one of embodiments 1 to 37, characterized by the features described herein. 39. The dispense cap further has a color, The tube body has a neck region configured to engage with the collar of the dispense cap to form a fluid-tight seal. The collar and the neck region are configured to engage with each other via interference fit. A filter tube assembly according to any one of embodiments 1 to 38, characterized by the features described herein. 40. The thickness of the wall at the proximal end of the collar of the dispense cap is smaller than the thickness of the wall at the distal end of the collar of the dispense cap. A filter tube assembly according to embodiment 39, characterized by the features described herein. 41. The outer diameter of the wall at the proximal end of the collar of the dispense cap is smaller than the outer diameter of the wall at the distal end of the collar of the dispense cap. A filter tube assembly according to embodiment 39 or 40, characterized in that... 42. The collar of the dispense cap has a first ridge, The neck region of the tube body has a second ridge, The first ridge and the second ridge are configured to engage in a sliding manner. A filter tube assembly according to any one of embodiments 39 to 41, characterized in that it is a filter tube assembly. 43. The tube body further has a base portion positioned near the closed end of the tube body, The base portion has a diameter smaller than the diameter of the neck region. A filter tube assembly according to any one of embodiments 39 to 42, characterized in that it is a filter tube assembly. 44. The dispense cap has one or more retaining bumps configured to hold the filter within the dispense cap. A filter tube assembly according to any one of embodiments 1 to 43, characterized by the features described herein. 45. A method for preparing a sample for a molecular assay, The process involves fixing a dispense cap with a filter to the open end of the tube body, A step of compressing the tube body two or fewer times, thereby promoting the discharge of the sample-containing buffer from the internal volume of the tube body as a continuous stream through the filter and out of the dispense cap, while retaining at least some of the inhibitors of the molecular assay from the sample-containing buffer within the filter. The steps include: performing the molecular assay using the filtered sample-containing buffer; A method characterized by comprising: 46. ​​The step of compressing the tube body involves dispensing at least approximately 2.5 mL to approximately 3.0 mL of filtered sample-containing buffer from the dispense cap. The method according to embodiment 45, characterized by the features described herein. 47. The step of fixing the dispense cap to the tube body includes the step of fixing the dispense cap to the tube body via a snap-fit ​​connection. The method according to embodiment 45 or 46, characterized by the features described herein. 48. The molecular assay includes amplification of nucleic acids in the filtered sample-containing buffer. The method according to any one of embodiments 45 to 47, characterized by the features described herein. 49. Step of introducing the sample into the buffer in order to form the sample-containing buffer. Furthermore, The buffer solution is held within the internal volume of the tube body. The method according to any one of embodiments 45 to 48, characterized by the features described herein. 50. The molecular assay is an amplification assay. The method according to any one of embodiments 45 to 49, characterized by the features described herein. 51. Before the step of fixing the dispense cap to the open end of the tube body, the step of removing the travel cap from the open end of the tube body. The method according to any one of embodiments 45 to 50, further comprising the above. 52. Step of removing the seal covering the open end of the tube body. The method according to any one of embodiments 45 to 51, further comprising the above. 53. The dispense cap has a flow path and an opening, The aforementioned channel has a transition region, The diameter of the filter is approximately 1.2 to 1.6 times the diameter of the transition region of the flow path. The method according to any one of embodiments 45 to 52, characterized by the features described herein. 54. The diameter of the filter is in the range of approximately 12 mm to approximately 16 mm. The diameter of the transition region is in the range of approximately 8 mm to approximately 12 mm. The method according to any one of embodiments 45 to 53, characterized by the features described herein. 55. The step of compressing the tube body includes filtering molecules from the sample-containing buffer that enters the first surface of the filter and exits from the second surface of the filter, The surface area of ​​the aforementioned filter is approximately 100 mm². 2 ~about 200mm 2 That is The method according to any one of embodiments 45 to 54, characterized by the features described herein. 56. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 That is The method according to any one of embodiments 45 to 55, characterized by the features described herein. 57. A filter tube assembly for preparing a sample-containing fluid for use in molecular assays, A dispense cap having a flow path and an opening, A filter positioned within the dispense cap, A tube body having an open end and a closed end, Equipped with, The aforementioned channel has a transition region, The diameter of the filter is approximately 1.2 to 1.6 times the diameter of the transition region of the flow path. The tube body is configured to hold the sample-containing fluid, The dispense cap is configured to be fixed to the open end of the tube body, At least a portion of the tube body is made of a flexible material, The flexible material is configured such that, when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed, at least a portion of the sample-containing fluid is forced to pass through the filter, the flow path, and the opening. The dispense cap is configured to propel a continuous stream of filtered sample-containing fluid through the opening. A filter tube assembly characterized by the following features. 58. The diameter of the filter is in the range of approximately 12 mm to approximately 16 mm. The diameter of the transition region is in the range of approximately 8 mm to approximately 12 mm. A filter tube assembly according to embodiment 57, characterized in that... 59. A filter tube assembly for preparing a sample-containing fluid for use in molecular assays, A dispense cap having a flow path and an opening, A filter positioned within the dispense cap, A tube body having an open end and a closed end, Equipped with, The filter is configured to filter molecules from a sample-containing fluid that enters from the first surface of the filter and exits from the second surface of the filter. The surface area of ​​the aforementioned filter is approximately 100 mm². 2 ~about 200mm 2 And, The tube body is configured to hold the sample-containing fluid within its internal volume. The dispense cap is configured to be fixed to the open end of the tube body, At least a portion of the tube body is made of a flexible material, The flexible material is configured such that, when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed, at least a portion of the sample-containing fluid is forced to pass through the filter, the flow path, and the opening. The dispense cap is configured to propel a continuous stream of filtered sample-containing fluid through the opening. A filter tube assembly characterized by the following features. 60. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 That is A filter tube assembly according to embodiment 59, characterized in that...

[0014] The embodiments described above, as well as other features, aspects, and advantages of the embodiments of this disclosure, will be described in relation to various implementations with reference to the accompanying drawings. The embodiments described are merely examples and are not intended to be limiting. Throughout the drawings, similar reference numerals indicate similar components unless the context indicates otherwise. [Brief explanation of the drawing]

[0015] [Figure 1A] Figures 1A and 1B show an exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are separate components. [Figure 1B] Figures 1A and 1B show an exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are separate components.

[0016] [Figure 2A]Figures 2A to 2F show diagrams of the dispense caps included in the filter tube assemblies of Figures 1A and 1B. [Figure 2B] Figures 2A to 2F show diagrams of the dispense caps included in the filter tube assemblies of Figures 1A and 1B. [Figure 2C] Figures 2A to 2F show diagrams of the dispense caps included in the filter tube assemblies of Figures 1A and 1B. [Figure 2D] Figures 2A to 2F show diagrams of the dispense caps included in the filter tube assemblies of Figures 1A and 1B. [Figure 2E] Figures 2A to 2F show diagrams of the dispense caps included in the filter tube assemblies of Figures 1A and 1B. [Figure 2F] Figures 2A to 2F show diagrams of the dispense caps included in the filter tube assemblies of Figures 1A and 1B.

[0017] [Figure 3A] Figures 3A to 3C show diagrams of the filters included in the filter tube assembly shown in Figures 1A and 1B. [Figure 3B] Figures 3A to 3C show diagrams of the filters included in the filter tube assembly shown in Figures 1A and 1B. [Figure 3C] Figures 3A to 3C show diagrams of the filters included in the filter tube assembly shown in Figures 1A and 1B.

[0018] [Figure 4A] Figures 4A to 4C show diagrams of the retaining rings included in the filter tube assemblies of Figures 1A and 1B. [Figure 4B] Figures 4A to 4C show diagrams of the retaining rings included in the filter tube assemblies of Figures 1A and 1B. [Figure 4C]Figures 4A to 4C show diagrams of the retaining rings included in the filter tube assemblies of Figures 1A and 1B.

[0019] [Figure 5A] Figures 5A to 5D show diagrams of the tube bodies included in the filter tube assemblies of Figures 1A and 1B. [Figure 5B] Figures 5A to 5D show diagrams of the tube bodies included in the filter tube assemblies of Figures 1A and 1B. [Figure 5C] Figures 5A to 5D show diagrams of the tube bodies included in the filter tube assemblies of Figures 1A and 1B. [Figure 5D] Figures 5A to 5D show diagrams of the tube bodies included in the filter tube assemblies of Figures 1A and 1B.

[0020] [Figure 6] Figure 6 shows a cross-sectional view of the filter tube assembly shown in Figures 1A and 1B.

[0021] [Figure 7] Figure 7 shows a cross-sectional view of the filter and retaining ring positioned within the dispense cap of the filter tube assembly shown in Figures 1A and 1B.

[0022] [Figure 8A] Figures 8A to 8C show exemplary steps of attaching a retaining ring to a tube body and closing the open end of the tube body with a dispense cap, according to one embodiment of the present disclosure. [Figure 8B] Figures 8A to 8C show exemplary steps of attaching a retaining ring to a tube body and closing the open end of the tube body with a dispense cap, according to one embodiment of the present disclosure. [Figure 8C]Figures 8A to 8C show exemplary steps of attaching a retaining ring to a tube body and closing the open end of the tube body with a dispense cap, according to one embodiment of the present disclosure.

[0023] [Figure 9A] Figures 9A to 9D show an exemplary travel cap together with the tube body according to one embodiment of the present disclosure. [Figure 9B] Figures 9A to 9D show an exemplary travel cap together with the tube body according to one embodiment of the present disclosure. [Figure 9C] Figures 9A to 9D show an exemplary travel cap together with the tube body according to one embodiment of the present disclosure. [Figure 9D] Figures 9A to 9D show an exemplary travel cap together with the tube body according to one embodiment of the present disclosure.

[0024] [Figure 10A] Figures 10A to 10D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component. [Figure 10B] Figures 10A to 10D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component. [Figure 10C] Figures 10A to 10D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component. [Figure 10D]Figures 10A to 10D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component.

[0025] [Figure 11A] Figures 11A to 11D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component. [Figure 11B] Figures 11A to 11D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component. [Figure 11C] Figures 11A to 11D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component. [Figure 11D] Figures 11A to 11D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are a single component.

[0026] [Figure 12A] Figures 12A to 12D show the dispense caps included in the filter tube assembly shown in Figures 11A to 11D. [Figure 12B] Figures 12A to 12D show the dispense caps included in the filter tube assembly shown in Figures 11A to 11D. [Figure 12C]Figures 12A to 12D show the dispense caps included in the filter tube assembly shown in Figures 11A to 11D. [Figure 12D] Figures 12A to 12D show the dispense caps included in the filter tube assembly shown in Figures 11A to 11D.

[0027] [Figure 13A] Figures 13A to 13D show diagrams of the filters included in the filter tube assembly shown in Figures 11A to 11D. [Figure 13B] Figures 13A to 13D show diagrams of the filters included in the filter tube assembly shown in Figures 11A to 11D. [Figure 13C] Figures 13A to 13D show diagrams of the filters included in the filter tube assembly shown in Figures 11A to 11D. [Figure 13D] Figures 13A to 13D show diagrams of the filters included in the filter tube assembly shown in Figures 11A to 11D.

[0028] [Figure 14A] Figures 14A to 14D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 11A to 11D. [Figure 14B] Figures 14A to 14D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 11A to 11D. [Figure 14C] Figures 14A to 14D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 11A to 11D. [Figure 14D] Figures 14A to 14D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 11A to 11D.

[0029] [Figure 15A] Figures 15A and 15B show illustrations of seals that may be used in the filter tube assemblies shown in Figures 11A to 11D. [Figure 15B] Figures 15A and 15B show illustrations of seals that may be used in the filter tube assemblies shown in Figures 11A to 11D.

[0030] [Figure 16A] Figures 16A to 17 show cross-sectional views of the filter tube assembly shown in Figures 11A to 11D, illustrating the interaction between the dispense cap, the tube body, and the filter. [Figure 16B] Figures 16A to 17 show cross-sectional views of the filter tube assembly shown in Figures 11A to 11D, illustrating the interaction between the dispense cap, the tube body, and the filter. [Figure 16C] Figures 16A to 17 show cross-sectional views of the filter tube assembly shown in Figures 11A to 11D, illustrating the interaction between the dispense cap, the tube body, and the filter. [Figure 17] Figures 16A to 17 show cross-sectional views of the filter tube assembly shown in Figures 11A to 11D, illustrating the interaction between the dispense cap, the tube body, and the filter.

[0031] [Figure 18A] Figures 18A and 18D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 11A to 11D for use. [Figure 18B] Figures 18A and 18D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 11A to 11D for use. [Figure 18C] Figures 18A and 18D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 11A to 11D for use. [Figure 18D] Figures 18A and 18D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 11A to 11D for use.

[0032] [Figure 19A]Figures 19A to 19D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are separate components. [Figure 19B] Figures 19A to 19D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are separate components. [Figure 19C] Figures 19A to 19D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are separate components. [Figure 19D] Figures 19A to 19D show another exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. In this example, the tube body and the dispensing cap are separate components.

[0033] [Figure 20A] Figures 20A to 20E show diagrams of the dispense caps included in the filter tube assembly shown in Figures 19A to 19D. [Figure 20B] Figures 20A to 20E show diagrams of the dispense caps included in the filter tube assembly shown in Figures 19A to 19D. [Figure 20C] Figures 20A to 20E show diagrams of the dispense caps included in the filter tube assembly shown in Figures 19A to 19D. [Figure 20D] Figures 20A to 20E show diagrams of the dispense caps included in the filter tube assembly shown in Figures 19A to 19D. [Figure 20E] Figures 20A to 20E show diagrams of the dispense caps included in the filter tube assembly shown in Figures 19A to 19D.

[0034] [Figure 21A] Figures 21A to 21D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 19A to 19D. [Figure 21B] Figures 21A to 21D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 19A to 19D. [Figure 21C] Figures 21A to 21D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 19A to 19D. [Figure 21D] Figures 21A to 21D show diagrams of the tube bodies included in the filter tube assembly shown in Figures 19A to 19D.

[0035] [Figure 22] Figure 22 shows the filter tube assembly from Figures 19A to 19D, along with the seal.

[0036] [Figure 23A] Figures 23A to 24 show cross-sectional views of the filter tube assembly shown in Figures 19A to 19D, illustrating the interaction between the dispense cap, the tube body, and the filter. [Figure 23B] Figures 23A to 24 show cross-sectional views of the filter tube assembly shown in Figures 19A to 19D, illustrating the interaction between the dispense cap, the tube body, and the filter. [Figure 24] Figures 23A to 24 show cross-sectional views of the filter tube assembly shown in Figures 19A to 19D, illustrating the interaction between the dispense cap, the tube body, and the filter.

[0037] [Figure 25A] Figures 25A to 25D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 19A to 19D for use. [Figure 25B]Figures 25A to 25D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 19A to 19D for use. [Figure 25C] Figures 25A to 25D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 19A to 19D for use. [Figure 25D] Figures 25A to 25D illustrate exemplary steps for preparing the filter tube assembly shown in Figures 19A to 19D for use.

[0038] [Figure 26] Figure 26 is an illustrative flowchart of a method for using the filter tube assembly according to this disclosure.

[0039] [Figure 27] Figure 27 plots the optical density at a wavelength of 600 nm of the sample-containing fluid after filtration using the filter tube assembly according to this disclosure.

[0040] [Figure 28] Figure 28 is a box plot showing the concentration of human genomic DNA in the sample-containing fluid after filtration using the filter tube assembly according to this disclosure.

[0041] [Figure 29A] Figures 29A to 29C plot the time course of fluorescence in a molecular assay for urine samples filtered using the filter tube assembly according to this disclosure and for unfiltered urine samples. [Figure 29B] Figures 29A to 29C plot the time course of fluorescence in a molecular assay for urine samples filtered using the filter tube assembly according to this disclosure and for unfiltered urine samples. [Figure 29C]Figures 29A to 29C plot the time course of fluorescence in a molecular assay for urine samples filtered using the filter tube assembly according to this disclosure and for unfiltered urine samples.

[0042] [Figure 30] Figure 30 plots the mean cycle threshold (Ct) of PCR assays for trichomoniasis and gonorrhea using unfiltered samples and samples filtered using the filter tube assembly according to the present disclosure. [Modes for carrying out the invention]

[0043] Embodiments of this disclosure provide devices, systems, and methods for preparing solutions, such as fluid samples, for use in molecular assays. Such molecular assays may be used, for example, for the detection of genomic material, which may originate from specimens such as bacteria, viruses, yeast, and / or parasites. Fluid samples may contain a test sample in a buffer solution. In some cases, the fluid sample is prepared for amplification after being discharged from the device as one or more streams (e.g., one or more consecutive streams of filtered fluid sample from the device) from the device's internal volume through the device's filter. Filtering the fluid sample prepares it for inclusion in a molecular assay by removing molecules that may interfere with the molecular assay, for example. For example, a portion of the fluid sample may be transferred from the device's internal volume to a test vessel where a molecular assay, such as an amplification assay, may be performed. Throughout this disclosure, exemplary systems, kits, and methods are described as relating to the collection, filtration, testing, and detection of nucleic acids. However, it will be understood that the technology of the present invention can be used for the collection, testing, and detection of any particles, molecules, or analytes.

[0044] Embodiments of the devices, systems, and methods described herein can advantageously prepare complex crude matrices for detecting target nucleic acids in a point-of-care environment, allowing for the removal of assay inhibitors by filtration and clarification of the specimen. In particular, embodiments of the devices, systems, and methods described herein can clarify complex crude specimens such as vaginal matrices, urine, pharyngeal, and nasal swab matrices using a CLIA-compatible non-instrumental approach in a point-of-care environment. Accordingly, the devices, systems, and methods of the disclosure can advantageously omit instruments such as centrifugation and solid-phase purification, and the additional steps required to use such instruments. Advantageously, known inhibitors of nucleic acid amplification can be removed from the crude matrix, while there is little to no loss of analytes from the specimen. Accordingly, embodiments of the disclosure can detect target analytes such as bacteria, viruses, yeasts, and parasites with higher sensitivity. Furthermore, embodiments of the devices, systems, and methods of the disclosure can be performed with little to no clogging of the filtration element (an event that can result in failure of the test event).

[0045] As an exemplary example, a collection kit including a filter tube assembly disclosed herein includes a swab, the filter tube assembly, and a test device. The swab may be made of a material having desired abrasiveness, pickup efficiency, and detachment efficiency for detecting a target analyte such as nucleic acids. The swab may be provided on a handle. The user may use the swab and handle to collect samples such as vaginal swabs, pharyngeal swabs, and nasal swabs. After swabbing, the user may place the swab inside the tube body of the filter tube assembly. The handle may include a break point (tear point) such that the user can break off the swab inside the tube body by angling the handle against the inner surface of the tube body without physically contacting the swab with a surface that may contaminate the swab. In some examples, the sample may be a liquid sample such as an oral fluid sample or a urine sample from a patient.

[0046] A liquid, such as an extraction buffer, may be provided within the tube body of the filter tube assembly. In examples using a swab, the swab may absorb the extraction buffer when it is placed within the tube body of the filter tube assembly. The user can close the dispense cap of the filter tube assembly over the tube body of the filter tube assembly. The user can compress the tube body, thereby squeezing out the absorbed extraction buffer and collected analytes (such as nucleic acids) from the swab. In some examples where the user does not break off the swab within the tube body, the user can add the analytes collected on the swab to the extraction buffer by mixing the swab in the extraction buffer within the tube body and then removing the swab from the tube body. In some examples, for example, if a fluid sample is collected, the fluid sample may be added directly to the extraction buffer within the tube body. After the sample is added to the extraction buffer and the dispense cap of the filter tube assembly is closed over the tube body, the user can compress the tube body to propel (dispense) the sample-containing fluid through the fluid path of the dispense cap to the test device so that it passes through the filter of the filter tube assembly. The filtered sample-containing fluid produced by the apparatus or system of this disclosure may, but is not limited to, be used in molecular assays, such as gonorrhea assays, chlamydia assays, or trichomoniasis assays. Molecular assays may be point-of-care assays. For example, molecular assays may be performed in the office of a clinician and / or healthcare provider.

[0047] In the following, various embodiments will be described with reference to the drawings for illustrative purposes. It should be understood that many other implementations of the disclosed concept are possible, and various advantages may be achieved by the disclosed implementations.

[0048] [A. A filter tube assembly comprising a disc filter, a separate tube body, and a separate dispensing cap.] Figures 1A and 1B show an exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to one embodiment of the present disclosure. Figure 1A shows an exemplary filter tube assembly 100 in a side view. Figure 1B shows the exemplary filter tube assembly 100 of Figure 1A in an exploded side view. The filter tube assembly 100 may comprise a filter 102 (e.g., a disk filter), a dispensing cap 104, and a tube body 106. In some embodiments, the filter tube assembly 100 may comprise a retaining ring 108 and a tethering ring 110. The filter tube assembly 100 may be used to prepare a sample-containing fluid for use in a molecular assay. The tube body 106 may be capable of holding a fluid, for example, a buffer or a sample-containing fluid. When open, the tube body 106 may be capable of receiving a sample, for example, a swab from which a sample has been taken. When the dispense cap 104 is attached to the tube body 106 and the tube body 106 is compressed, the filter tube assembly 100 can propel the sample-containing fluid out of the internal volume of the tube body 106 through the filter 102 and out of the dispense cap 104.

[0049] In some examples, the filter tube assembly 100 is capable of propelling (spraying) filtered sample-containing fluid from a dispense cap 104 in one or more streams (for example, at a significantly higher dispensing rate than a dropper). In some embodiments of the filter tube assembly according to this disclosure, the dispense cap is configured to propel a continuous stream of filtered sample-containing fluid through the opening during each compression of the tube body. Advantageously, embodiments of the filter tube assembly can deliver large volumes of filtered sample-containing fluid rapidly and accurately through the opening with minimal user intervention. This minimizes the risk of the filtered sample-containing fluid being exposed to, degraded, or damaged by environmental or user-derived contaminants before it is delivered to the test device on which the molecular assay is performed. In one non-limiting embodiment described below, the filter tube assembly according to this disclosure is configured to propel approximately 2.5 to approximately 3.0 mL of filtered sample-containing fluid through the opening as a continuous stream during one, two, three, or four compressions of the tube body. In one embodiment, a total volume of filtered sample-containing fluid of approximately 2.5 to 3.0 mL is propelled through the opening during two or fewer compressions of the tube body. Each compression may result in multiple continuous streams of fluid being propelled through the opening. Alternatively, compression of the tube body may result in a single continuous stream of fluid being propelled through the opening.

[0050] When filtered using the filter tube assembly 100, the sample-containing fluid is prepared for use in molecular assays. For example, the filter tube assembly 100 may be capable of removing by filtration certain molecules and / or particles that may interfere with the molecular assay. Exemplary inhibitors that can be removed by embodiments of the filter tube assembly described herein include proteins (blood-based and non-blood-based), carbohydrates (e.g., mucins), immunoglobulins, cells and cell debris, host microbiota, human genomic DNA (hugDNA), and salts. Advantageously, embodiments of the filter tube assembly according to this disclosure can remove these and other inhibitors, thereby significantly improving assay sensitivity, shortening DNA and RNA amplification times, and in some cases preventing test failures caused by excess inhibitors in the crude matrix.

[0051] Molecular assays may require relatively large volumes of sample-containing liquid compared to other assay types (e.g., immunoassays). Therefore, it may be desirable that the filter tube assembly 100 according to the embodiments of this disclosure be able to rapidly and / or easily dispense the total volume as presented herein. Since the filter tube assembly 100 is capable of propelling the filtered sample-containing fluid out of the dispensing cap, filtration is relatively rapid (e.g., within a few seconds of compressing the tube body 106, or immediately in response to compression of the tube body 106). In some embodiments, the filter tube assembly 100 can release the total volume of filtered sample-containing fluid by compressing the tube body 106 two or fewer times. This compression can be provided by the user compressing the tube body 106. In some other embodiments, the filter tube assembly 100 can release the total volume of filtered sample-containing fluid by compressing the tube body 106 one, two, three, or four times.

[0052] In several embodiments, the filter tube assembly 100 contains approximately 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, 3.7 mL, 3.8 mL, 3.9 mL, 4.0 mL, 4.1 mL, 4.2 mL, 4.3 mL, 4.4 mL, 4.5 mL, 4.6 mL, 4.7 mL, 4.8 mL, and approximately The filter tube assembly 100 can dispense a total amount of 4.9 mL, approximately 5.0 mL, approximately 5.1 mL, approximately 5.2 mL, approximately 5.3 mL, approximately 5.4 mL, approximately 5.5 mL, approximately 5.6 mL, approximately 5.7 mL, approximately 5.8 mL, approximately 5.9 mL, approximately 6.0 mL, approximately 6.1 mL, approximately 6.2 mL, approximately 6.3 mL, approximately 6.4 mL, approximately 6.5 mL, approximately 6.6 mL, approximately 6.7 mL, approximately 6.8 mL, approximately 6.9 mL, or approximately 7.0 mL, or a total amount of any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the filter tube assembly 100 can dispense a total amount of approximately 2 mL to approximately 4 mL of filtered fluid. Additionally or alternatively, in some embodiments, the filter tube assembly 100 is capable of dispensing a total volume of approximately 2.5 mL to approximately 3 mL of filtered fluid.

[0053] In some embodiments, during a single compression of the tube body 106, the filter tube assembly 100 filters out approximately 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL, 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, and 2.6 mL of the filtered fluid. The total amount that can be dispensed is approximately 0.5 mL to 2 mL of filtered fluid per compression of the tube body 106. Additionally or alternatively, in some embodiments, the filter tube assembly 100 is capable of dispensing a total amount of filtered fluid of approximately 0.5 mL to approximately 1.5 mL per compression of the tube body 106.

[0054] [1. Dispensing cap] Figures 2A to 2F show a dispense cap 104 included in a filter tube assembly 100 according to one embodiment of the present disclosure. Figure 2A shows a perspective view of the dispense cap 104. Figure 2B shows a side view of the dispense cap 104. Figure 2C shows a perspective side view of the dispense cap 104. Figure 2D shows a perspective bottom view of the dispense cap 104. Figure 2E shows a cross-sectional side view of the dispense cap 104. Figure 2F shows an enlarged view of the cross-sectional view in Figure 2E.

[0055] The dispensing cap 104 may include an opening 202, a flow path 204, a filter cavity 208, an internal space 214, a proximal end 216, a nozzle 220, and a cap body 224. In some embodiments, the dispensing cap 104 may also include a tethering ring 110 and an arm 218. In some embodiments, the dispensing cap 104 may include a plurality of buttresses (auxiliary walls) 222. The dispensing cap 104 may also include one or more ridges 210 and recesses 212. The flow path 204 may include a transition region 206.

[0056] The flow path 204 may be a hollow space within the dispense cap 104, for example, a hollow space within the nozzle 220 of the dispense cap 104. The opening 202 may be a hole at the distal end of the nozzle 220. The flow path 204 may allow one or more propulsion streams of the sample-containing fluid (e.g., filtered sample-containing fluid) to flow out of the dispense cap 104. In some embodiments, the diameter of the opening 202 may be approximately 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the opening 202 may have a diameter of approximately 2 mm to 4 mm. Additionally or alternatively, in some embodiments, the opening 202 may have a diameter of about 2.8 mm to about 3.2 mm. The filter cavity 208 may be a space capable of receiving and holding the filter 102 according to embodiments of the present disclosure. When the filter 102 is positioned within the dispense cap 104, the inner wall of the filter cavity 208 may be in contact with the filter 102. The filter 102 may be in contact with the distal surface 226 of the filter cavity 208, for example, when the filter 102 is secured within the filter cavity 208 by the retaining ring 108. The transition region 206 may be positioned in the vicinity of the filter cavity 208.

[0057] The transition region 206 may provide a volume through which the sample-containing fluid can be propelled to exit the filter 102. The transition region 206 has a larger diameter than the rest of the flow path 204. Therefore, the transition region 206 does not significantly narrow the diameter of the flow path, thus reducing the back pressure acting on the filter 102 (i.e., the pressure inside the tube body 106 when the tube body 106 is compressed). By reducing the pressure acting on the filter 102, the transition region 206 can reduce the risk of the filter 102 breaking, rupturing, and / or slipping when the tube body 106 is compressed. In some embodiments, the diameter of the transition region 206 may be approximately 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the transition region 206 may have a diameter of approximately 8 mm to 12 mm. Additionally or alternatively, in some embodiments, the transition region 206 may have a diameter of approximately 10 mm.

[0058] The nozzle 220 may extend away from the cap body 224. The inner surface of the nozzle 220 may define a portion of the flow path 204. In some embodiments, the dispensing cap 104 may be supported (reinforced) by a plurality of buttresses 222. The buttresses 222 may stabilize the nozzle 220 and / or prevent or suppress damage to the nozzle 220.

[0059] The arm 218 may extend from the cap body 224 to the tethering 110. The arm 218 may be bendable and / or foldable to allow the tethering 110 to approach the proximal end 216 of the dispense cap 104. The material of the dispense cap 104 and / or the dimensions of the arm 218 may affect the folding and / or bending ability of the arm 218. The tethering 110 may be attached to the tube body 106 so that the dispense cap 104 can be coupled to the tube body 106 even when the dispense cap 104 is not attached to the open end 502 of the tube body 106 (see Figure 5A). In one embodiment, the tethering 110 is coupled to the tube body 106 by encircling the tube body 106 between teeth 508 (described later with reference to Figures 5A to 5C).

[0060] The cap body 224 may include an internal space 214. The cap body 224 may be sized and shaped to engage with the open end 502 of the tube body 106. The inner surface of the cap body 224 may include ridges 210 and recesses 212 that are engageable with the feature portion of the tube body 106, as will be described later with reference to Figure 6. The ridges 210 and recesses 212 may extend over at least a portion of the circumference of the inner surface of the cap body 224. The cap body 224 may also include a second ridge 210 positioned near the filter cavity 208. The filter cavity 208 may be positioned between the second ridge 210 and the flow path 204. The filter cavity 208 may be sized such that the inner surface of the cap body 224 contacts the side surface 304 of the filter 102 (see Figures 3A to 3C). The second ridge 210 can engage with the groove 406 of the retaining ring 108 (see Figures 4A and 4B), thereby allowing the retaining ring 108 to be held in place relative to the dispensing cap 104. The second ridge 210 may extend over at least a portion of the circumference of the inner surface of the cap body 224.

[0061] In some embodiments, the dispense cap 104 may include plastic. In some embodiments, the plastic may be polypropylene or high-density polyethylene. The dimensions and material of the dispense cap 104 may be selected such that the dispense cap 104 is substantially undeformed or deforms only minimally when the tube body 106 of the filter tube assembly 100 is compressed. In some embodiments, the Young's modulus of the material of the dispense cap 104 is approximately 800 MPa, approximately 810 MPa, approximately 820 MPa, approximately 830 MPa, approximately 840 MPa, approximately 850 MPa, approximately 860 MPa, approximately 870 MPa, approximately 880 MPa, approximately 890 MPa, approximately 900 MPa, approximately 910 MPa, approximately 920 MPa, approximately 930 MPa, approximately 940 MPa, approximately 950 MPa, approximately 960 MPa, approximately 970 MPa, approximately 980 MPa, approximately 990 MPa, approximately 1000MPa, approximately 1010MPa, approximately 1020MPa, approximately 1030MPa, approximately 1040MPa, approximately 1050MPa, approximately 1060MPa, approximately 1070MPa, approximately 1080MPa, approximately 1090MPa, approximately 1100MPa , about 1110MPa, about 1120MPa, about 1130MPa, about 1140MPa, about 1150MPa, about 1160MPa, about 1170MPa, about 1180MPa, about 1190MPa, about 1200MPa, about 1210MPa a, about 1220MPa, about 1230MPa, about 1240MPa, about 1250MPa, about 1260MPa, about 1270MPa, about 1280MPa, about 1290MPa, about 1300MPa, about 1310MPa, about 1320 MPa, approximately 1330MPa, approximately 1340MPa, approximately 1350MPa, approximately 1360MPa, approximately 1370MPa, approximately 1380MPa, approximately 1390MPa, approximately 1400MPa, approximately 1410MPa, approximately 1420MPa, approximately 14 30MPa, approximately 1440MPa, approximately 1450MPa, approximately 1460MPa, approximately 1470MPa, approximately 1480MPa, approximately 1490MPa, approximately 1500MPa, approximately 1510MPa, approximately 1520MPa, approximately 1530MPa, approximately 1540MPa, approximately 1550MPa, approximately 1560MPa, approximately 1570MPa, approximately 1580MPa, approximately 1590MPa, approximately 1600MPa, approximately 1610MPa, approximately 1620MPa, approximately 1630MPa, approximately 1640MPa,Approximately 1650 MPa, approximately 1660 MPa, approximately 1670 MPa, approximately 1680 MPa, approximately 1690 MPa, approximately 1700 MPa, approximately 1710 MPa, approximately 1720 MPa, approximately 1730 MPa, approximately 1740 MPa, approximately 1750 MPa, approximately 1760 MPa, approximately 1770 MPa, approximately 1780 MPa, approximately 1790 MPa, approximately 1800 MPa, approximately 1810 MPa, approximately 1820 MPa, approximately 1830 MPa, approximately 1840 MPa, approximately 1850 MPa, approximately 1860 MPa, approximately 1870 MPa, approximately 1880 MPa, approximately 1890 MPa, approximately 1900 MPa, approximately 1910 MPa, approximately 1920 MPa, approximately 1930 MPa, approximately 1940 MPa, approximately 1950 MPa, approximately 1960 MPa, approximately 1970 MPa, approximately It could be 1980 MPa, approximately 1990 MPa, approximately 2000 MPa, approximately 2010 MPa, approximately 2020 MPa, approximately 2030 MPa, approximately 2040 MPa, approximately 2050 MPa, approximately 2060 MPa, approximately 2070 MPa, approximately 2080 MPa, approximately 2090 MPa, approximately 3000 MPa, approximately 3010 MPa, approximately 3020 MPa, approximately 3030 MPa, approximately 3040 MPa, approximately 3050 MPa, approximately 3060 MPa, approximately 3070 MPa, approximately 3080 MPa, approximately 3090 MPa, or approximately 4000 MPa, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 104 may be about 1600 MPa to about 2000 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 104 may be about 1700 MPa to about 1800 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 104 may be about 1200 MPa to about 1500 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 104 may be about 1300 MPa to about 1400 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 104 may be about 900 MPa to about 1100 MPa. In some embodiments, the hardness of the material of the dispense cap 104 isThe hardness of the material of the tube body 106 may be greater than that of the material of the dispense cap 104 (for example, the Young's modulus of the material of the dispense cap 104 may be greater than that of the material of the tube body 106). In some embodiments, the Young's modulus of the material of the dispense cap 104 is at least about 1.4 times, about 1.5 times, about 1.6 times, about 1.7 times, about 1.8 times, about 1.9 times, about 2.0 times, about 2.1 times, about 2.2 times, about 2.3 times, about 2.4 times, about 2.5 times, about 2.6 times, about 2.7 times, about 2.8 times, about 2.9 times, about 3.0 times, about 3.1 times, about 3.2 times, about 3.3 times, about 3.4 times, about 3.5 times, about It may be 3.6 times, approximately 3.7 times, approximately 3.8 times, approximately 3.9 times, approximately 4.0 times, approximately 4.1 times, approximately 4.2 times, approximately 4.3 times, approximately 4.4 times, approximately 4.5 times, approximately 4.6 times, approximately 4.7 times, approximately 4.8 times, approximately 4.9 times, or approximately 5.0 times greater, or it may be a multiple of any value or range inside any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, multiples of values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 104 may be at least a multiple of "2" greater (i.e., at least twice as large) than the Young's modulus of the material of the tube body 106.

[0062] In alternative embodiments to those described with reference to Figures 2A to 2F, the dispense cap 104 may include a threaded portion that can interact with the threaded portion of the tube body 106. In such embodiments, the user can secure the dispense cap 104 to the tube body 106 by rotating the dispense cap 104 relative to the tube body 106 to engage (screw) the threaded portions. In such embodiments, the dispense cap 104 may not snap-fit ​​to the tube body 106.

[0063] [2. Disk Filter] Figures 3A to 3C show a filter 102 included in a filter tube assembly 100 according to one embodiment of the present disclosure. Figure 3A shows a perspective view of the filter 102. Figure 3B shows a side view of the filter 102. Figure 3C shows a plan view of the filter 102. The filter 102 may be a cylindrical disc filter. The disc filter may have a cylindrical shape with a height less than its diameter. The filter 102 may include a first surface 302, a side surface 304, and a second surface 306. The first surface 302 and / or the second surface 306 may be circular. The first surface 302 and the second surface 306 may have a diameter 308. When positioned within the dispense cap 104, the first surface 302 may be oriented toward the internal space 214, and the second surface 306 may be oriented toward the flow path 204 and / or opening 202.

[0064] In certain embodiments, the diameter 308 of the filter 102 may be approximately 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, or 30 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the diameter 308 may be approximately 12 mm to 16 mm. Additionally or alternatively, in some embodiments, the diameter 308 may be approximately 14 mm.

[0065] In certain embodiments, the surface area of ​​the first surface 302 or the second surface 306 is approximately 50 mm². 2 , about 60mm 2 , about 70mm 2 , about 80mm 2 , about 90mm 2 Approximately 100mm 2 , about 110mm 2 , about 120mm2 , about 130mm 2 , about 140mm 2 , about 150mm 2 , about 160mm 2 , about 170mm 2 , about 180mm 2 , about 190mm 2 , about 200mm 2 , about 210mm 2 , about 220mm 2 , about 230mm 2 , about 240mm 2 , about 250mm 2 , about 260mm 2 , about 270mm 2 , about 280mm 2 , about 290mm 2 , about 300mm 2 , about 310mm 2 , about 320mm 2 , about 330mm 2 , about 340mm 2 , about 350mm 2 , about 360mm 2 , about 370mm 2 , about 380mm 2 , about 390mm 2 , or approximately 400mm 2 It may be any value or range inside either of these ranges or numerical values, or any range bounded by either of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the surface area of ​​the first surface 302 or the second surface 306 is approximately 100 mm². 2 ~about 200mm 2 This is possible. Additionally or alternatively, in some embodiments, the surface area of ​​the first surface 302 or the second surface 306 is approximately 140 mm². 2 ~approx. 160mm 2 It is possible.

[0066] In certain embodiments, the thickness 310 of the filter 102 may be approximately 0.1 mm, approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1.0 mm, approximately 1.1 mm, approximately 1.2 mm, approximately 1.3 mm, approximately 1.4 mm, approximately 1.5 mm, approximately 1.6 mm, approximately 1.7 mm, approximately 1.8 mm, approximately 1.9 mm, approximately 2.0 mm, approximately 2.1 mm, approximately 2.2 mm, approximately 2.3 mm, approximately 2.4 mm, approximately 2.5 mm, approximately 2.6 mm, approximately 2.7 mm, approximately 2.8 mm, approximately 2.9 mm, or approximately 3.0 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 310 may be about 0.8 mm to about 1.2 mm. Additionally or alternatively, in some embodiments, the thickness 310 may be about 1 mm. Additionally or alternatively, in some embodiments, the thickness 310 may be about 1.3 mm to about 1.8 mm. Additionally or alternatively, in some embodiments, the thickness 310 may be about 1.6 mm.

[0067] In some embodiments, the filter may include a porous material. The size of the pores may affect which particles are filtered (removed by filtration) as the sample-containing fluid passes through the filter 102. The pore size may be desirable to be small enough to remove particles that could interfere with the molecular assay. The pore size may be desirable to be large enough to allow sufficient volume and velocity of fluid flow through the filter 102 and / or to reduce the risk of the filter 102 becoming clogged with particles. The sizes of the pores in porous materials (e.g., average pore diameter) are approximately 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 45 μm, 50 μm, 55 μm, 60 μm, 65 μm, 70 μm, 75 μm, 80 μm, 85 μm, 90 μm, and 95 μm. The size may be approximately μm, about 100 μm, about 110 μm, about 120 μm, about 130 μm, about 140 μm, about 150 μm, about 160 μm, about 170 μm, about 180 μm, about 190 μm, or about 200 μm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 5 μm to about 25 μm. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 10 μm to about 20 μm. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 50 μm to about 120 μm. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 20 μm to about 25 μm. Additionally or alternatively, in some embodiments, the size of the pores may be about 5 μm to about 15 μm. The porous material may contain multiple winding pathways. In some embodiments, the porous material may be hydrophobic. In some embodiments, the porous material may include polyethylene (PE), polypropylene (PP), or polytetrafluoroethylene (PTFE).In some embodiments, the porous material may be hydrophilic. In some embodiments, the porous material may include glass fibers or meltblown polypropylene (PP). In some embodiments, the porous material may be a sintered porous material. In some embodiments, the porous material may be sintered PE.

[0068] In one non-limiting embodiment, the filter comprises a plurality of membranes, at least one of which has different properties (e.g., different pore sizes and / or different hydrophobic / hydrophilic properties). The plurality of membranes may be arranged in a stacked configuration. One membrane may be positioned near a retaining ring (if provided) and function as a prefilter. The membrane functioning as a prefilter may have pores of a size and / or shape for retaining larger particles, while one or more downstream membranes may have pores of a size and / or shape for retaining smaller particles. In one non-limiting embodiment, a first tube assembly is configured to dispense a first sample-containing fluid intended to be tested for a first analyte and comprises a filter comprising a single membrane. A second tube assembly is configured to dispense a second sample-containing fluid intended to be tested for a second analyte different from the first analyte and comprises a filter comprising two membranes. The second sample-containing fluid may contain a crude matrix for which a two-stage filtration method is optimal for the first sample-containing fluid.

[0069] [3. Retaining ring] Figures 4A to 4C show a retaining ring 108 included in a filter tube assembly 100 according to one embodiment of the present disclosure. Figure 4A shows a perspective view of the retaining ring 108. Figure 4B shows a side view of the retaining ring 108. Figure 4C shows a plan view of the retaining ring 108.

[0070] The retaining ring 108 may include a groove 406, a distal surface 410, and a proximal surface 412. In some embodiments, the retaining ring 108 may include a notch 408. The retaining ring 108 may have an inner diameter 402 and an outer diameter 404. In some embodiments, the retaining ring 108 may include plastic. In some embodiments, the retaining ring 108 may include polypropylene.

[0071] The outer diameter 404 may be selected such that when the retaining ring 108 is positioned within the dispense cap 104, the outer surface of the retaining ring 108 contacts the surface of the internal space 214 of the dispense cap 104. The retaining ring 108 may be positioned within the dispense cap 104 to secure the filter 102 within the filter cavity 208 of the dispense cap 104. When the filter 102 and the retaining ring 108 are positioned within the dispense cap 104, the distal surface 410 of the retaining ring 108 may contact the first surface 302 of the filter 102. The distal surface 410 of the retaining ring 108 can push the filter 102 toward and / or into contact with the distal surface 226 of the filter cavity 208. In some embodiments, the outer diameter 404 may be approximately 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, or 30 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the outer diameter 404 may be approximately 12 mm to 16 mm. Additionally or alternatively, in some embodiments, the inner diameter 402 may be approximately 13 mm to 15 mm. Additionally or alternatively, in some embodiments, the inner diameter 402 may be approximately 14 mm.

[0072] The groove 406 may extend along at least a portion of the outer circumference of the retaining ring 108. The groove 406 may be a recess, depression, etc., on the outer circumference of the retaining ring 108. The groove 406 may engage with the second ridge 210 of the dispense cap 104. The groove 406 may be shaped and / or dimensional such that it engages firmly with the second ridge 210 when the retaining ring 108 is positioned within the dispense cap 104. The groove 406 may be shaped and / or dimensional such that, when engaged with the second ridge 210, the groove 406 and the second ridge 210 form a fluid-tight barrier.

[0073] In some embodiments, the notch 408 may extend along at least a portion of the height of the outer surface of the retaining ring 108. The notch 408 may increase the flexibility of the retaining ring 108. For example, the increased flexibility provided by the notch 408 on the retaining ring 108 may allow the retaining ring 108 to be more easily positioned within the dispense cap 104, for example, in a position where the second ridge 210 is engaged by the groove 406.

[0074] The inner diameter 402 may be selected such that the retaining ring 108 has appropriate strength and / or flexibility. The inner diameter 402 may be selected such that when the tube body 106 is compressed, a sufficient area of ​​the first surface 302 of the filter 102 is exposed to the sample-containing fluid, thereby allowing one or more streams of the filtered sample-containing fluid to be propelled into the flow path 204. The one or more streams may be a continuous stream of fluid propelled into the flow path 204. In some embodiments, the inner diameter 402 may be about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the inner diameter 402 may be approximately 8 mm to approximately 12 mm. Additionally or alternatively, in some embodiments, the inner diameter 402 may be approximately 9 mm to approximately 11 mm. Additionally or alternatively, in some embodiments, the inner diameter 402 may be approximately 10 mm to approximately 11 mm. Additionally or alternatively, in some embodiments, the inner diameter 402 may be approximately 10.5 mm.

[0075] [4. Tube body] Figures 5A to 5C show a tube body 106 included in a filter tube assembly 100 according to one embodiment of the present disclosure. Figure 5A shows a perspective view of the tube body 106. Figure 5B shows a side view of the tube body 106. Figure 5C shows a cross-sectional side view of the tube body 106. Figure 5D shows a perspective view of the tube body 106 seen from above. The tube body 106 may include an open end 502, a snap-fit ​​ridge 504, a flange 506, a plurality of teeth 508, a filling line 510, a wall 512, a closed end 514, and an internal volume 516.

[0076] The internal volume 516 is capable of holding a fluid, such as a sample-containing fluid. In some embodiments, the fluid is a buffer to which the sample is added, forming the sample-containing fluid. The dispense cap 104 may be positioned on the open end 502 of the tube body 106, and the internal space 214 of the dispense cap 104 may be fluidly connected to the internal volume 516, allowing the filter 102 to be in contact with the sample-containing fluid when the tube body 106 is compressed and / or the filter tube assembly 100 is inverted.In several embodiments, the internal volume 516 in an uncompressed state was approximately 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, 3.7 mL, 3.8 mL, 3.9 mL, 4.0 mL, 4.1 mL, 4.2 mL, 4.3 mL, 4.4 mL, and 4.5 mL. mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5.0mL, about 5.1mL, about 5.2mL, about 5.3mL, about 5.4mL, about 5.5mL, about 5.6mL, about 5.7mL, about 5.8mL, about 5.9mL, about 6.0mL, about 6.1mL, about 6.2mL, about 6.3mL, about 6.4mL, about 6.5mL, about 6.6mL, about 6.7mL, about 6.8mL, about 6.9mL, about 7.0mL, about 7.1mL, about 7.2mL, about 7.3mL, about 7.4mL , about 7.5mL, about 7.6mL, about 7.7mL, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8.5mL, about 8.6mL, about 8.7mL, about 8.8mL, about 8. 9mL, about 9.0mL, about 9.1mL, about 9.2mL, about 9.3mL, about 9.4mL, about 9.5mL, about 9.6mL, about 9.7mL, about 9.8mL, about 9.9mL, about 10.0mL, about 10.1mL, about 10.2mL, about 10.3 It may be mL, approximately 10.4 mL, approximately 10.5 mL, approximately 10.6 mL, approximately 10.7 mL, approximately 10.8 mL, approximately 10.9 mL, approximately 11 mL, approximately 11.5 mL, approximately 12 mL, approximately 12.5 mL, approximately 13 mL, approximately 13.5 mL, approximately 14 mL, approximately 14.5 mL, or approximately 15 mL, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the internal volume 516 may be approximately 4 mL to approximately 6 mL in an uncompressed state. Additionally or alternatively, in some embodiments, the internal volume 516 may be approximately 5 mL.In several embodiments, the tube body 106 contained approximately 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, and 3.7 mL of the sample-containing fluid. , about 3.8mL, about 3.9mL, about 4.0mL, about 4.1mL, about 4.2mL, about 4.3mL, about 4.4mL, about 4.5mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5.0mL, about 5.1mL, about 5.2mL, about 5.3mL, 5.4mL, 5.5mL, 5.6mL, 5.7mL, 5.8mL, 5.9mL, 6.0mL, 6.1mL, 6.2mL, 6.3mL, 6.4mL, 6.5mL, 6.6mL, 6.7mL, 6.8mL, 6.9mL, approx. 7.0mL, about 7.1mL, about 7.2mL, about 7.3mL, about 7.4mL, about 7.5mL, about 7.6mL, about 7.7mL, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8.5mL, about 8 .6mL, approx. 8.7mL, approx. 8.8mL, approx. 8.9mL, approx. 9.0mL, approx. 9.1mL, approx. 9.2mL, approx. 9.3mL, approx. 9.4mL, approx. It can hold 10.2 mL, approximately 10.3 mL, approximately 10.4 mL, approximately 10.5 mL, approximately 10.6 mL, approximately 10.7 mL, approximately 10.8 mL, approximately 10.9 mL, approximately 11 mL, approximately 11.5 mL, approximately 12 mL, approximately 12.5 mL, approximately 13 mL, approximately 13.5 mL, approximately 14 mL, approximately 14.5 mL, or approximately 15 mL, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, amounts of values ​​outside these numerical values ​​or ranges may also be used (and can be held).Additionally or alternatively, in some embodiments, the tube body 106 is capable of holding approximately 2 mL to approximately 4 mL of the sample-containing fluid. Additionally or alternatively, in some embodiments, the tube body 106 is capable of holding approximately 3 mL of the sample-containing fluid. In some embodiments, the tube body 106 is capable of holding approximately 1.0 mL, approximately 1.1 mL, approximately 1.2 mL, approximately 1.3 mL, approximately 1.4 mL, approximately 1.5 mL, approximately 1.6 mL, approximately 1.7 mL, approximately 1.8 mL, approximately 1.9 mL, approximately 2.0 mL, approximately 2.1 mL, approximately 2.2 mL, approximately 2.3 mL, approximately 2.4 mL, approximately 2.5 mL of the headspace volume (e.g., the volume of the tube body 106 not occupied by the fluid when the buffer or sample-containing fluid is present in the tube body 106). 2.6mL, 2.7mL, 2.8mL, 2.9mL, 3.0mL, 3.1mL, 3.2mL, 3.3mL, 3.4mL, 3.5mL, 3.6mL, 3.7mL, 3.8mL, 3.9mL, 4.0mL , about 4.1mL, about 4.2mL, about 4.3mL, about 4.4mL, about 4.5mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5.0mL, about 5.1mL, about 5.2mL, about 5.3mL, about 5.4mL, about 5.5m L, about 5.6mL, about 5.7mL, about 5.8mL, about 5.9mL, about 6.0mL, about 6.1mL, about 6.2mL, about 6.3mL, about 6.4mL, about 6.5mL, about 6.6mL, about 6.7mL, about 6.8mL, about 6.9mL, about 7.0 mL, about 7.1mL, about 7.2mL, about 7.3mL, about 7.4mL, about 7.5mL, about 7.6mL, about 7.7mL, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8. This may include 5 mL, approximately 8.6 mL, approximately 8.7 mL, approximately 8.8 mL, approximately 8.9 mL, approximately 9.0 mL, approximately 9.1 mL, approximately 9.2 mL, approximately 9.3 mL, approximately 9.4 mL, approximately 9.5 mL, approximately 9.6 mL, approximately 9.7 mL, approximately 9.8 mL, approximately 9.9 mL, or approximately 10.0 mL, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, volumes of values ​​outside these numerical values ​​or ranges may also be used (may include).Additionally or alternatively, in some embodiments, the tube body 106 may contain approximately 1 mL to approximately 3 mL of headspace volume. Additionally or alternatively, in some embodiments, the tube body 106 may contain approximately 2 mL of headspace volume.

[0077] In some embodiments, the internal volume 516 of the tube body 106 can be reduced to propel the sample-containing fluid from the filter tube assembly 100 to a test device for performing, for example, a molecular assay (e.g., diffusion amplification). The reduction of the internal volume 516 can be achieved in several ways. In the first embodiment shown in Figures 5A to 5C, the material of the tube body 106 is flexible enough to allow a user to compress the wall 512 of the tube body 106 to propel one or more streams of filtered sample-containing fluid through the opening 202 of the dispense cap 104 to the test device. The one or more streams may be a continuous stream of fluid propelled through the opening 202. The flexibility may result from a combination of the thickness of the wall 512 and the modulus of elasticity (e.g., Young's modulus) of the material contained in the tube body 106. For example, the thickness of the material near the open end 502 and the closed end 514 may be equal to or greater than the thickness of the wall 512. The combination of the wall thickness 512 and the material of the tube body 106 can be selected so that the tube body 106 is compressible by the user. In a second embodiment, the tube body 106 may have a thin-walled portion in the wall 512 extending axially and / or radially, which provides a hinge point to the tube body 106. At this hinge point, the wall 512 can bend, while the other portion of the wall 512 is thicker and / or stiffer. In this case, the user can compress the tube body 106, and the tube body 106 flexes at the thin-walled hinge point, reducing the internal volume 516 and pushing the sample-containing fluid through the filter 102 and the channel 204 and out of the opening 202 of the dispense cap 104, but the wall 512 is not thin enough to flex completely. Other approaches are also possible for propelling a stream or other volume of the sample-containing fluid from the tube body 106 through the dispense cap 104. In other embodiments, the tube body 106 may not require compression or squeezing to dispense fluid from the filter tube assembly 100, and may dispense fluid droplets when the filter tube assembly 100 is inverted.

[0078] In some embodiments, the thickness 518 of the material of the tube body 106 near the open end 502 may be equal to or greater than the thickness 520 of the wall 512. In some embodiments, the thickness 522 of the material of the closed end 514 may be equal to or greater than the thickness 520 of the wall 512. In some embodiments, the thickness 520 of the wall 512 may be about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, about 0.55 mm, about 0.60 mm, about 0.65 mm, about 0.70 mm, about 0.75 mm, about 0.80 mm, about 0.85 mm, about 0.90 mm, about 0.95 mm, or about 1.0 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 520 may be approximately 0.40 mm to approximately 0.60 mm. Additionally or alternatively, in some embodiments, the thickness 520 may be approximately 0.50 mm to approximately 0.60 mm. In some embodiments, the thickness 518 near the opening end 502 may be 0.60 mm, approximately 0.65 mm, approximately 0.70 mm, approximately 0.75 mm, approximately 0.80 mm, approximately 0.85 mm, approximately 0.90 mm, approximately 0.95 mm, approximately 1.0 mm, approximately 1.1 mm, approximately 1.2 mm, approximately 1.3 mm, approximately 1.4 mm, or approximately 1.5 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 518 may be approximately 0.90 mm to approximately 1.1 mm. Additionally or alternatively, in some embodiments, the thickness 518 may be approximately 1.0 mm to approximately 1.1 mm.In some embodiments, the thickness 522 of the closed end 514 can be 0.60 mm, about 0.65 mm, about 0.70 mm, about 0.75 mm, about 0.80 mm, about 0.85 mm, about 0.90 mm, about 0.95 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, or about 1.5 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values outside of these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 522 can be from about 0.70 mm to about 1.0 mm. Additionally or alternatively, in some embodiments, the thickness 522 can be from about 0.80 mm to about 0.90 mm.

[0079] In some embodiments, the tube body 106 may include plastic. In some embodiments, the plastic may be polyethylene. In some embodiments, the plastic may be low-density polyethylene (LDPE). In some embodiments, the Young's modulus of the material of the tube body 106 is approximately 70 MPa, approximately 80 MPa, approximately 90 MPa, approximately 100 MPa, approximately 110 MPa, approximately 120 MPa, approximately 130 MPa, approximately 140 MPa, approximately 150 MPa, approximately 160 MPa, approximately 170 MPa, approximately 180 MPa, approximately 190 MPa, approximately 200 MPa, approximately 210 MPa, approximately 220 MPa, approximately 230 MPa, approximately 240 MPa, approximately 250 MPa, approximately 260 MPa, approximately 270 MPa, approximately 280 MPa, approximately 290 MPa, and approximately 300 MPa. Approximately 310 MPa, approximately 320 MPa, approximately 330 MPa, approximately 340 MPa, approximately 350 MPa, approximately 360 MPa, approximately 370 MPa, approximately 380 MPa, approximately 390 MPa, approximately 400 MPa, approximately 410 MPa, approximately 420 MPa, approximately 430 MPa, approximately 440 MPa, approximately 450 MPa, approximately 460 MPa, approximately 470 MPa, approximately 480 MPa, approximately 490 MPa, approximately 500 MPa, approximately 510 MPa, approximately 520 MPa, approximately 530 MPa, approximately 540 MPa, approximately 550 MPa, approximately 560 MPa, approximately 570 MPa, Approximately 580 MPa, approximately 590 MPa, approximately 600 MPa, approximately 610 MPa, approximately 620 MPa, approximately 630 MPa, approximately 640 MPa, approximately 650 MPa, approximately 660 MPa, approximately 670 MPa, approximately 680 MPa, approximately 690 MPa, approximately 700 MPa, approximately 710 MPa, approximately 720 MPa, approximately 730 MPa, approximately 740 MPa, approximately 750 MPa, approximately 760 MPa, approximately 770 MPa, approximately 780 MPa, approximately 790 MPa, approximately 800 MPa, approximately 810 MPa, approximately 820 MPa, approximately 830 MPa, approximately 840 MPa, approximately It could be 850 MPa, approximately 860 MPa, approximately 870 MPa, approximately 880 MPa, approximately 890 MPa, approximately 900 MPa, approximately 910 MPa, approximately 920 MPa, approximately 930 MPa, approximately 940 MPa, approximately 950 MPa, approximately 960 MPa, approximately 970 MPa, approximately 980 MPa, approximately 990 MPa, or approximately 1 MPa, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values.In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 106 may be about 200 Pa to about 700 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 106 may be about 200 Pa to about 300 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 106 may be about 90 Pa to about 200 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 106 may be about 800 Pa to about 950 MPa. In some embodiments, the hardness of the material of the tube body 106 may be lower than the hardness of the material of the dispense cap 104 (for example, the Young's modulus of the material of the tube body 106 may be lower than the Young's modulus of the material of the dispense cap 104).

[0080] The material contained in the tube body 106 may be optically transparent, for example, transparent to visible light. In some embodiments, the transparency of the material of the tube body 106 may allow the user to visually inspect the amount (volume) of sample-containing fluid and / or buffer held in the internal volume 516. The filling line 510 may indicate to the user whether a sufficient amount of sample-containing fluid and / or buffer is present in the internal volume 516 of the tube body 106. In some embodiments, as shown in Figures 5A to 5C, the filling line 510 may be a raised feature molded into the wall 512. In some embodiments, the filling line 510 may be a recess molded into the wall 512. In some embodiments, the filling line 510 may be printed on the wall 512 using, for example, ink or other marking material. In some embodiments, the tube body 106 may include a plurality of filling lines 510. In such embodiments, each filling line 510 may indicate a different volume (amount). When the filter tube assembly 100 is oriented such that the dispense cap 104 is facing upward and the closed end 514 of the tube body 106 is facing downward, the user may be able to compare the vertical position of the upper surface of the buffer and / or sample-containing fluid in the internal volume 516 with the position of the filling line 510. In some embodiments, the filling line 510 may indicate whether or not the minimum volume of sample-containing fluid required to perform the molecular assay is present. In some embodiments where the buffer fluid is stored in the internal volume 516 for several days, weeks, months, and / or years, the filling line 510 may indicate whether or not the buffer volume has been lost beyond a threshold indicated by the filling line 510 due to evaporation, leakage, and / or escape from, for example, the tube body 106.

[0081] The dispensing cap 104 can be positioned on and / or above the open end 502. The snap-fit ridge 504 of the tube body 106 can engage with the recess 212 of the dispensing cap 104. In some embodiments, the recess 212 and the snap-fit ridge 504 can fit together to form a snap-fit connection (described below with reference to FIG. 6). When positioned on and / or above the open end 502, the proximal end 216 of the dispensing cap 104 can abut against the flange 506. In some embodiments, it is not necessary for the proximal end 216 to abut against the flange 506 to confirm that an effective seal is formed between the dispensing cap 104 and the tube body 106. Thereby, the flange 506 can prevent the dispensing cap 104 from further moving in the direction of the closed end 514 of the tube body 106.

[0082] A plurality of teeth 508 can be positioned on the outer surface of the tube body 106. The plurality of teeth 508 can be positioned closer to the open end 502 than the closed end 514. In some embodiments, the plurality of teeth 508 are positioned in the vicinity of the flange 506. Two, three, four, or more teeth can be positioned along the circumference of the outer surface of the wall 512. FIGS. 5A through 5C show an embodiment including four teeth 508 positioned equidistantly along the circumference of the outer surface of the wall 512. The teeth 508 can engage with the tether ring 110 of the dispensing cap 104 (see FIGS. 8A and 8B, which show the positioning of the retaining ring 108 of the dispensing cap relative to the plurality of teeth 508).

[0083] [5. Assembly including a dispensing cap, a disk filter, and a tube body] Figure 6 shows a cross-sectional view of a filter tube assembly 100 according to one embodiment of the present disclosure. When the dispense cap 104 is attached to the open end 502 of the tube body 106, the recess 212 and ridge 210 of the dispense cap 104 may engage with the snap-fit ​​ridge 504 of the tube body 106. When the dispense cap 104 is attached to the tube body 106, for example by a snap-fit ​​connection, the proximal end 216 of the dispense cap 104 may abut against the flange 506 of the tube body 106. In some embodiments, the proximal end 216 does not need to abut against the flange 506 in order to ensure that an effective seal is formed between the dispense cap 104 and the tube body 106.

[0084] The shapes of the recess 212, the ridge 210, and the snap-fit ​​ridge 504 can each affect the magnitude of the force required to attach the dispense cap 104 to the tube body 106 and / or the magnitude of the force required to remove the dispense cap 104 from the tube body 106. For example, the shape and / or angle of the recess curvature 602, the ridge curvature 604, and the incline 606 can each be modified to increase and / or decrease the force required to snap the dispense cap 104 onto the tube body 106 and / or the force required to remove the dispense cap 104 from the tube body 106. For example, as shown in Figure 6, the incline 606 may be a relatively gentle slope. If the incline 606 is relatively gentle, the force required to attach (snap into, in this non-limiting embodiment) the dispense cap 104 to the tube body 106 may be relatively small. Increasing the incline (steepness) of the slope 606 can increase the force required to attach the dispense cap 104 to the tube body 106. In some embodiments, the force required to attach the dispense cap 104 to the tube body 106 may be less than the force required to remove the dispense cap 104 from the tube body 106. In some embodiments, the force applied to attach the dispense cap 104 to the tube body 106 may be approximately 15N, 20N, 25N, 30N, 35N, 40N, 45N, 50N, 55N, 60N, 65N, 70N, 75N, 80N, 85N, 90N, 95N, 100N, 105N, 110N, 115N, or 120N, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the force applied to attach the dispense cap 104 to the tube body 106 may be approximately 40N to 80N.Additionally or alternatively, in some embodiments, the force applied to attach the dispense cap 104 to the tube body 106 may be about 50 N to about 70 N. Additionally or alternatively, in some embodiments, the force applied to attach the dispense cap 104 to the tube body 106 may be about 55 N to about 65 N. Additionally or alternatively, in some embodiments, the force applied to attach the dispense cap 104 to the tube body 106 may be about 55 N to about 60 N.

[0085] The shape, inclination, and / or curvature of the recess curvature 602 and the ridge curvature 604 can affect the force required to remove the dispense cap 104 from the tube body 106. The recess curvature 602 and the ridge curvature 604 can be shaped to resist the dispense cap 104 from detaching from the tube body 106. For example, as shown in Figure 6, both the recess curvature 602 and the ridge curvature 604 can be relatively steep, which may result in the need to apply a relatively large force to remove the dispense cap 104 from the tube body 106. The recess curvature 602 and / or ridge curvature 604 can be shaped to maintain the dispense cap 104 attached to the tube body 106 even when the pressure inside the internal volume 516 of the tube body 106 is well above atmospheric pressure, for example, due to compression of the tube body 106 by the user. In some embodiments, the force applied to remove the dispense cap 104 from the tube body 106 may be at least N, about 80N, about 85N, about 90N, about 95N, about 100N, about 105N, about 110N, about 115N, about 120N, about 125N, about 130N, about 135N, about 140N, about 145N, about 150N, about 155N, about 160N, about 165N, about 170N, about 175N, about 180N, about 185N, about 190N, about 195N, or about 200N, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the force applied to remove the dispense cap 104 from the tube body 106 may be at least about 125 N. Additionally or alternatively, in some embodiments, the force applied to remove the dispense cap 104 from the tube body 106 may be at least about 150 N. It may be desirable that the force applied to attach the dispense cap 104 to the tube body 106 be less than the force applied to remove the dispense cap 104 from the tube body 106.

[0086] Figure 7 shows a cross-sectional view of the filter 102 and retaining ring 108 positioned within the dispense cap 104. The dashed arrows indicate the direction of fluid flow through the dispense cap 104 when the tube body 106 of the filter tube assembly 100 is compressed (e.g., distal direction away from the proximal end 216 of the dispense cap 104). When the tube body 106 of the filter tube assembly 100 is compressed, the sample-containing fluid can flow out from the internal space 214 and / or internal volume 516 (fluidically connected) through the hollow space defined by the inner diameter 402 of the retaining ring 108, through the filter 102, through the flow path 204 (including the transition region 206, the intermediate portion 704 and the distal portion 702), and out through the opening 202.

[0087] As described above, the transition region 206 can reduce the back pressure acting on the filter 102 (i.e., the higher pressure in the internal space 214 relative to the pressure in the flow path 204). The transition region 206 provides a space having a diameter that is not excessively small but slightly smaller than the diameter of the filter 102 (e.g., the diameter of the first surface 302 or the second surface 306). In some embodiments, the diameter of filter 102 may be about 1.05 times, 1.10 times, 1.15 times, 1.20 times, 1.25 times, 1.30 times, 1.35 times, 1.40 times, 1.45 times, 1.50 times, 1.55 times, 1.60 times, 1.65 times, 1.70 times, 1.75 times, 1.80 times, 1.85 times, 1.90 times, 1.95 times, or 2.00 times larger than the diameter of transition zone 206, or about 1.70 times, 1.75 times, 1.80 times, 1.85 times, 1.90 times, 1.95 times, or 2.00 times larger, or may be a multiple of any value or range inside any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, multiples of values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the diameter of filter 102 may be approximately 1.2 to 1.6 times the diameter of the transition region 206. Additionally or alternatively, in some embodiments, the diameter of filter 102 may be approximately 1.3 to 1.5 times the diameter of the transition region 206. Additionally or alternatively, in some embodiments, the diameter of filter 102 may be approximately 1.35 to 1.45 times the diameter of the transition region 206. Additionally or alternatively, in some embodiments, the diameter of filter 102 may be approximately 1.4 times the diameter of the transition region 206.

[0088] The shape and / or dimensions of the distal portion 702 and the intermediate portion 704 of the flow path 204 may also affect the pressure applied to the filter 102. The inner surface of the dispense cap 104 defining the intermediate portion 704 (referred to as the curved portion 706) may preferably include a gentle curve so that the diameter of the flow path 204 does not decrease abruptly from the transition region 206 to the distal portion 702. Gradually changing the diameter of the flow path 204 can ensure that there is no abrupt increase or decrease in the pressure of the sample-containing fluid. The inner wall of the dispense cap 104 defining the distal portion 702 may be gently sloped such that the diameter of the proximal portion of the distal portion 702 (e.g., the portion adjacent to the intermediate portion 704) is larger than the diameter of the opening 202.

[0089] The ratio of the surface area of ​​the filter 102 to the size of the internal volume 516 can affect the maximum flow rate of the sample-containing fluid that flows out of the filter tube assembly 100 when the tube body 106 is compressed. This maximum flow rate is desirable to be sufficiently high, as described above, so that the filter tube assembly 100 can dispense the total amount of filtered sample-containing fluid for molecular assay with only one, two, three, or four compressions of the tube body 106. In some embodiments, the ratio a:v of the surface area (a) of the first surface 302 of the filter 102 to the internal volume 516(v) of the tube body 106 is approximately 15 m -1 , about 16m -1 , about 17m -1 , about 18m -1 , about 19m -1 , about 20m -1 , about 21m -1 , about 22m -1 , about 23m -1 , about 24m -1 , about 25m -1 , about 26m -1 , about 27m -1 , about 28m -1 , about 29m -1 , about 30m -1 , about 31m -1 , about 32m -1 , about 33m -1 , about 34m -1, approximately 35 m -1 , approximately 36 m -1 , approximately 37 m -1 , approximately 38 m -1 , approximately 39 m -1 , approximately 40 m -1 , approximately 41 m -1 , approximately 42 m -1 , approximately 43 m -1 , approximately 44 m -1 , approximately 45 m -1 , approximately 46 m -1 , approximately 47 m -1 , approximately 48 m -1 , approximately 49 m -1 , approximately 50 m -1 , approximately 51 m -1 , approximately 52 m -1 , approximately 53 m -1 , approximately 54 m -1 , approximately 55 m -1 , approximately 56 m -1 , approximately 57 m -1 , approximately 58 m -1 , approximately 59 m -1 , or approximately 60 m -1 , can be, or any value or range inside any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values, can be. In some cases, values outside these numerical values or ranges can also be used. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the first surface 302 of the filter 102 to the internal volume 516 (v) of the tube body 106 is approximately 20 m -1 ~ approximately 40 m -1 , can be. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the first surface 302 of the filter 102 to the internal volume 516 (v) of the tube body 106 is approximately 25 m -1 ~ approximately 35 m -1 , can be. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the first surface 302 of the filter 102 to the internal volume 516 (v) of the tube body 106 is approximately 30 m -1This is possible. The maximum flow rate may be affected by the inner diameter 402 of the retaining ring 108. This is because the surface area of ​​the first surface 302 of the filter 102 that contacts the distal surface 410 of the retaining ring 108 may be inaccessible to the sample-containing fluid propelled by the compression of the tube body 106. That is, the effective surface area of ​​the first surface 302 of the filter 102 may be approximately equal to the surface area of ​​the first surface 302 of the filter 102 that is exposed within the opening of the retaining ring 108 defined by the inner diameter 402. In some embodiments, the ratio a:v of the exposed surface area (a) of the first surface 302 of the filter 102 to the internal volume 516(v) of the tube body 106 is approximately 5 m -1 , about 6m -1 , about 7m -1 Approximately 8m -1 Approximately 9m -1 , about 10m -1 , about 11m -1 , about 12m -1 , about 13m -1 Approximately 14m -1 , about 15m -1 , about 16m -1 , about 17m -1 , about 18m -1 , about 19m -1 , about 20m -1 , about 21m -1 , about 22m -1 , about 23m -1 , about 24m -1 , about 25m -1 , about 26m -1 , about 27m -1 , about 28m -1 , about 29m -1 , about 30m -1 , about 31m -1 , about 32m -1 , about 33m -1 , about 34m -1 , about 35m -1 , or approximately 36m -1It may be any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the ratio a:v of the exposed surface area (a) of the first surface 302 of the filter 102 to the internal volume 516(v) of the tube body 106 is approximately 10 m -1 ~about 25m -1 This is possible. Additionally or alternatively, in some embodiments, the ratio a:v of the exposed surface area (a) of the first surface 302 of the filter 102 to the internal volume 516(v) of the tube body 106 is approximately 15 m -1 ~about 20m -1 This is possible. Additionally or alternatively, in some embodiments, the ratio a:v of the exposed surface area (a) of the first surface 302 of the filter 102 to the internal volume 516(v) of the tube body 106 is approximately 17 m -1 It is possible.

[0090] Figures 8A to 8C illustrate exemplary steps of attaching the retaining ring 108 to the tube body 106 and exemplary steps of closing the open end 502 using the dispensing cap 104, according to the present disclosure. Figure 8A shows the closed end 514 of the tube body 106 being inserted into the opening of the retaining ring 108. As shown in Figure 8B, the retaining ring 108 may be engaged and / or secured by a plurality of teeth 508. In this non-limiting embodiment, the retaining ring 108 is held in place relative to the tube body 106 by the plurality of teeth 508. The plurality of teeth 508 can prevent the retaining ring 108 from moving upward or downward relative to the tube body 106, while allowing the retaining ring 108 to rotate around the longitudinal axis of the tube body 106. The cap body 224 can be moved, for example, by bending and / or folding the arm 218, to attach to and / or close the open end 502 of the tube body 106, as indicated by the arrow in Figure 8B. Figure 8C shows the filter tube assembly 100 with the retaining ring 108 and the cap body 224 attached to the tube body 106.

[0091] [6. Travel caps and other components for long-term fluid storage] Figures 9A and 9B show exemplary travel caps 902 attached to a tube body 106 according to the present disclosure. Figure 9A shows a perspective view of the travel cap 902 attached to the tube body 106. Figure 9B shows an exploded view of the travel cap 902 and the tube body 106. Figure 9C shows a side view of the travel cap 902 attached to the tube body 106. Figure 9D shows a cross-sectional side view of the travel cap 902 attached to the tube body 106. In some embodiments, the travel cap 902 may be used to cover the open end 502. The travel cap 902 may be used, for example, when the tube body 106 is used to store a buffer solution before filtering a sample using the filter tube assembly 100. The travel cap 902 can prevent and / or suppress the leakage, release, evaporation, etc., of the fluid contained within the tube body 106. By closing the open end 502 of the tube body 106 with the travel cap 902, the loss of fluid, such as buffer solution, held within the tube body 106 can be suppressed and / or prevented. The travel cap 902 includes a thumb tab 904. The thumb tab 904 may include a groove 906. The thumb tab 904 may provide leverage for removing the travel cap 902 from the tube body 106. The groove 906 of the thumb tab 904 may provide additional gripping force, allowing for easy removal of the travel cap 902 from the tube body 106.

[0092] The travel cap 902 may include a collar 908 capable of forming a fluid-tight barrier (e.g., a plug seal) to a portion of the open end 502 of the tube body 106. The collar 908 may extend from the cap top 912. The collar 908 may contact the inner circumference of the tube body 106 at the open end 502, thereby forming a fluid-tight seal. When the travel cap 902 is attached to the tube body 106, the upper part of the tube body 106 (e.g., the open end 502) may be sandwiched between the collar 908 and the travel cap wall 910. The travel cap 902 may include a recess 914 extending along at least a portion of the circumference of the inner surface of the travel cap 902, the recess 914 may engage with the snap-fit ​​ridge 504 of the tube body 106. When the travel cap 902 is attached to the tube body 106, the travel cap 902 may abut against the flange 506 of the tube body 106. In some embodiments, the thickness of the cap top 912 may be substantially the same as at least a portion of the travel cap wall 910.

[0093] In alternative embodiments to those described with reference to Figures 9A and 9B, the travel cap 902 may include a threaded portion that can interact with the threaded portion of the tube body 106. In such embodiments, the user can secure the travel cap 902 to the tube body 106 by rotating the travel cap 902 relative to the tube body 106 to engage (screw) the threaded portions. In such embodiments, the travel cap 902 may not snap-fit ​​to the tube body 106.

[0094] In some embodiments, particularly when the fluid (e.g., buffer solution) is stored in the tube body 106 for an extended period (e.g., several days, weeks, months, and / or years) before the filter tube assembly 100 is used to filter the sample-containing fluid, a seal may be fitted to the open end 502 to prevent evaporation or contamination of the buffer solution in the tube body 106. Exemplary examples include foil heat-sealed seals. Alternatively, induction sealing may be used to join the seal to the open end 502 of the tube body 106.

[0095] [B. A filter tube assembly comprising a disc filter and a tube body and dispensing cap as a single component.] Embodiments of filter tube assemblies according to this disclosure may include one-piece assemblies. For example, in some embodiments, the filter tube assembly may include a dispense cap and a tube body molded as a single part, for example, as a single piece of plastic. Figures 10A to 10D show an exemplary filter tube assembly according to one embodiment of this disclosure, which may be used to prepare a sample for a molecular assay, in which the dispense cap 1002 and the tube body 1004 are single parts. Figure 10A shows a perspective view of the filter tube assembly 1000. Figure 10B shows a side view of the filter tube assembly 1000. Figure 10C shows a perspective view of the filter tube assembly 1000, with an arrow indicating the movement of the dispense cap 1002 to close the open end 1018 of the tube body 1004. Figure 10D shows a cross-sectional side view of the filter tube assembly 1000. The filter tube assembly 1000 can propel a predetermined volume (amount) of filtered sample-containing fluid in one, two, three, or four or fewer compressions, in accordance with the present disclosure (for example, with reference to filter tube assembly 100). It is understood that the filter tube assembly 1000 may include various features described herein, including those described with reference to filter tube assembly 100.

[0096] The filter tube assembly 1000 may include an arm 1006 connecting the dispense cap 1002 to the tube body 1004. In some embodiments, the filter tube assembly 1000 includes two arms. In some embodiments, the filter tube assembly 1000 includes only one arm. The arm 1006 may include a notch 1008, which may allow the arm 1006 to bend and / or fold. The dispense cap 1002 may include a collar 1010, a cap flange 1012, an opening 1016, a flow path 1024, a transition region 1026, and a ridge 1028. The dispense cap 1002 may engage with a retaining ring 108 and a filter 102, so that the filter 102 is positioned between the internal volume 1022 of the tube body 1004 and the flow path 1024. The ridge 1028 may extend along at least a portion of the inner circumference of the dispense cap 1002. The ridge 1028 may engage with the groove 406 of the retaining ring 108, thereby securing the retaining ring 108 and the filter 102 within the dispense cap 1002. The flow path 1024 and / or transition region 1026 may be sized and shaped according to this disclosure (see, for example, the flow path 204 and transition zone 206). In some embodiments, the dispense cap 1002 may include a buttress 1036 positioned around the nozzle 1034, which may support and / or stabilize the nozzle 1034. In some embodiments, the dispense cap 1002 may not include such a buttress.

[0097] The tube body 1004 may include a tube flange 1014, a filling line 510, an open end 1018, a closed end 1020, a wall 1030, and an internal volume 1022. The tube body 1004 and / or internal volume 1022 may be sized and / or shaped according to this disclosure (see, for example, the tube body 106 and / or internal volume 516).

[0098] The material contained in the tube body 1004 may be at least partially optically transparent, for example, at least partially transparent to visible light. In some embodiments, the transparency of the material of the tube body 1004 may allow the user to visually inspect the amount (volume) of sample-containing fluid and / or buffer held in the internal volume 1022. The filling line 510 may indicate to the user whether a sufficient amount of sample-containing fluid and / or buffer is present in the internal volume 1022 of the tube body 1004. In some embodiments, as shown in Figures 10A to 10D, the filling line 510 may be a raised feature molded into the wall 1030 of the tube body 1004. In some embodiments, the filling line 510 may be a recess molded into the wall 1030. In some embodiments, the filling line 510 may be printed on the wall 1030 using, for example, ink or marking material. In some embodiments, the tube body 1004 may include a plurality of filling lines 510. In such embodiments, each filling line 510 may indicate a different volume (amount). When the filter tube assembly 1000 is oriented with the dispense cap 1002 facing upward and the closed end 1020 of the tube body 1004 facing downward, the user may be able to compare the vertical position of the upper surface of the buffer and / or sample-containing fluid in the internal volume 1022 with the position of the filling line 510. In some embodiments, the filling line 510 may indicate whether or not the minimum volume of sample-containing fluid required to perform the molecular assay is present. In some embodiments where the buffer fluid is stored in the internal volume 1022 for several days, weeks, months, and / or years, the filling line 510 may indicate whether or not the buffer volume has been lost beyond a threshold indicated by the filling line 510 due to evaporation, leakage, and / or escape from, for example, the tube body 1004.In some embodiments, where the fluid (e.g., buffer solution) is stored in the tube body 1004 for an extended period (e.g., several days, weeks, months, and / or years) before the filter tube assembly 1000 is used to filter the sample-containing fluid, a seal may be fitted to the open end 1018 to form a fluid-tight barrier, thereby preventing evaporation or contamination of the buffer solution in the tube body 1004. In exemplary embodiments, the seal may be a foil heat-sealed seal or an induction seal. Alternatively, in some embodiments, the filter tube assembly 1000 may include a travel cap capable of forming a fluid-tight barrier between itself and the open end 1018 of the tube body 1004.

[0099] In some embodiments, the internal volume 1022 of the tube body 1004 can be reduced to propel the sample-containing fluid from the filter tube assembly 1000 to a test device for performing, for example, a molecular assay (e.g., diffusion amplification). The reduction of the internal volume 1022 can be achieved in several ways. In the first embodiment shown in Figures 10A to 10D, the material of the tube body 1004 is flexible enough to allow a user to compress the wall 1030 of the tube body 1004 to propel one or more streams of filtered sample-containing fluid through the opening 1016 of the dispense cap 1002 to the test device. The one or more streams may be a continuous stream of fluid propelled through the opening 1016. The flexibility may result from a combination of the thickness 1032 of the wall 1030 and the modulus of elasticity (e.g., Young's modulus) of the material contained in the tube body 1004. For example, the thickness 1032 of the wall 1030 may be less than a portion of the thickness of the dispense cap 1002. The combination of the wall thickness 1032 of the wall 1030 and the material of the tube body 1004 can be selected so that the tube body 1004 can be compressed by the user. In a second embodiment, the tube body 1004 may have a thin-walled portion in the wall 1030 extending axially and / or radially, which provides a hinge point to the tube body 1004. At this hinge point, the wall 1030 can bend, while the other portion of the wall 1030 is thicker and / or stiffer. In this case, the user can compress the tube body 1004, and the tube body 1004 flexes at the thin-walled hinge point, reducing the internal volume 1022 and forcing the sample-containing fluid through the filter 102 and the channel 1024 and out of the opening 1016 of the dispense cap 1002, but the wall 1030 is not thin enough to flex completely. Other configurations are also possible, in which a stream or other volume of the sample-containing fluid is propelled from the tube body 1004 through the dispense cap 1002.In other embodiments, the tube body 1004 may not require compression or squeezing to dispense fluid from the container (filter tube assembly 1000), and may dispense fluid droplets when the filter tube assembly 1000 is inverted.

[0100] In some embodiments, the thickness of the material at the closed end 1020 may be equal to or greater than the thickness 1032 of the wall 1030. In some embodiments, the thickness 1032 of the wall 1030 may be about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.50 mm, about 0.55 mm, about 0.60 mm, about 0.65 mm, about 0.70 mm, about 0.75 mm, about 0.80 mm, about 0.85 mm, about 0.90 mm, about 0.95 mm, or about 1.0 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 1032 may be approximately 0.40 mm to approximately 0.60 mm. Additionally or alternatively, in some embodiments, the thickness 1032 may be approximately 0.45 mm to approximately 0.55 mm. Additionally or alternatively, in some embodiments, the thickness 1032 may be approximately 0.51 mm.

[0101] The dispense cap 1002 may include a collar 1010 capable of forming a fluid-tight barrier against a portion of the open end 1018 of the tube body 1004. The collar 1010 may contact the inner circumference of the open end 1018 of the tube body 1004, thereby forming a fluid-tight seal. When the dispense cap 1002 is attached to the open end 1018 of the tube body 1004, the collar 1010 may deflect the wall of the tube body 1004 near the open end 1018 in an outward direction. When the dispense cap 1002 is attached to the open end 1018 of the tube body 1004, the cap flange 1012 of the dispense cap 1002 may abut the tube flange 1014 of the tube body 1004. In some embodiments, the cap flange 1012 need not abut the tube flange 1014 to confirm that an effective seal is formed between the dispense cap 1002 and the tube body 1004.

[0102] [C. Filter tube assembly comprising a cup filter and a tube body and a dispense cap as a single component] As described above, embodiments of the filter tube assembly according to the present disclosure may include an assembly comprising a tube body and a dispense cap as a single component. For example, in some embodiments, the filter tube assembly may comprise a dispense cap and a tube body that may be molded as a single piece of plastic. FIGS. 11A through 11D illustrate an exemplary filter tube assembly that may be used to prepare a sample for a molecular assay according to an embodiment of the present disclosure. FIG. 11A shows an exemplary filter tube assembly 1100 in a perspective view. FIG. 11B shows the exemplary filter tube assembly 1100 in a side view. FIG. 11C shows the filter tube assembly 1100 in an exploded side view. FIG. 11D shows the filter tube assembly 1100 in a perspective view with the dispense cap 1102 not fixed to the tube body 1104.

[0103] The filter tube assembly 1100 may comprise a filter 1108 (e.g., a cup filter), a dispense cap 1102, and a tube body 1104. In some embodiments, the filter tube assembly 1100 may comprise an arm 1106 connecting the tube body 1104 to the dispense cap 1102. The filter tube assembly 1100 may be used to prepare a sample-containing fluid for use in molecular assays. The tube body 1104 may be capable of holding a fluid, such as a buffer or a sample-containing fluid. When open, the tube body 1104 may be capable of receiving a sample, such as a swab from which a sample has been taken. When the dispense cap 1102 is attached to the tube body 1104 and the tube body 1104 is compressed, the filter tube assembly 1100 may propel the sample-containing fluid from the internal volume of the tube body 1104 through the filter 1108 and out of the dispense cap 1102.

[0104] In some examples, the filter tube assembly 1100 is capable of propelling (spraying) filtered sample-containing fluid from a dispense cap 1102 in one or more streams (for example, at a significantly higher dispensing rate than a dropper). In some embodiments of the filter tube assembly according to this disclosure, the dispense cap is configured to propel a continuous stream of filtered sample-containing fluid through the opening during each compression of the tube body. Advantageously, embodiments of the filter tube assembly can deliver large volumes of filtered sample-containing fluid rapidly and accurately through the opening with minimal user intervention. This minimizes the risk of the filtered sample-containing fluid being exposed to, degraded, or damaged by environmental or user-derived contaminants before it is delivered to the test device on which the molecular assay is performed. In one non-limiting embodiment described below, the filter tube assembly according to this disclosure is configured to propel approximately 2.5 to approximately 3.0 mL of filtered sample-containing fluid through the opening as a continuous stream during one, two, three, or four compressions of the tube body. In one embodiment, a total volume of filtered sample-containing fluid of approximately 2.5 to 3.0 mL is propelled through the opening during two or fewer compressions of the tube body. Each compression may result in multiple continuous streams of fluid being propelled through the opening. Alternatively, compression of the tube body may result in a single continuous stream of fluid being propelled through the opening.

[0105] When filtered using the filter tube assembly 1100, the sample-containing fluid is prepared for use in molecular assays. For example, the filter tube assembly 1100 may be capable of removing by filtration certain molecules and / or particles that may interfere with the molecular assay. Exemplary inhibitors that can be removed by embodiments of the filter tube assembly described herein include proteins (blood-based and non-blood-based), carbohydrates (e.g., mucins), immunoglobulins, cells and cell debris, host microbiota, human genomic DNA (hugDNA), and salts. Advantageously, embodiments of the filter tube assembly according to this disclosure can remove these and other inhibitors, thereby significantly improving assay sensitivity, shortening DNA and RNA amplification times, and in some cases preventing test failures caused by excess inhibitors in the crude matrix.

[0106] Molecular assays may require relatively large volumes of sample-containing liquid compared to other assay types (e.g., immunoassays). Therefore, it may be desirable that the filter tube assembly 1100 according to the embodiments of this disclosure be able to rapidly and / or easily dispense the total volume as presented herein. Since the filter tube assembly 1100 is capable of propelling the filtered sample-containing fluid out of the dispensing cap, filtration is relatively rapid (e.g., within a few seconds of compressing the tube body 1104, or immediately in response to the compression of the tube body 1104). In some embodiments, the filter tube assembly 1100 can release the total volume of filtered sample-containing fluid by compressing the tube body 1104 two or fewer times. This compression can be provided by the user compressing the tube body 1104. In some other embodiments, the filter tube assembly 1100 can release the total volume of filtered sample-containing fluid by compressing the tube body 1104 one, two, three, or four times.

[0107] In some embodiments, the filter tube assembly 1100 contains approximately 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, and 3.6 mL of filtered fluid. , about 3.7mL, about 3.8mL, about 3.9mL, about 4.0mL, about 4.1mL, about 4.2mL, about 4.3mL, about 4.4mL, about 4.5mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5. 0mL, about 5.1mL, about 5.2mL, about 5.3mL, about 5.4mL, about 5.5mL, about 5.6mL, about 5.7mL, about 5.8mL, about 5.9mL, about 6.0mL, about 6.1mL, about 6.2mL, about 6.3mL, about 6.4mL, about 6.5mL, about 6.6mL, about 6.7mL, about 6.8mL, about 6.9mL, about 7.0mL, about 7.1mL, about 7.2mL, about 7.3mL, about 7.4mL, about 7.5mL, about 7.6mL, about 7.7m L, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8.5mL, about 8.6mL, about 8.7mL, about 8.8mL, about 8.9mL, about 9.0mL, about 9. The filter tube assembly 1100 can dispense a total amount of 1 mL, approximately 9.2 mL, approximately 9.3 mL, approximately 9.4 mL, approximately 9.5 mL, approximately 9.6 mL, approximately 9.7 mL, approximately 9.8 mL, approximately 9.9 mL, or approximately 10.0 mL, or a total amount of any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the filter tube assembly 1100 can dispense a total amount of approximately 2 mL to approximately 4 mL of filtered fluid. Additionally or alternatively, in some embodiments, the filter tube assembly 1100 can dispense a total amount of approximately 2.5 mL to approximately 3 mL of filtered fluid.

[0108] In some embodiments, during a single compression of the tube body 1104, the filter tube assembly 1100 filters out approximately 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL, 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, and 3. The filter tube assembly 1100 can dispense a total amount of 1 mL, approximately 3.2 mL, approximately 3.3 mL, approximately 3.4 mL, approximately 3.5 mL, approximately 3.6 mL, approximately 3.7 mL, approximately 3.8 mL, approximately 3.9 mL, approximately 4.0 mL, approximately 4.1 mL, approximately 4.2 mL, approximately 4.3 mL, approximately 4.4 mL, approximately 4.5 mL, approximately 4.6 mL, approximately 4.7 mL, approximately 4.8 mL, approximately 4.9 mL, or approximately 5.0 mL, or a total amount of any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the filter tube assembly 1100 can dispense a total amount of approximately 0.5 mL to approximately 2 mL of filtered fluid per compression of the tube body 1104. Additionally or alternatively, in some embodiments, the filter tube assembly 1100 is capable of dispensing a total amount of filtered fluid of approximately 0.5 mL to approximately 1.5 mL per compression of the tube body 1104.

[0109] [1. Dispensing cap] Figures 12A to 12D show a dispense cap 1102 included in a filter tube assembly 1100 according to one embodiment of the present disclosure. Figure 12A shows a perspective top view (perspective view from above) of the dispense cap 1102. Figure 12B shows a side view of the dispense cap 1102. Figure 12C shows a perspective bottom view (perspective view from below) of the dispense cap 1102. Figure 12D shows a cross-sectional side view of the dispense cap 1102.

[0110] The dispensing cap 1102 may include an opening 1202, a flow path 1204, a filter cavity 1216, an internal space 1212, a proximal end 1208, a nozzle 1206, a cap flange 12010, a cap body 1220, a collar 1222, and a retaining bump 1238. The flow path 1204 may include a transition region 1214.

[0111] The flow path 1204 may be a hollow space within the dispense cap 1102, for example, a hollow space within the nozzle 1206 of the dispense cap 1102. The opening 1202 may be a hole at the distal end of the nozzle 1206. The flow path 1204 may allow one or more propulsion streams of the sample-containing fluid (e.g., filtered sample-containing fluid) to flow out of the dispense cap 1102. In some embodiments, the diameter of the opening 1202 may be approximately 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the opening 1202 may have a diameter of about 2 mm to about 4 mm. Additionally or alternatively, in some embodiments, the opening 1202 may have a diameter of about 2.8 mm to about 3.2 mm. The filter cavity 1216 may be a space capable of receiving and holding the filter 1108 according to embodiments of the present disclosure. When the filter 1108 is positioned within the dispense cap 1102, the inner wall of the filter cavity 1216 may be in contact with the filter 1108. When the filter 1108 is positioned for use as part of a filter tube assembly 1100, it may be in contact with the distal surface 1218 of the filter cavity 1216. The transition region 1214 may be positioned in the vicinity of the filter cavity 1216. The diameter of the filter cavity 1216 may be about the same as or smaller than the outer diameter of the filter 1108.

[0112] The retaining bump 1238 may be positioned near the filter cavity 1216. The retaining bump 1238 may prevent or block the filter 1108 from detaching from the filter cavity 1216. The retaining bump 1238 may act to fix the filter 1108 positioned within the filter cavity 1216 by, for example, contacting, engaging with, or partially abutting a portion of the filter 1108. Alternatively, the retaining bump 1238 may be separated from the filter 1108 when the filter 1108 is seated within the filter cavity 1216 and abutting its distal end 1218. In such embodiments, the retaining bump 1238 may contact the filter 1108 when the filter 1108 is moving away from the distal surface 1218. It may be desirable to include the retaining bump 1238, especially for highly viscous sample fluids. The dispense cap 1102 may include one, two, three, four, five, six, or more retaining bumps 1238. In some embodiments, the dispense cap 1102 may include three retaining bumps 1238. The retaining bumps 1238 may be positioned along the circumference of the internal space 1212 (for example, on the inner surface of the dispense cap 1102). In embodiments where two or more retaining bumps are present, each retaining bump 1238 may be spaced apart from the other retaining bumps 1238. Alternatively, the dispense cap 1102 may include a single retaining bump 1238 extending along the circumference of the internal space 1212. The retaining bump 1238 may extend from the inner surface of the dispense cap 1102. The distance that the retaining bump 1238 extends from the inner surface of the dispense cap 1102 may be approximately 0.10 mm, approximately 0.11 mm, approximately 0.12 mm, approximately 0.13 mm, approximately 0.14 mm, approximately 0.15 mm, approximately 0.16 mm, approximately 0.17 mm, approximately 0.18 mm, approximately 0.19 mm, approximately 0.20 mm, approximately 0.21 mm, approximately 0.22 mm, approximately 0.23 mm, approximately 0.24 mm, approximately 0.25 mm, approximately 0.26 mm, approximately 0.27 mm, approximately 0.28 mm, approximately 0.29 mm, or approximately 0.30 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values.Additionally or alternatively, the distance the retaining bump 1238 extends from the inner surface of the dispensing cap 1102 may be approximately 0.15 mm to approximately 0.25 mm. Additionally or alternatively, the distance the retaining bump 1238 extends from the inner surface of the dispensing cap 1102 may be approximately 0.20 mm to approximately 0.25 mm. Additionally or alternatively, the distance the retaining bump 1238 extends from the inner surface of the dispensing cap 1102 may be approximately 0.21 mm to approximately 0.23 mm. The retaining bump 1238 also allows the filter 1108 (particularly the cup filter wall 1302) to flexibly pass over the retaining bump 1238 during assembly. It may be desirable that the retaining bump 1238 be shaped and sized such that the filter 1108 can pass over the retaining bump 1238 during assembly, but cannot pass over the retaining bump 1238 in the reverse direction during use of the filter tube assembly 1100. The retaining bump 1238 may be configured to hold the filter 1108 when a force is applied to the filter 1108 in the opposite direction to the direction of the fluid flow out through the opening 1202 during dispensing (for example, the force applied to the filter 1108 between the first and second compressions of the filter tube assembly 1100). In some cases, after compression of the filter tube assembly 1100, fluid and / or air may be drawn in the opposite direction to the fluid flow through the filter tube assembly 1100. The retaining bump 1238 may be configured to prevent or prevent the filter 1108 from falling out even when the filter 1108 is subjected to such fluid and / or air forces.

[0113] The transition region 1214 may provide a volume through which the sample-containing fluid can be propelled out of the filter 1108. The transition region 1214 has a larger diameter than the rest of the flow path 1204. Therefore, since the transition region 1214 does not significantly narrow the diameter of the flow path, it can reduce the back pressure acting on the filter 1108 (i.e., the pressure inside the tube body 1104 when the tube body 1104 is compressed). By reducing the pressure acting on the filter 1108, the transition region 1214 can reduce the risk of the filter 1108 breaking, rupturing, and / or slipping when the tube body 1104 is compressed. In some embodiments, the diameter of the transition region 1214 may be approximately 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the transition region 1214 may have a diameter of approximately 8 mm to 12 mm. Additionally or alternatively, in some embodiments, the transition region 1214 may have a diameter of approximately 10 mm.

[0114] The nozzle 1206 may extend away from the cap body 1220. The inner surface of the nozzle 1206 may define a portion of the flow path 1204. The diameter of the flow path 1024 may decrease as the flow path 1024 extends toward the opening 1202. In some embodiments, the dispensing cap 1102 may include a buttress positioned around the nozzle 1206, which may support and / or stabilize the nozzle 1206. In some embodiments, the dispensing cap 1102 may not include such a buttress.

[0115] The arm 1106 may extend from the cap flange 1210 to the tube body 1104. The arm 1106 may be bendable and / or foldable to allow the dispense cap 1102 to approach the open end of the tube body 1104. The material of the dispense cap 1102 and / or the dimensions of the arm 1106 may affect the ability of the arm 1106 to fold and / or bend. In some embodiments, the arm 1106 may include a notch. The notch may allow the arm 1106 to bend and / or fold. As described above, the dispense cap 1102, the arm 1106 and the tube body 1104 may be cast as a single piece, for example, as a single piece of plastic.

[0116] The cap body 1220 may include an internal space 1212. The cap body 1220 may include a collar 1222. The collar 1222 may be sized and shaped to engage with the open end 1406 of the tube body 1104. The outer diameter of the collar 1222 may decrease as the collar 1222 extends from the vicinity of the cap flange 1210 to the proximal end 1208. Such a decrease in diameter may allow the collar 1222 to transmit a greater force to the inner surface of the tube body 1104 as the collar 1222 is further inserted into the tube body 1104 (for example, when the dispensing cap 1102 is secured to the tube body 1104 before use of the filter tube assembly 1100 for filtering a sample-containing fluid). For example, the diameter 1230 may be equal to or greater than the diameter 1232. In some embodiments, the diameter 1230 may be approximately 10 mm, approximately 11 mm, approximately 12 mm, approximately 13 mm, approximately 14 mm, approximately 15 mm, approximately 16 mm, approximately 17 mm, approximately 18 mm, approximately 19 mm, approximately 20 mm, approximately 21 mm, approximately 22 mm, approximately 23 mm, approximately 24 mm, or approximately 25 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the diameter 1230 may be approximately 15 mm to approximately 20 mm. Additionally or alternatively, in some embodiments, the diameter 1230 may be approximately 16 mm to approximately 19 mm. Additionally or alternatively, in some embodiments, the diameter 1230 may be approximately 17 mm to approximately 18 mm. In some embodiments, the diameter 1232 may be approximately 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, or 25 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used.Additionally or alternatively, in some embodiments, the diameter 1232 may be approximately 14 mm to approximately 19 mm. Additionally or alternatively, in some embodiments, the diameter 1232 may be approximately 15 mm to approximately 18 mm. Additionally or alternatively, in some embodiments, the diameter 1232 may be approximately 16 mm to approximately 17 mm. In some embodiments, diameter 1232 may be approximately 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm smaller than diameter 123, or by any value or range within any of these ranges or numerical values, or by any range bounded by any of these ranges or numerical values. Additionally or alternatively, diameter 1232 may be approximately 0.5 mm to 1.5 mm smaller than diameter 1230. Additionally or alternatively, diameter 1232 may be approximately 0.8 mm to 1.2 mm smaller than diameter 1230. Additionally or alternatively, diameter 1232 may be approximately 0.9 mm to 1.1 mm smaller than diameter 1230. Additionally or alternatively, diameter 1232 may be approximately 1.0 mm smaller than diameter 1230.

[0117] The collar 1222 may optionally include a ridge 1228. The ridge 1228 may engage with a feature portion of the tube body 1104 according to this disclosure. The ridge 1228 may extend over at least a portion of the outer circumference of the collar 1222. Referring to Figure 12B, the ridge 1228 is defined by an upward sloping surface 1240, a apex 1242, and a downward sloping surface 1244. In some embodiments, the angle of the downward sloping surface 1244 of the ridge 1228 may be smaller than the angle of the upward sloping surface 1240 of the ridge 1228. The difference in angle between the upward sloping surface 1240 and the downward sloping surface 1244 may allow the force required to attach the dispense cap 1102 to the tube body 1104 to be smaller than the force required to remove the dispense cap 1102 from the tube body 1104. The height of the apex 1242 can be selected to be small enough not to damage the plug seal between the dispense cap 1102 and the tube body 1104.

[0118] As the collar 1222 extends from the cap flange 1210 to the proximal end 1208 of the dispense cap 1102, the wall thickness of the collar 1222 may decrease. For example, the distal collar thickness 1226 may be equal to or greater than the proximal collar thickness 1224. In embodiments where the distal collar thickness 1226 is greater than the proximal collar thickness 1224, the collar 1222 may be able to flex near the proximal end 1208, which may allow the collar 1222 to fit into the open end of the tube body 1104. A taper on the collar 1222 may help the user form an interference seal with the tube body 1104 having a gradually increasing force. In some embodiments, the gradually increasing force is configured to provide an ergonomic user experience, for example, ensuring efficient, reliable, and / or comfortable movement when the user connects the dispense cap 1102 to the tube body 1104. The proximal color thickness 1224 may be approximately 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the proximal color thickness 1224 may be approximately 0.5 to 1.0 mm.The distal collar thickness 1226 is approximately 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm. It may be approximately 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, or 4.0 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the distal collar thickness 1226 may be approximately 2.5 mm to approximately 3.5 mm. Additionally or alternatively, in some embodiments, the distal collar thickness 1226 may be approximately 3.0 mm to approximately 3.3 mm. Additionally or alternatively, in some embodiments, the distal collar thickness 1226 may be approximately 3.1 mm to approximately 3.2 mm.

[0119] In some embodiments, the outer diameter of the collar 1222 may decrease as it extends from the cap flange 1210. For example, the distal collar diameter 1236 may be larger than the proximal collar diameter 1234. Such a decrease in the outer diameter of the collar 1222 may allow the dispense cap 1102 to be secured to the tube body 1104 by interference fit. Such a decrease in the outer diameter of the collar 1222 may allow the dispense cap 1102 to be attached to the tube body 1104 with less force than would be possible if the outer diameter of the collar 1222 were not reduced.In some embodiments, the distal collar diameter 1236 is 10.0mm, 10.1mm, 10.2mm, 10.3mm, 10.4mm, 10.5mm, 10.6mm, 10.7mm, 10.8mm, 10.9mm, 11.0mm, 11.1mm, 11.2mm, 11.3mm, 11.4mm, 11.5mm, 11.6mm, 11.7mm, 11.8mm, 11.9mm, 12.0mm, 12.1mm, 12.2mm, 12.3mm, 12.4mm, 12.5mm, 12.6mm, 12.7mm, 12. 8mm, 12.9mm, 13.0mm, 13.1mm, 13.2mm, 13.3mm, 13.4mm, 13.5mm, 13.6mm, 13.7mm, 13.8mm, 13.9mm, 14.0mm, 14.1mm, 14.2mm, 14.3mm, 14 .4mm, 14.5mm, 14.6mm, 14.7mm, 14.8mm, 14.9mm, 15.0mm, 15.1mm, 15.2mm, 15.3mm, 15.4mm, 15.5mm, 15.6mm, 15.7mm, 15.8mm, 15.9mm, 16 .0mm, 16.1mm, 16.2mm, 16.3mm, 16.4mm, 16.5mm, 16.6mm, 16.7mm, 16.8mm, 16.9mm, 17.0mm, 17.1mm, 17.2mm, 17.3mm, 17.4mm, 17.5mm, 1 7.6mm, 17.7mm, 17.8mm, 17.9mm, 18.0mm, 18.1mm, 18.2mm, 18.3mm, 18.4mm, 18.5mm, 18.6mm, 18.7mm, 18.8mm, 18.9mm, 19.0mm, 19.1mm, 1 It may be 9.2mm, 19.3mm, 19.4mm, 19.5mm, 19.6mm, 19.7mm, 19.8mm, 19.9mm, 20.0mm, 20.1mm, 20.2mm, 20.3mm, 20.4mm, 20.5mm, 20.6mm, 20.7mm, 20.8mm, 20.9mm, or 21.0mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the distal collar diameter 1236 may be approximately 16.5mm to approximately 18.5mm.Additionally or alternatively, in some embodiments, the distal collar diameter 1236 may be approximately 17.0 mm to approximately 18.0 mm. In some embodiments, the proximal collar diameter 1234 may be 9.0 mm, 9.1 mm, 9.2 mm, 9.3 mm, 9.4 mm, 9.5 mm, 9.6 mm, 9.7 mm, 9.8 mm, 9.9 mm, 10.0 mm, 10.1 mm, 10.2 mm, 10.3 mm, 10.4 mm, 10.5 mm, 10.6 mm, 10.7 mm, 10.8 mm, 10.9 mm, 11.0 mm, 11.1 mm, 11.2 mm, 11.3 mm, 11.4 mm, 11.5 mm, 11.6 mm, 11.7 mm, 11.8 mm, 11. 9mm, 12.0mm, 12.1mm, 12.2mm, 12.3mm, 12.4mm, 12.5mm, 12.6mm, 12.7mm, 12.8mm, 12.9mm, 13.0mm, 13.1mm, 13.2mm, 13.3mm, 13.4mm, 1 3.5mm, 13.6mm, 13.7mm, 13.8mm, 13.9mm, 14.0mm, 14.1mm, 14.2mm, 14.3mm, 14.4mm, 14.5mm, 14.6mm, 14.7mm, 14.8mm, 14.9mm, 15.0mm, 15.1mm, 15.2mm, 15.3mm, 15.4mm, 15.5mm, 15.6mm, 15.7mm, 15.8mm, 15.9mm, 16.0mm, 16.1mm, 16.2mm, 16.3mm, 16.4mm, 16.5mm, 16.6m m, 16.7mm, 16.8mm, 16.9mm, 17.0mm, 17.1mm, 17.2mm, 17.3mm, 17.4mm, 17.5mm, 17.6mm, 17.7mm, 17.8mm, 17.9mm, 18.0mm, 18.1mm, 18.2 The values ​​may be mm, 18.3 mm, 18.4 mm, 18.5 mm, 18.6 mm, 18.7 mm, 18.8 mm, 18.9 mm, 19.0 mm, 19.1 mm, 19.2 mm, 19.3 mm, 19.4 mm, 19.5 mm, 19.6 mm, 19.7 mm, 19.8 mm, 19.9 mm, or 20.0 mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used.Additionally or alternatively, in some embodiments, the proximal collar diameter 1234 may be approximately 15.5 mm to approximately 17.5 mm. Additionally or alternatively, in some embodiments, the proximal collar diameter 1234 may be approximately 16.0 mm to approximately 17.0 mm. In some embodiments, the difference between the proximal collar diameter 1234 and the distal collar diameter 1236 may be 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. In some embodiments, the difference between the proximal collar diameter 1234 and the distal collar diameter 1236 is 0.5 mm to 1.5 mm. In some embodiments, the difference between the proximal collar diameter 1234 and the distal collar diameter 1236 is 1 mm.

[0120] In some embodiments, the dispense cap 1102 may include plastic. In some embodiments, the plastic may be polypropylene, high-density polyethylene, or linear low-density polyethylene (LLDPE). The dimensions and material of the dispense cap 1102 may be preferably selected such that when the tube body 1104 of the filter tube assembly 1100 is compressed, a portion of the dispense cap 1102 (e.g., the nozzle 1206, the cap flange 1210, and / or the cap body 1220) is substantially undeformed or deformed only minimally. The dimensions and material of the dispense cap 1102 may be preferably selected such that when the tube body 1104 of the filter tube assembly 1100 is compressed, a portion of the dispense cap 1102 (e.g., the collar 1222) is deformable. In several examples, the Young's modulus of the material of the dispense cap 1102 was approximately 200 MPa, approximately 210 MPa, approximately 220 MPa, approximately 230 MPa, approximately 240 MPa, approximately 250 MPa, approximately 260 MPa, approximately 270 MPa, approximately 280 MPa, approximately 290 MPa, approximately 300 MPa, approximately 310 MPa, approximately 320 MPa, approximately 330 MPa, approximately 340 MPa, approximately 350 MPa, approximately 360 MPa, approximately 370 MPa, approximately 380 MPa, approximately 390 MPa, approximately 400 MPa, approximately 410 MPa, approximately 420 MPa, approximately 430 MPa, approximately 440 MPa, approximately 450 MPa, approximately 460 MPa, approximately 470 MPa, approximately 480 MPa, approximately 490 MPa, approximately 500 MPa, and approximately 51 MPa. 0 MPa, approx. 520 MPa, approx. 530 MPa, approx. 540 MPa, approx. 550 MPa, approx. 560 MPa, approx. 570 MPa, approx. 580 MPa, approx. 590 MPa, approx. 600 MPa, approx. 610 MPa, approx. 620 MPa, approx. 630 MPa, approx. 640 MPa, approx. 650 MPa, approx. 660 MPa, approx. 670 MPa, approx. 680 MPa, approx. 690 MPa, approx. 700 MPa, approx. 710 MPa, approx. 720 MPa, approx. 730 MPa, approx. 740 MPa, approx. 750 MPa, approx. 760 MPa, approx. 770 MPa, approx. 780 MPa, approx. 790 MPa, approx. 800 MPa, approx. 810 MPa, approx. 820 MPa, approx. 830 MPa, approx. 840 MPa, approx. 850 MPa, approx. 860 MPa,Approximately 870 MPa, approximately 880 MPa, approximately 890 MPa, approximately 900 MPa, approximately 910 MPa, approximately 920 MPa, approximately 930 MPa, approximately 940 MPa, approximately 950 MPa, approximately 960 MPa, approximately 970 MPa, approximately 980 MPa, approximately 990 MPa, approximately 1000 MPa, approximately 1010 MPa, approximately 1020 MPa, approximately 1030 MPa, approximately 1040 MPa, approximately 1050 MPa, approximately 1060 MPa, approximately 1070 MPa, approximately 1080 MPa, approximately 1090 MPa, approximately 1100 MPa, approximately 1110 MPa, approximately 1120 MPa, approximately 1130 MPa, approximately 1140 MPa, approximately 1150 MPa, 1160MPa, 1170MPa, 1180MPa, 1190MPa, 1200MPa, 1210MPa, 1220MPa, 1230MPa, 1240MPa, 1250MPa, 1260MPa, 1270MPa, 1280MPa, 1290MPa a, about 1300MPa, about 1310MPa, about 1320MPa, about 1330MPa, about 1340MPa, about 1350MPa, about 1360MPa, about 1370MPa, about 1380MPa, about 1390MPa, about 1400MPa, about 1410MPa, about 1420MPa, about 1430M Pa, approximately 1440MPa, approximately 1450MPa, approximately 1460MPa, approximately 1470MPa, approximately 1480MPa, approximately 1490MPa, approximately 1500MPa, approximately 1510MPa, approximately 1520MPa, approximately 1530MPa, approximately 1540MPa, approximately 1550MPa, approximately 1560MPa, approximately 157 0MPa, approximately 1580MPa, approximately 1590MPa, approximately 1600MPa, approximately 1610MPa, approximately 1620MPa, approximately 1630MPa, approximately 1640MPa, approximately 1650MPa, approximately 1660MPa, approximately 1670MPa, approximately 1680MPa, approximately 1690MPa, approximately 1700MPa, approximately 17 10MPa, approximately 1720MPa, approximately 1730MPa, approximately 1740MPa, approximately 1750MPa, approximately 1760MPa, approximately 1770MPa, approximately 1780MPa, approximately 1790MPa, approximately 1800MPa, approximately 1810MPa, approximately 1820MPa, approximately 1830MPa, approximately 1840MPa, approximately 1850MPa, approximately 1860MPa, approximately 1870MPa, approximately 1880MPa, approximately 1890MPa, approximately 1900MPa, approximately 1910MPa, approximately 1920MPa, approximately 1930MPa, approximately 1940MPa, approximately 1950MPa, approximately 1960MPa, approximately 1970MPa, approximately 1980MPa,It may be approximately 1990 MPa, approximately 2000 MPa, approximately 2010 MPa, approximately 2020 MPa, approximately 2030 MPa, approximately 2040 MPa, approximately 2050 MPa, approximately 2060 MPa, approximately 2070 MPa, approximately 2080 MPa, approximately 2090 MPa, approximately 3000 MPa, approximately 3010 MPa, approximately 3020 MPa, approximately 3030 MPa, approximately 3040 MPa, approximately 3050 MPa, approximately 3060 MPa, approximately 3070 MPa, approximately 3080 MPa, approximately 3090 MPa, or approximately 4000 MPa, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 1102 may be approximately 200 MPa to approximately 700 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 1102 may be approximately 200 MPa to approximately 300 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the dispense cap 1102 may be approximately 400 MPa to approximately 500 MPa.

[0121] The cap flange 1210 may abut against the surface of the tube body 1104 according to this disclosure. In some embodiments, the cap flange 1210 does not need to abut against the tube flange 1410 to ensure that an effective seal is formed between the dispense cap 1102 and the tube body 1104. In such embodiments, there may be sufficient interference fit to form an effective seal between the dispense cap 1102 and the tube body 1104 without contact between the cap flange 1210 and the tube flange 1410.

[0122] [2. Cup filter] In some embodiments, the filter included in the filter tube assembly 1100 may be a cup filter. The cup filter 1108 is an example of a cup filter. As previously mentioned, the filter cavity 1216 may be a space capable of receiving and holding the filter 1108. The filter 1108 may be received in the filter cavity 1216 of the dispense cap 1102. The cup filter may be cast as a single part, for example, as a single piece of material. The cup filter may have a flat surface from which a wall extends, the wall may define a recessed space, and the overall shape of the cup filter may resemble the shape of a cup. Figures 13A to 13D show illustrations of the filter 1108. Figure 13A shows a perspective bottom view (perspective view from below) of the filter 1108. Figure 13B shows a perspective top view (perspective view from above) of the filter 1108. Figure 13C shows a cross-sectional side view of the filter 1108. Figure 13D shows a bottom view of filter 1108. Filter 1108 may include a cup filter wall 1302 having a filter height 1310 and a wall thickness 1312. Filter 1108 may also include a proximal surface 1304 and a distal surface 1306. The distal surface 1306 may have an outer diameter 1308. The distance between the distal surface 1306 and the proximal surface 1304 may define the filter depth 1314. Filter 1108 may also include an inner wall corner 1318, an outer wall corner 1320, a recessed space corner 1322, and a distal corner 1324. Filter 1108 also includes a recessed space 1326 having an inner diameter 1316. Each of the inner wall corner 1318, outer wall corner 1320, recessed space corner 1322, and distal corner 1324 may be sharp, obtuse, and / or rounded. The cup filter may be used with any suitable filter tube assembly according to this disclosure.

[0123] In certain embodiments, the outer diameter 1308 of the filter 1108 may be approximately 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, or 30 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the outer diameter 1308 may be approximately 12 mm to 16 mm. Additionally or alternatively, in some embodiments, the outer diameter 1308 may be approximately 14 mm.

[0124] In a particular embodiment, the surface area of ​​the distal surface 1306 is approximately 50 mm². 2 , about 60mm 2 , about 70mm 2 , about 80mm 2 , about 90mm 2 Approximately 100mm 2 , about 110mm 2 , about 120mm 2 , about 130mm 2 , about 140mm 2 , about 150mm 2 , about 160mm 2 , about 170mm 2 , about 180mm 2 , about 190mm 2 , about 200mm 2 , about 210mm 2 , about 220mm 2 , about 230mm 2 , about 240mm 2 , about 250mm 2 , about 260mm 2 , about 270mm 2 , about 280mm 2 , about 290mm 2 , about 300mm 2 , about 310mm 2 , about 320mm 2 , about 330mm2 , about 340mm 2 , about 350mm 2 , about 360mm 2 , about 370mm 2 , about 380mm 2 , about 390mm 2 , or approximately 400mm 2 It may be any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the surface area of ​​the distal surface 1306 is approximately 100 mm². 2 ~about 200mm 2 It is possible. Additionally or alternatively, in some embodiments, the surface area of ​​the distal surface 1306 is approximately 140 mm². 2 ~approx. 160mm 2 It is possible.

[0125] In certain embodiments, the inner diameter 1316 of the filter 1108 may be approximately 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, or 25 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the inner diameter 1306 may be approximately 8 mm to 12 mm. Additionally or alternatively, in some embodiments, the inner diameter 1306 may be approximately 10 mm.

[0126] In a particular embodiment, the surface area of ​​the proximal surface 1304 is approximately 30 mm². 2 Approximately 40mm 2 Approximately 50mm 2 , about 60mm 2 , about 70mm 2 , about 80mm2 , about 90mm 2 Approximately 100mm 2 , about 110mm 2 , about 120mm 2 , about 130mm 2 , about 140mm 2 , about 150mm 2 , about 160mm 2 , about 170mm 2 , about 180mm 2 , about 190mm 2 , or approximately 200 mm 2 It may be any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the surface area of ​​the proximal surface 1304 is approximately 50 mm². 2 ~approximately 100mm 2 This is possible. Additionally or alternatively, in some embodiments, the surface area of ​​the proximal surface 1304 is approximately 70 mm². 2 ~about 90mm 2 It is possible.

[0127] In a particular embodiment, the filter depth 1314 of the filter 1108 may be approximately 0.1 mm, approximately 0.2 mm, approximately 0.3 mm, approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, approximately 1.0 mm, approximately 1.1 mm, approximately 1.2 mm, approximately 1.3 mm, approximately 1.4 mm, approximately 1.5 mm, approximately 1.6 mm, approximately 1.7 mm, approximately 1.8 mm, approximately 1.9 mm, approximately 2.0 mm, approximately 2.1 mm, approximately 2.2 mm, approximately 2.3 mm, approximately 2.4 mm, approximately 2.5 mm, approximately 2.6 mm, approximately 2.7 mm, approximately 2.8 mm, approximately 2.9 mm, or approximately 3.0 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the filter depth 1314 may be approximately 0.8 mm to approximately 1.2 mm. Additionally or alternatively, in some embodiments, the filter depth 1314 may be approximately 0.8 mm to approximately 1.2 mm. Additionally or alternatively, in some embodiments, the filter depth 1314 may be approximately 1 mm. Additionally or alternatively, in some embodiments, the filter depth 1314 may be approximately 1.3 mm to approximately 1.8 mm. Additionally or alternatively, in some embodiments, the filter depth 1314 may be approximately 1.6 mm.

[0128] The cup filter wall 1302 may engage with the inner circumference of the dispense cap 1102. Additionally or alternatively, the cup filter wall 1302 may engage with the ridge on the inner circumference of the dispense cap 1102. The cup filter wall 1302 may be sufficiently large (i.e., the filter height 1310 may be sufficiently long (high)) so that the contact area (and therefore the friction area) between the cup filter wall 1302 and the surface of the dispense cap 1102 in the internal space 1212 is sufficient to prevent and / or restrain the movement of the filter 1108 when the tube body 1104 is compressed. In one embodiment, the filter 1108 is held in place within the dispense cap 1102 based solely on interference fit. Advantageously, the ability (function) to hold the filter 1108 in place within the dispense cap 1102 without adhesive or other chemical bonding can reduce or eliminate the introduction of confounding factors during sample filtration and dispensing. The cup filter wall 1302 may provide structural support to the portion of the filter 1108 between the proximal surface 1304 and the distal surface 1306, so as not to fold over. In certain embodiments, the filter height 1310 of the filter 1108 is approximately 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3. It may be 2mm, approximately 3.3mm, approximately 3.4mm, approximately 3.5mm, approximately 3.6mm, approximately 3.7mm, approximately 3.8mm, approximately 3.9mm, approximately 4.0mm, approximately 4.1mm, approximately 4.2mm, approximately 4.3mm, approximately 4.4mm, or approximately 4.5mm, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the filter height 1310 may be approximately 3.6mm to approximately 4.0mm.Additionally or alternatively, in some embodiments, the filter height 1310 may be approximately 3.8 mm to approximately 3.9 mm. The filter height 1310 may be several times greater than the filter depth 1314. In some embodiments, the filter height 1310 may be 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 times the filter depth 1314, or a multiple of any value or range inside any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, multiples of values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the filter height 1310 may be approximately 1.5 to approximately 3.5 times the filter depth 1314. Additionally or alternatively, in some embodiments, the filter height 1310 may be about 2 to 3 times the filter depth 1314. Additionally or alternatively, in some embodiments, the filter height 1310 may be about 2.3 to 2.6 times the filter depth 1314.

[0129] In certain embodiments, the wall thickness 1312 of the filter 1108 may be approximately 1.1 mm, approximately 1.2 mm, approximately 1.3 mm, approximately 1.4 mm, approximately 1.5 mm, approximately 1.6 mm, approximately 1.7 mm, approximately 1.8 mm, approximately 1.9 mm, approximately 2.0 mm, approximately 2.1 mm, approximately 2.2 mm, approximately 2.3 mm, approximately 2.4 mm, approximately 2.5 mm, approximately 2.6 mm, approximately 2.7 mm, approximately 2.8 mm, approximately 2.9 mm, or approximately 3.0 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. Additionally or alternatively, in some embodiments, the wall thickness 1312 may be approximately 1.6 mm to approximately 2.4 mm. Additionally or alternatively, in some embodiments, the wall thickness 1312 may be approximately 1.8 mm to approximately 2.2 mm. Additionally or alternatively, in some embodiments, the wall thickness 1312 may be approximately 1.9 mm to approximately 2.1 mm.

[0130] The filter 1108 comprises a porous material. This porous material may contain sized and shaped pores or spaces that allow fluid to pass from the proximal surface 1304 to the distal surface 1306, while preventing some particles from passing through. The size of these pores may affect which particles are filtered (removed by filtration) as the sample-containing fluid passes through the filter 1108. The pore size may be desirable to be small enough to remove particles that could interfere with the molecular assay. The pore size may be desirable to be large enough to allow sufficient volume and velocity of fluid flow through the filter 1108 and / or to reduce the risk of the filter 1108 becoming clogged with particles. The sizes of the pores in porous materials (e.g., average pore diameter) are approximately 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 45 μm, 50 μm, 55 μm, 60 μm, 65 μm, 70 μm, 75 μm, 80 μm, 85 μm, 90 μm, and 95 μm. The size may be approximately μm, about 100 μm, about 110 μm, about 120 μm, about 130 μm, about 140 μm, about 150 μm, about 160 μm, about 170 μm, about 180 μm, about 190 μm, or about 200 μm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 5 μm to about 25 μm. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 10 μm to about 20 μm. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 50 μm to about 120 μm. Additionally or alternatively, in some embodiments, the size of the pore may be approximately 20 μm to about 25 μm. Additionally or alternatively, in some embodiments, the size of the pores may be approximately 5 μm to approximately 15 μm. The porous material may contain multiple winding pathways. In some embodiments, the porous material may be hydrophobic.In some embodiments, the porous material may include polyethylene (PE), polypropylene (PP), or polytetrafluoroethylene (PTFE). In some embodiments, the porous material may be hydrophilic. In some embodiments, the porous material may include glass fibers or meltblown polypropylene (PP). In some embodiments, the porous material may be a sintered porous material. In some embodiments, the porous material may be sintered PE.

[0131] In one non-limiting embodiment, the filter 1108 comprises a plurality of membranes, at least one of which has different properties (e.g., different pore sizes and / or different hydrophobic / hydrophilic properties). The plurality of membranes may be arranged in a stacked configuration. One membrane may be positioned near the proximal surface 1304 and function as a prefilter. The membrane functioning as a prefilter may have pores of a size and / or shape for holding larger particles, while one or more downstream membranes may have pores of a size and / or shape for holding smaller particles. In one non-limiting embodiment, a first tube assembly is configured to dispense a first sample-containing fluid intended to be tested for a first analyte and comprises a filter comprising a single membrane. A second tube assembly is configured to dispense a second sample-containing fluid intended to be tested for a second analyte different from the first analyte and comprises a filter comprising two membranes. The second sample-containing fluid may contain a crude matrix for which a two-stage filtration method is optimal for the first sample-containing fluid.

[0132] [3. Tube body] Figures 14A to 14D show a tube body 1104 included in a filter tube assembly 1100 according to one embodiment of the present disclosure. A dispense cap 1102 and an arm 1106 are also shown. Figure 14A shows a side view of the tube body 1104. Figure 14B shows a cross-sectional side view of the tube body 1104. Figure 14C shows a perspective view of the tube body 1104. Figure 14D shows a plan view of the tube body 1104. The tube body 1104 may include an open end 1406, a closed end 1408, a tube flange 1410, a tube wall 1416 having a thickness 1412, and an internal volume 1414. The tube body 1104 may optionally include a base region 1404 and a neck region 1402 including a ridge 1418.

[0133] The internal volume 1414 is capable of holding fluids such as sample-containing fluid. In some embodiments, the fluid is a buffer to which the sample is added, forming the sample-containing fluid. The dispense cap 1102 may be positioned on the open end 1406 of the tube body 1104, and the internal space 1212 of the dispense cap 1102 may be fluidly connected to the internal volume 1414, allowing the filter 1108 to be in contact with the sample-containing fluid when the tube body 1104 is compressed and / or the filter tube assembly 1100 is inverted.In several embodiments, the internal volume 1414 in an uncompressed state was approximately 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, 3.7 mL, 3.8 mL, 3.9 mL, 4.0 mL, 4.1 mL, 4.2 mL, 4.3 mL, 4.4 mL, and 4. 5mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5.0mL, about 5.1mL, about 5.2mL, about 5.3mL, about 5.4mL, about 5.5mL, about 5.6mL, about 5.7mL, about 5.8mL, about 5.9mL, Approximately 6.0mL, approximately 6.1mL, approximately 6.2mL, approximately 6.3mL, approximately 6.4mL, approximately 6.5mL, approximately 6.6mL, approximately 6.7mL, approximately 6.8mL, approximately 6.9mL, approximately 7.0mL, approximately 7.1mL, approximately 7.2mL, approximately 7.3mL, approximately 7.4m L, about 7.5mL, about 7.6mL, about 7.7mL, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8.5mL, about 8.6mL, about 8.7mL, about 8.8mL, about 8 .9mL, about 9.0mL, about 9.1mL, about 9.2mL, about 9.3mL, about 9.4mL, about 9.5mL, about 9.6mL, about 9.7mL, about 9.8mL, about 9.9mL, about 10.0mL, about 10.1mL, about 10.2mL, about 10. It may be 3 mL, approximately 10.4 mL, approximately 10.5 mL, approximately 10.6 mL, approximately 10.7 mL, approximately 10.8 mL, approximately 10.9 mL, approximately 11 mL, approximately 11.5 mL, approximately 12 mL, approximately 12.5 mL, approximately 13 mL, approximately 13.5 mL, approximately 14 mL, approximately 14.5 mL, or approximately 15 mL, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the internal volume 1414 may be approximately 4 mL to approximately 6 mL in an uncompressed state. Additionally or alternatively, in some embodiments, the internal volume 1414 may be approximately 5 mL. Additionally or alternatively, in some embodiments, the internal volume 1414 may be approximately 6.7 mL.In several embodiments, the tube body 1104 contained approximately 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL, 1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 2.1 mL, 2.2 mL, 2.3 mL, 2.4 mL, 2.5 mL, 2.6 mL, 2.7 mL, 2.8 mL, 2.9 mL, 3.0 mL, 3.1 mL, 3.2 mL, 3.3 mL, 3.4 mL, 3.5 mL, 3.6 mL, and 3.7 mL of the sample-containing fluid. L, about 3.8mL, about 3.9mL, about 4.0mL, about 4.1mL, about 4.2mL, about 4.3mL, about 4.4mL, about 4.5mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5.0mL, about 5.1mL, about 5.2mL, about 5.3mL , about 5.4mL, about 5.5mL, about 5.6mL, about 5.7mL, about 5.8mL, about 5.9mL, about 6.0mL, about 6.1mL, about 6.2mL, about 6.3mL, about 6.4mL, about 6.5mL, about 6.6mL, about 6.7mL, about 6.8mL, about 6.9mL, about 7.0mL, about 7.1mL, about 7.2mL, about 7.3mL, about 7.4mL, about 7.5mL, about 7.6mL, about 7.7mL, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8.5mL, about 8 .6mL, approx. 8.7mL, approx. 8.8mL, approx. 8.9mL, approx. 9.0mL, approx. 9.1mL, approx. 9.2mL, approx. 9.3mL, approx. 9.4mL, approx. It is possible to hold 10.2 mL, approximately 10.3 mL, approximately 10.4 mL, approximately 10.5 mL, approximately 10.6 mL, approximately 10.7 mL, approximately 10.8 mL, approximately 10.9 mL, approximately 11 mL, approximately 11.5 mL, approximately 12 mL, approximately 12.5 mL, approximately 13 mL, approximately 13.5 mL, approximately 14 mL, approximately 14.5 mL, or approximately 15 mL, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, amounts of values ​​outside these numerical values ​​or ranges may also be used (and can be held). In one non-limiting embodiment, the tube body 1104 is capable of holding approximately 6.7 mL of sample-containing fluid.Additionally or alternatively, in some embodiments, the tube body 1104 can hold approximately 2 mL to approximately 4 mL of the sample-containing fluid. Additionally or alternatively, in some embodiments, the tube body 1104 can hold approximately 3 mL of the sample-containing fluid. In some embodiments, the tube body 1104 can hold approximately 1.0 mL, approximately 1.1 mL, approximately 1.2 mL, approximately 1.3 mL, approximately 1.4 mL, approximately 1.5 mL, approximately 1.6 mL, approximately 1.7 mL, approximately 1.8 mL, approximately 1.9 mL, approximately 2.0 mL, approximately 2.1 mL, approximately 2.2 mL, approximately 2.3 mL, approximately 2.4 mL, and approximately 2.5 mL of the headspace volume (e.g., the volume inside the tube body 1104 not occupied by the fluid when the buffer or sample-containing fluid is present inside the tube body 1104). mL, about 2.6mL, about 2.7mL, about 2.8mL, about 2.9mL, about 3.0mL, about 3.1mL, about 3.2mL, about 3.3mL, about 3.4mL, about 3.5mL, about 3.6mL, about 3.7mL, about 3.8mL, about 3.9mL, about 4. 0mL, about 4.1mL, about 4.2mL, about 4.3mL, about 4.4mL, about 4.5mL, about 4.6mL, about 4.7mL, about 4.8mL, about 4.9mL, about 5.0mL, about 5.1mL, about 5.2mL, about 5.3mL, about 5.4mL, about 5. 5mL, about 5.6mL, about 5.7mL, about 5.8mL, about 5.9mL, about 6.0mL, about 6.1mL, about 6.2mL, about 6.3mL, about 6.4mL, about 6.5mL, about 6.6mL, about 6.7mL, about 6.8mL, about 6.9mL, about 7 .0mL, about 7.1mL, about 7.2mL, about 7.3mL, about 7.4mL, about 7.5mL, about 7.6mL, about 7.7mL, about 7.8mL, about 7.9mL, about 8.0mL, about 8.1mL, about 8.2mL, about 8.3mL, about 8.4mL, about 8 This may include 0.5 mL, approximately 8.6 mL, approximately 8.7 mL, approximately 8.8 mL, approximately 8.9 mL, approximately 9.0 mL, approximately 9.1 mL, approximately 9.2 mL, approximately 9.3 mL, approximately 9.4 mL, approximately 9.5 mL, approximately 9.6 mL, approximately 9.7 mL, approximately 9.8 mL, approximately 9.9 mL, or approximately 10.0 mL, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, volumes of values ​​outside these numerical values ​​or ranges may also be used (may include).Additionally or alternatively, in some embodiments, the tube body 1104 may contain approximately 1 mL to approximately 3 mL of headspace volume. Additionally or alternatively, in some embodiments, the tube body 1104 may contain approximately 2 mL of headspace volume.

[0134] In some embodiments, the internal volume 1414 of the tube body 1104 can be reduced to propel the sample-containing fluid from the filter tube assembly 1100 to a test device for performing, for example, a molecular assay (e.g., diffusion amplification). The reduction of the internal volume 1414 can be achieved in several ways. In the embodiments shown in Figures 14A to 14D, the material of the tube body 1104 is flexible enough to allow a user to compress the wall 1416 of the tube body 1104, particularly in the base region 1404, to propel one or more streams of filtered sample-containing fluid through the opening 1202 of the dispense cap 1102 to the test device. The one or more streams may be a continuous stream of fluid propelled through the opening 1202. The flexibility may result from a combination of the thickness of the wall 1416 and the modulus of elasticity (e.g., Young's modulus) of the material contained in the tube body 1104. The combination of the wall thickness 1416 and the material of the tube body 1104 can be selected so that the tube body 1104 is compressible by the user. In a second embodiment, the tube body 1104 may have thin-walled portions in the wall 1416 extending axially and / or radially, which provide a hinge point to the tube body 1104. At this hinge point, the wall 1416 can bend, while the rest of the wall 1416 is thicker and / or stiffer. In this case, the user can compress the tube body 1104, and the tube body 1104 flexes at the thin-walled hinge point, reducing the internal volume 1414 and forcing the sample-containing fluid through the filter 1108 and the channel 1204 to exit the opening 1202 of the dispense cap 1102, but the entire wall 1416 is not thin enough to flex. Other approaches are also possible for propelling a stream or other volume of the sample-containing fluid from the tube body 1104 through the dispensing cap 1102. In other embodiments, the tube body 1104 may not require compression or squeezing to dispense fluid from the filter tube assembly 1100, and may dispense fluid droplets when the filter tube assembly 1100 is inverted.

[0135] In some embodiments, the thickness of the material of the tube body 1104 in the tube flange 1410 may be greater than or equal to the thickness 1412 of the wall 1416. In some embodiments, the thickness 1412 of the material of the closed end 1408 may be equal to or greater than the thickness 1412 of the wall 1416. In some embodiments, the thickness 1412 of the wall 1416 may be approximately 0.2 mm, approximately 0.25 mm, approximately 0.3 mm, approximately 0.35 mm, approximately 0.4 mm, approximately 0.45 mm, approximately 0.5 mm, approximately 0.55 mm, approximately 0.6 mm, approximately 0.65 mm, approximately 0.7 mm, approximately 0.75 mm, approximately 0.8 mm, approximately 0.85 mm, approximately 0.9 mm, approximately 0.95 mm, approximately 1.0 mm, approximately 1.05 mm, approximately 1.10 mm, approximately 1.15 mm, approximately 1.2 mm, or approximately 1.25 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 1412 may be approximately 0.2 mm to approximately 1.0 mm. Additionally or alternatively, in some embodiments, the thickness 1412 may be about 0.50 mm to about 1.0 mm. Additionally or alternatively, in some embodiments, the thickness 1412 may be about 0.60 mm to about 0.90 mm. Additionally or alternatively, in some embodiments, the thickness 1412 may be about 0.70 mm to about 0.80 mm. Additionally or alternatively, in some embodiments, the thickness 1412 may be about 0.75 mm.

[0136] The neck region 1402 and the base region 1404 allow for variations in the thickness of the tube body 1104. In an exemplary embodiment, the base region 1404 may be sized and shaped such that the height of any liquid contained within the tube body 1104 reaches a suitable height so that a swab head can be immersed in the liquid. In an exemplary embodiment, the base region 1404 may have an inner diameter of 12-13 mm and a height of 28-29 mm, while the neck region 1402 may have an inner diameter of 16-17 mm and a height of 7-8 mm. In such an embodiment, the tube body 1104 may hold 2 mL of buffer solution and allow an industry-standard sample collection swab to be fully immersed when received by the tube body 1104. In another embodiment, the base region 1404 may be sized and shaped so that the tube body 1104 can be placed and held in a standard tube rack. The neck region 1402 can be sized and shaped to accommodate a dispense cap 1102 that is large enough to allow for a suitable filter surface area (e.g., the filter surface area of ​​filter 1108).

[0137] The ridge 1418 may be positioned within the neck region 1402, as shown in Figures 14B and 14C. Referring to Figure 14B, the ridge 1418 is defined by an upward sloping surface 1420, a apex 1422, and a downward sloping surface 1424. In some embodiments, the angle of the upward sloping surface 1420 of the ridge 1418 may be smaller than the angle of the downward sloping surface 1424 of the ridge 1418. The difference in angle between the upward sloping surface 1420 and the downward sloping surface 1424 may allow the force required to attach the dispense cap 1102 to the tube body 1104 to be less than the force required to remove the dispense cap 1102 from the tube body 1104. The height of the apex 1422 may be selected to be small enough not to damage the plug seal between the dispense cap 1102 and the tube body 1104.

[0138] In some embodiments, the tube body 1104 may include plastic. In some embodiments, the plastic may be polyethylene. In some embodiments, the plastic may be low-density polyethylene (LDPE). In some embodiments, the plastic may be linear low-density polyethylene (LLDPE). Advantageously, the tube body 1104 containing LLDPE may not crack even after multiple squeezing (compression) cycles. Advantageously, the tube body 1104 containing LLDPE allows for a wall thickness 1412 to be sufficiently thick for manufacturing while simultaneously allowing for a relatively low squeezing force (compression force) required to compress the filter tube assembly 1100. Advantageously, the tube body 1104 containing LLDPE allows for a higher force of interference fit to be applied to the dispense cap 1102 while requiring a similar or lower force from the user to secure the dispense cap 1102 to the tube body 1104. Conversely, a greater interference fit force can be advantageous because a stronger seal can be formed. Advantageously, embodiments of tube bodies having a greater interference fit force, including LLDPE according to this disclosure, can provide a more robust tube assembly that is less sensitive to non-circularity, molding tolerances, or damage within the sealing area.In several embodiments, the Young's modulus of the material of the tube body 1104 was approximately 70 MPa, 80 MPa, 90 MPa, 100 MPa, 110 MPa, 120 MPa, 130 MPa, 140 MPa, 150 MPa, 160 MPa, 170 MPa, 180 MPa, 190 MPa, 200 MPa, 210 MPa, 220 MPa, 230 MPa, 240 MPa, 250 MPa, 260 MPa, 270 MPa, 280 MPa, 290 MPa, and 300 MPa. a, about 310MPa, about 320MPa, about 330MPa, about 340MPa, about 350MPa, about 360MPa, about 370MPa, about 380MPa, about 390MPa, about 400MPa, about 410MPa, about 420MPa, about 430MPa, about 4 40MPa, approximately 450MPa, approximately 460MPa, approximately 470MPa, approximately 480MPa, approximately 490MPa, approximately 500MPa, approximately 510MPa, approximately 520MPa, approximately 530MPa, approximately 540MPa, approximately 550MPa, approximately 560MPa, approximately 570MPa Approximately 580 MPa, approximately 590 MPa, approximately 600 MPa, approximately 610 MPa, approximately 620 MPa, approximately 630 MPa, approximately 640 MPa, approximately 650 MPa, approximately 660 MPa, approximately 670 MPa, approximately 680 MPa, approximately 690 MPa, approximately 700 MPa, approximately 710 MPa, approximately 720 MPa, approximately 730 MPa, approximately 740 MPa, approximately 750 MPa, approximately 760 MPa, approximately 770 MPa, approximately 780 MPa, approximately 790 MPa, approximately 800 MPa, approximately 810 MPa, approximately 820 MPa, approximately 830 MPa, approximately 840 MPa, It may be approximately 850 MPa, approximately 860 MPa, approximately 870 MPa, approximately 880 MPa, approximately 890 MPa, approximately 900 MPa, approximately 910 MPa, approximately 920 MPa, approximately 930 MPa, approximately 940 MPa, approximately 950 MPa, approximately 960 MPa, approximately 970 MPa, approximately 980 MPa, approximately 990 MPa, or approximately 1 MPa, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 1104 may be approximately 200 Pa to approximately 700 MPa.Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 1104 may be about 200 Pa to about 300 MPa. Additionally or alternatively, in some embodiments, the Young's modulus of the material of the tube body 1104 may be about 400 Pa to about 500 MPa.

[0139] The material contained in the tube body 1104 may be optically transparent, for example, transparent to visible light. In some embodiments, the transparency of the material of the tube body 1104 may allow the user to visually inspect the amount (volume) of sample-containing fluid and / or buffer held in the internal volume 1414. In some embodiments, a filling line may be provided to indicate to the user whether a sufficient amount of sample-containing fluid and / or buffer is present in the internal volume 1414 of the tube body 1104. In some embodiments, the filling line may be a raised feature molded into the wall 1416. In some embodiments, the filling line may be a recess molded into the wall 1416. In some embodiments, the filling line may be printed on the wall 1416 using, for example, ink or other marking material. In some embodiments, the tube body 1104 may include multiple filling lines. In such embodiments, each filling line may indicate a different volume (amount). When the filter tube assembly 1100 is oriented with its open end 1406 facing upward and the closed end 1408 of the tube body 1104 facing downward, the user may be able to compare the vertical position of the upper surface of the buffer and / or sample-containing fluid in the internal volume 1414 with respect to the position of the filling line. In some embodiments, the filling line may indicate whether or not the minimum volume of sample-containing fluid required to perform the molecular assay is present. In some embodiments where the buffer fluid is stored in the internal volume 1414 for several days, weeks, months, and / or years, the filling line may indicate whether or not the buffer volume has been lost beyond a threshold indicated by the filling line due to evaporation, leakage, and / or escape from, for example, the tube body 1104.

[0140] The dispense cap 1102 may be positioned on and / or above the open end 1406. The collar 1222 of the dispense cap 1102 may engage with the inside of the tube body 1104, for example, the inside of the neck region 1402. When the dispense cap 1102 is fixed to the open end 1406 of the tube body 1104, the ridge 1228 of the collar 1222 may be configured to engage with the ridge 1418 of the neck region 1402. The engagement of the ridge 1228 with the ridge 1418 may prevent and / or detour of the dispense cap 1102 from detaching from the open end 1406 of the tube body 1104. The seal between the collar 1222 and the neck region 1402 may ensure that there is no or substantially no leakage of the sample fluid from the filter tube assembly 1100. The seal between the collar 1222 and the neck region 1402 can ensure that the maximum amount of fluid is guided toward the filter 1108 when the filter tube assembly 1100 is inverted and / or compressed. Securing the dispense cap 1102 to the neck region 1402 of the tube body 1104 first requires applying sufficient force to the top of the dispense cap 1102 to push the collar 1222 into the open end 1406 of the tube body 1104. As continuous pressure is applied to the dispense cap 1102, the ridge 1228 slides over the ridge 1418. Ridges 1228 and 1418 are slidable relative to each other, and the user can confirm, by touch and / or hearing, the presence of a seal (e.g., the plug seal of assembly portion 1710 described with reference to Figure 17) formed between the ridges 1228 and 1418 by engagement between the dispensing cap 1102 and the open end 1406 of the tube body 1104. Tactile feedback may be particularly useful because the sound produced when the ridges 1228 and 1418 slide past each other may be attenuated due to the sound being generated inside the tube assembly 1100. The neck portion 1402 may be shaped and sized to reduce deformation of the neck portion 1402 (such as deformation to a non-circular cross-section) when the base region 1404 is compressed during fluid dispensing.Advantageously, reducing the non-circularity of the neck portion 1402 may help maintain the plug seal within the assembly portion 1710 during fluid dispensing.

[0141] When the dispense cap 1102 is positioned on and / or above the open end 1406, the flange 1210 of the dispense cap 1102 may contact the tube flange 1410. Contact between the cap flange 1210 and the tube flange 1410 may prevent the dispense cap 1102 from moving further toward the closed end 1408 of the tube body 1104. Contact of the cap flange 1210 may provide a tactile response to the user when securing the dispense cap 1102 to the closed end 1408 of the tube body 1104.

[0142] [4. Seal] In some embodiments, particularly when buffers and / or reagents are stored in the tube body 1104 for extended periods (e.g., days, weeks, months, and / or years) before the filter tube assembly 1100 is used to filter sample-containing fluids, a seal may be fitted to the open end of the tube body 1104. Figures 15A and 15B illustrate such seals. Figure 15A shows a filter tube assembly 1100 with a seal 1502. Figure 15B is a top view of the seal 1502. The seal 1502 can cover the open end 1406 of the tube body 1104, as shown in Figure 15A, thereby preventing evaporation, contamination, etc., of any buffers and / or reagents contained within the tube body 1104. The seal 1502 can form a fluid-tight barrier between the internal volume 1414 of the tube body 1104 and the outside. In exemplary embodiments, the seal 1502 may be a foil heat-sealed seal. The seal 1502 can be heat-pressed onto the tube flange 1410 to form a seal. Alternatively, induction sealing can be used to join the seal 1502 to the tube flange 1419. Other joining methods can also be appropriately implemented. For example, the seal 1502 can be joined to the tube flange 1410 using an adhesive. The seal 1502 may include a cover portion 1504 and a tab portion 1506. The cover portion 1504 may cover the open end 1406 of the tube body 1104. The tab portion 1506 may be grasped and pulled by the user to allow the seal 1502 to be removed from the tube body 1104. Advantageously, the seal 1502 can be removed from the tube body 1104 with minimal risk of user contact with or contamination of any buffers and / or reagents contained within the tube body 1104.

[0143] [5. Assembly] Figures 16A to 17 show cross-sectional views of the filter tube assembly 1100, illustrating the interaction between the dispense cap 1102, the tube body 1104, and the filter 1108. Figure 16A shows a cross-sectional side view of the filter tube assembly 1100, illustrating the insertion of the filter 1108 into the dispense cap 1102. Figure 16B shows a cross-sectional side view of the filter tube assembly 1100, illustrating the state in which the filter 1108 is positioned within the dispense cap 1102. Figure 16C shows a cross-sectional side view of the dispense cap 1102 with the filter 1108 positioned inside, illustrating the path of fluid flow through the dispense cap 1102. Figure 17 shows a cross-sectional side view of the filter tube assembly 1100, illustrating the attachment of the dispense cap 1102 to the open end 1406 of the tube body 1104, and includes an inset illustrating the interaction between the collar 1222 and the neck region 1402.

[0144] As shown in Figures 16A and 16B, the filter 1108 can be positioned within the dispense cap 1102 such that its distal surface 1306 abuts against the distal surface 1218 of the dispense cap 1102. The distal surface 1218 may contact the distal surface 1306, thereby preventing the filter 1108 from moving further toward the opening 1202 of the dispense cap 1102. The outer diameter 1308 of the filter 1108 may be approximately equal to or slightly larger than the diameter of the filter cavity 1216 of the dispense cap 1102. Therefore, when the filter 1108 is positioned within the dispense cap 1102, it can fit snugly into the filter cavity 1216. For example, the filter 1108 may engage with a portion 1606 of the inner wall of the dispense cap 1102 by interference fit. The fitting of the filter 1108 can substantially prevent and / or restrict the movement of the filter 1108 within the dispense cap 1102 when the user compresses the tube body 1104 to push the sample-containing fluid through the filter 1108 and out of the dispense cap 1102.

[0145] The dashed arrow in Figure 16C indicates the direction of fluid flow through the dispense cap 1102 when the tube body 1104 of the filter tube assembly 1100 is compressed (for example, the distal direction away from the proximal end 1208 of the dispense cap 1102). When the tube body 1104 of the filter tube assembly 1100 is compressed, the sample-containing fluid can flow out from the internal space 1212 and / or internal volume 1414 (which is fluidically connected) through the filter 1108, through the flow path 1204 (including the transition region 1214, the intermediate portion 1604, and the distal portion 1602), and out through the opening 1202.

[0146] As described above, the transition region 1214 can reduce the back pressure acting on the filter 1108 (i.e., the higher pressure in the internal space 1212 relative to the pressure in the flow path 1204). The transition region 1214 provides a space having a diameter that is not excessively small but slightly smaller than the outer diameter 1308 of the filter 1108. In some embodiments, the outer diameter 1308 of the filter 1108 may be about 1.05 times, 1.10 times, 1.15 times, 1.20 times, 1.25 times, 1.30 times, 1.35 times, 1.40 times, 1.45 times, 1.50 times, 1.55 times, 1.60 times, 1.65 times, 1.70 times, 1.75 times, 1.80 times, 1.85 times, 1.90 times, 1.95 times, or about 2.00 times larger than the diameter of the transition zone 1214, or about 1.60 times, 1.65 times, 1.70 times, 1.75 times, 1.80 times, 1.85 times, 1.90 times, 1.95 times, or about 2.00 times larger, or may be a multiple of any value or range inside any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, multiples of values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the outer diameter 1308 of the filter 1108 may be approximately 1.2 to 1.6 times the diameter of the transition region 1214. Additionally or alternatively, in some embodiments, the outer diameter 1308 of the filter 1108 may be approximately 1.3 to 1.5 times the diameter of the transition region 1214. Additionally or alternatively, in some embodiments, the outer diameter 1308 of the filter 1108 may be approximately 1.35 to 1.45 times the diameter of the transition region 1214. Additionally or alternatively, in some embodiments, the outer diameter 1308 of the filter 1108 may be approximately 1.4 times the diameter of the transition region 1214.

[0147] The shape and / or dimensions of the distal portion 1602 and the intermediate portion 1604 of the flow path 1204 may also affect the pressure applied to the filter 1108. The inner surface of the dispense cap 1102 defining the intermediate portion 1604 (referred to as the curved portion 1608) may preferably include a gentle curve so that the diameter of the flow path 1204 does not decrease abruptly from the transition region 1214 to the distal portion 1602. Gradually changing the diameter of the flow path 1204 can ensure that there are no abrupt increases or decreases in the pressure of the sample-containing fluid. The inner wall of the dispense cap 1102 defining the distal portion 1602 may be gently sloped. In some embodiments, the diameter of the proximal portion of the distal portion 1602 (e.g., the portion adjacent to the intermediate portion 1604) is larger than the diameter of the opening 1202.

[0148] The ratio of the surface area of ​​the filter 1108 to the size of the internal volume 1414 can affect the maximum flow rate of the sample-containing fluid that flows out of the filter tube assembly 1100 when the tube body 1104 is compressed. This maximum flow rate is desirable to be sufficiently high, as described above, so that the filter tube assembly 1100 can dispense the total amount of filtered sample-containing fluid for molecular assay with only one, two, three, or four compressions of the tube body 1104. In some embodiments, the ratio a:v of the surface area (a) of the distal surface 1306 of the filter 1108 to the internal volume 1414 (v) of the tube body 1104 is approximately 15 m -1 , about 16m -1 , about 17m -1 , about 18m -1 , about 19m -1 , about 20m -1 , about 21m -1 , about 22m -1 , about 23m -1 , about 24m -1 , about 25m -1 , about 26m -1 , about 27m -1 , about 28m -1 , about 29m -1 , about 30m -1 , about 31m -1 , about 32m -1 , about 33m-1 , about 34m -1 , about 35m -1 , about 36m -1 , about 37m -1 , about 38m -1 , about 39m -1 , about 40m -1 , about 41m -1 Approximately 42m -1 , about 43m -1 , about 44m -1 , about 45m -1 , about 46m -1 Approximately 47m -1 Approximately 48m -1 Approximately 49m -1 Approximately 50m -1 , about 51m -1 , about 52m -1 , about 53m -1 Approximately 54m -1 , about 55m -1 , about 56m -1 , about 57m -1 Approximately 58m -1 Approximately 59m -1 , or approximately 60m -1 It may be any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the distal surface 1306 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 20 m -1 ~about 40m -1 This is possible. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the distal surface 1306 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 25 m -1 ~about 35m -1 This is possible. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the distal surface 1306 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 30 m -1This is possible. The maximum flow rate may be affected by the inner diameter 1316 of the filter 1108. Due to the difference in flow paths through the filter height 1310 and filter depth 1314, the fluid may pass through the surface area of ​​the proximal surface 1304 of the filter 1108 at a higher flow rate than when passing through the cup filter wall 1302. The portion of the distal surface 1218 that contacts the filter 1108 may obstruct the flow through the contact portion of the filter 1108. That is, in some embodiments, the surface area of ​​the filter 1108 available for fluid flow may be smaller than the surface area of ​​the distal surface 1306. In some embodiments, the ratio a:v of the surface area (a) of the proximal surface 1304 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 5 m -1 , about 6m -1 , about 7m -1 Approximately 8m -1 Approximately 9m -1 , about 10m -1 , about 11m -1 , about 12m -1 , about 13m -1 Approximately 14m -1 , about 15m -1 , about 16m -1 , about 17m -1 , about 18m -1 , about 19m -1 , about 20m -1 , about 21m -1 , about 22m -1 , about 23m -1 , about 24m -1 , about 25m -1 , about 26m -1 , about 27m -1 , about 28m -1 , about 29m -1 , about 30m -1 , about 31m -1 , about 32m -1 , about 33m -1 , about 34m -1 , about 35m -1 , or approximately 36m -1It may be any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside of these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the proximal surface 1304 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 10 m -1 ~about 25m -1 This is possible. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the proximal surface 1304 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 15 m -1 ~about 20m -1 This is possible. Additionally or alternatively, in some embodiments, the ratio a:v of the surface area (a) of the proximal surface 1304 of the filter 1108 to the internal volume 1414(v) of the tube body 1104 is approximately 17 m -1 It is possible.

[0149] Figure 17 shows a cross-sectional view of a filter tube assembly 1100 according to one embodiment of the present disclosure, in which a dispense cap 1102 is attached to a tube body 1104. When the dispense cap 1102 is attached to the open end 1406 of the tube body 1104, the collar 1222 may engage with the neck region 1402 to form a fluid-tight barrier. The engagement between the collar 1222 and the neck region 1402 may result in the transmission of lateral forces, as indicated by the dashed arrows. The engagement between the collar 1222 and the neck region 1402 may be an interference fit. Such an interference fit may occur in the assembly portion 1710. An interference fit in the assembly portion 1710 may form a plug seal. The force acting due to such an interference fit may depend on the material of the tube body 1104 and the material of the dispense cap 1102. The forces acting due to such interference fit may depend on the shape and / or size of the tube body 1104 and the dispense cap 1102. The proximal collar thickness 1224 being smaller than the distal collar thickness 1226 allows for greater deflection of the collar 1222 as it extends from the cap flange 1210. The collar 1222 may be shaped and sized such that the user can attach the dispense cap 1102 to the tube body 1104, and the engagement between the collar 1222 and the neck region 1402 is sufficient to prevent and / or suppress the dispense cap 1102 from coming off the open end 1406 of the tube body 1104 when the tube body 1104 is compressed by the user. The ridge 1228 of the dispense cap 1102 and the ridge 1418 of the tube body 1104 can engage with each other. The engagement of the ridges 1228 and 1418 can prevent and / or suppress the dispensing cap 1102 from coming off the open end 1406 of the tube body 1104. When the dispensing cap 1102 is attached to the tube body 1104, the proximal surface 1702 of the cap flange 1210 of the dispensing cap 1102 may come into contact with the distal surface 1704 of the tube flange 1410 of the tube body 1104.The contact between the proximal surface 1702 of the cap flange 1210 and the distal surface 1704 of the tube flange 1410 can prevent and / or restrict the movement of the dispense cap 1102 toward the closed end 1408 of the tube body 1104. As described above, in some embodiments, the cap flange 1210 does not need to contact the tube flange 1410 to ensure that an effective seal is formed between the dispense cap 1102 and the tube body 1104. In such embodiments, there may be sufficient interference fit to form an effective seal between the dispense cap 1102 and the tube body 1104 without contact between the cap flange 1210 and the tube flange 1410.

[0150] The shape, taper, and / or length of the collar 1222 may affect the force required to remove the dispense cap 1102 from the tube body 1104. Taper may mean that the thickness of the collar 1222 decreases as it moves away from the cap flange 1210, as described herein with respect to the collar 1222 (i.e., referring to Figure 12D, the proximal collar thickness 1224 may be smaller than the distal collar thickness 1226). Taper may also mean, additionally or alternatively, that the outer diameter of the collar 1222 decreases as it moves away from the cap flange 1210, as described herein with respect to the collar 1222 (i.e., referring to Figure 12D, the proximal collar diameter 1234 may be smaller than the distal collar diameter 1236). For example, reducing the taper of the collar 1222 and / or increasing the length of the collar 1222 may increase the force required to remove the dispense cap 1102 from the tube body 1104. The taper of the collar 1222, combined with the shape of the neck region 1402, can assist the user by forming an interference seal with the tube body 1104, which has a gradually increasing force. In some embodiments, the gradually increasing force is configured to provide an ergonomic user experience, for example, ensuring efficient, reliable, and / or comfortable movement when the user connects the dispense cap 1102 to the tube body 1104.

[0151] The shapes of the ridges 1228 and 1418 can affect the magnitude of the force required to attach the dispense cap 1102 to the tube body 1104, and / or the magnitude of the force required to remove the dispense cap 1102 from the tube body 1104. For example, the shape and / or size of the ridges 1228 and 1418 can be modified to increase and / or decrease the force required to attach the dispense cap 1102 to the tube body 1104, and / or the force required to remove the dispense cap 1102 from the tube body 1104. If either or both of the ridges 1228 and 1418 are relatively small (i.e., they do not extend very far from the outer surface of the collar 1222 or the inner surface of the neck region 1402, respectively), the force required to attach the dispense cap 1102 to the tube body 1104 may be relatively small. Increasing the size of either or both of the ridges 1228 and 1418 (i.e., the distance the ridge 1228 extends from the outer surface of the collar 1222, or the distance the ridge 1418 extends from the inner surface of the neck region 1402) can increase the force required to attach the dispense cap 1102 to the tube body 1104. In such embodiments, the sliding movement of the ridge 1228 over the ridge 1418 may provide the user with tactile or auditory feedback that the dispense cap 1102 is secured to the tube body 1104 and / or that a seal has been established.

[0152] In some embodiments, the force required to attach the dispense cap 1102 to the tube body 1104 may be approximately 10N, 20N, 30N, 40N, 50N, 60N, 70N, 80N, 90N, 100N, 110N, 120N, 130N, 140N, or 150N, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. In some embodiments, the force required to attach the dispense cap 1102 to the tube body 1104 may be approximately 20N to 100N. In some embodiments, the force required to attach the dispense cap 1102 to the tube body 1104 may be approximately 60N or less. In some embodiments, the force applied to attach the dispense cap 1102 to the tube body 1104 may be less than the force applied to remove the dispense cap 1102 from the tube body 1104. In some embodiments, the force applied to remove the dispense cap 1102 from the tube body 1104 may be approximately 10N, 15N, 20N, 25N, 30N, 35N, 40N, 45N, 50N, 55N, 60N, 65N, 70N, 75N, 80N, 85N, 90N, 95N, 100N, 105N, 110N, 115N, 120N, 125N, 130N, 135N, 140N, 145N, or 150N, or any value or range within any of these ranges or numbers, or any range bounded by any of these ranges or numbers. In some cases, values ​​outside these numbers or ranges may also be used. Additionally or alternatively, in some embodiments, the force applied to remove the dispense cap 1102 from the tube body 1104 may be about 10N to about 50N. Additionally or alternatively, in some embodiments, the force applied to remove the dispense cap 1102 from the tube body 1104 may be about 20N to about 40N.Additionally or alternatively, in some embodiments, the force applied to remove the dispense cap 1102 from the tube body 1104 may be about 25 N to about 35 N. Additionally or alternatively, in some embodiments, the force applied to remove the dispense cap 1102 from the tube body 1104 may be about 30 N. The force for attaching the dispense cap 1102 to the tube body 1104, and the force for removing the dispense cap 1102 from the tube body 1104, may be desirable to be sufficiently low so that the user can manually attach and / or remove the dispense cap 1102. In some embodiments, the force for attaching the dispense cap 1102 to the tube body 1104 is such that the user can attach the dispense cap 1102 to the tube body 1104 with one hand. The force required to remove the dispense cap 1102 from the tube body 1104 is sometimes desirable to be sufficiently high so that the dispense cap 1102 does not come off (dislodge) during normal use of the filter tube assembly 1100.

[0153] Figures 18A to 18D illustrate a series of steps for preparing a filter tube assembly 1100 for use in filtering a sample-containing fluid. Figure 18A shows the insertion of the filter 1108 into the dispense cap 1102. Figure 18B shows the removal of the seal 1502 from the tube body 1104. Figure 18C shows the closure of the tube body 1104 by the dispense cap 1102. Figure 18D shows the filter tube assembly 1100 ready for compression to filter the sample-containing fluid contained inside.

[0154] When preparing the filter tube assembly 1100 for use, the process (method) may optionally include inserting the filter 1108 into the dispense cap 1102, as shown in Figure 18A. The step of placing the filter 1108 into the dispense cap 1102 may be performed according to this disclosure. In some other embodiments, the filter tube assembly 1100 may be supplied to the user with the filter 1108 already positioned within the dispense cap 1102.

[0155] In embodiments where the filter tube assembly 1100 includes a seal 1502, the seal 1502 can be removed by the user. The user can remove the seal 1502, for example, by grasping the tab portion 1506 and pulling it upward as shown by the dotted arrow in Figure 18B. Once the seal 1502 is removed, the sample can be added to the tube body 1104.

[0156] After the sample is added to the tube body 1104, the tube body 1104 can be closed with the dispense cap 1102. The arm 1106 is bendable and / or foldable, allowing the user to position the dispense cap 1102 on the tube body 1104, as indicated by the dotted arrow in Figure 18C.

[0157] When the dispense cap 1102 is positioned on the tube body 1104, the user can compress the side of the tube body 1104 as indicated by the dotted arrow in Figure 18D. The user can also invert the filter tube assembly 1100 to guide the filtered sample-containing fluid produced by the filter tube assembly 1100 into a container (e.g., a test device) for receiving the filtered sample-containing fluid.

[0158] [D. Filter tube assembly comprising a cup filter and a tube body and dispense cap as separate components] As described above, embodiments of the filter tube assembly according to the present disclosure may comprise a two-part assembly. For example, in some embodiments, the filter tube assembly may include a dispense cap and a tube body, molded as separate parts. Figures 19A to 24 show an exemplary filter tube assembly 1900, according to one embodiment of the present disclosure, which may be used to prepare a sample for a molecular assay, in which the dispense cap 1902 and the tube body 1904 are separate parts. Figure 19A shows a perspective view of the filter tube assembly 1900. Figure 19B shows a side view of the filter tube assembly 1900. Figure 19C shows an exploded perspective view of the filter tube assembly 1900. Figure 19D shows a perspective view of the filter tube assembly 1900. The filter tube assembly 1900 can propel a predetermined volume of filtered sample-containing fluid in one, two, three, or four or fewer compressions, in accordance with the present disclosure (see, for example, filter tube assembly 1100). It is understood that the filter tube assembly 1900 may include various features described herein, including those described with reference to the filter tube assembly 1100. Since the dispense cap 1902 and the tube body 1904 are separate parts, they may be cast from different materials.

[0159] As shown in Figures 19A to 19D, the filter tube assembly 1900 may include a dispense cap 1902, a tube body 1904, and an arm 1906. The arm 1906 connects the dispense cap 1902 to a tethering 1910. The tethering 1910 is connectable to the tube body 1904 so that the dispense cap 1902 and the tube body 1904 remain attached even when the tube body 1904 is open. In other embodiments, the filter tube assembly 1900 may include two or more arms connecting the dispense cap 1902 to the tethering 1910. The arm 1906 may include a notch that allows the arm 1906 to bend and / or fold.

[0160] As shown in Figures 20A to 20E, the dispensing cap 1902 may include a collar 2022, an opening 2002, a flow channel 2004, a nozzle 2006, a proximal end 2008, a cap flange 2010, an internal space 2012, a transition region 2014, a filter cavity 2016, a distal surface 2018, a cap body 2020, a ridge 2028, and a retaining bump 2034. As described with respect to collar 1222, the thickness of collar 2022 may be non-uniform and may taper as it moves away from the cap flange 2010. In other words, the proximal collar thickness 2024 may be smaller than the distal collar thickness 2026. Additionally or alternatively, as described with respect to collar 1222, the diameter of collar 2022 may decrease as collar 2022 extends from cap flange 2010 to proximal end 2008 (i.e., distal collar diameter 2030 may be larger than proximal collar diameter 2032). Diameters 2030 and 2032 may be sized according to this disclosure (see, for example, diameters 1230 and 1232, respectively). Dispense cap 1902 may engage with filter 1108 according to this disclosure (as described, for example, with reference to dispense cap 1102 and Figures 16A to 16C). Channel 2004 and / or transition zone 2014 may be sized and shaped according to this disclosure (see, for example, channel 1204 and transition zone 1214). The filter 1108 (i.e., the cup filter 1108) may conform to embodiments of the present disclosure (see, for example, the description relating to Figures 13A to 13D). The retaining bump 2034 may be positioned near the filter cavity 2016. The retaining bump 2034 may, according to the present disclosure, prevent or restrain the filter 1108 from moving away from the filter cavity 2016. The ridge 2028 is defined according to the present disclosure by an upward inclined surface 2036, a vertex 2038, and a downward inclined surface 2040 (see, for example, Figure 12B).

[0161] As shown in Figures 21A to 21D, the tube body 1904 may include a tube flange 2110, an open end 2106, a closed end 2108, a tube wall 2116, an internal volume 2114, and a plurality of teeth 2120. The tube body 1904 may optionally include a base region 2104 and a neck region 2102 which may include a ridge 2118. Each of the tube body 1904, the internal volume 2114, the neck region 2102, the tube wall 2116, the ridge 2118, the closed end 2108, and the open end 2106 may be sized, shaped, made of, and / or have functions according to this disclosure (see, for example, tube body 1104). The plurality of teeth 2120 may be positioned on the outer surface of the tube body 1904. The multiple teeth 2120 may be positioned closer to the open end 2106 than to the closed end 2108. In some embodiments, the multiple teeth 2120 are positioned near the tube flange 2110. Two, three, four, or more teeth 2120 may be positioned along the circumference of the outer surface of the tube body 1904. The multiple teeth 2120 may be positioned on the outer surface of the neck region 2102 of the tube body 1904. Figures 21A to 21D show an embodiment including four teeth 2120 positioned at equal intervals along the circumference of the outer surface of the tube body 1904. The teeth 2120 may engage with the tethering 1910 of the dispense cap 1102 (see Figures 25A and 25B, which show the positioning of the tethering 1910 of the dispense cap relative to the multiple teeth 2120). The ridge 2118 is defined in accordance with this disclosure by an upward inclined surface 2122, a vertex 2124, and a downward inclined surface 2126 (see, for example, Figure 14B).

[0162] Figure 22 shows a filter tube assembly 1900 having a seal 1502. The seal 1502 may conform to the present disclosure (see, for example, Figure 15 and the description relating to filter tube assembly 1100). In exemplary embodiments, the seal 1502 may be a foil thermocompression seal. In another embodiment, induction sealing may be used to join the seal 1502 to the tube flange 2110. Alternatively, in some embodiments, the filter tube assembly 1900 may include a travel cap capable of forming a fluid-tight barrier between the open end 2106 of the tube body 1904 and the travel cap. Such a travel cap may conform to the present disclosure (see, for example, the description relating to travel cap 902).

[0163] Figure 23A shows the placement of the filter 1108 within the dispense cap 1902. The dispense cap 1902 includes an opening 2002, a flow path 2004, a nozzle 2006, a proximal end 2008, a transition region 2014, a filter cavity 2016, a cap body 2020, a distal surface 2018, and a retaining bump 2034. The filter 1108 can be positioned within the dispense cap 1902 in accordance with this disclosure (see, for example, Figures 16A and 16B and the description of the filter 1108 positioned within the dispense cap 1102). Figure 23B shows the filter 1108 positioned within the dispense cap 1902, illustrating the flow of liquid from the internal space 2012 through the filter 1108 to the flow path 2004. The opening 2002, the flow path 2004, the nozzle 2006, the distal portion 2302, the curved portion 2306, the intermediate portion 2304, and the transition region 2014 may conform to embodiments of the present disclosure (see, for example, Figure 16C and the description of the dispense cap 1102).

[0164] In some embodiments, the internal volume 2114 of the tube body 1904 may be reduced to propel the sample-containing fluid from the filter tube assembly 1900 to a test device for performing, for example, a molecular assay (e.g., diffusion amplification). The reduction of the internal volume 2114 can be achieved in several ways. In some embodiments, the material of the tube body 1904, particularly the material of the base region 2104, is flexible enough to allow a user to compress the wall 2116 of the tube body 1904 to propel one or more streams of filtered sample-containing fluid through the opening 2002 of the dispense cap 1902 to the test device. These one or more streams may be a continuous stream of fluid propelled through the opening 2002. The flexibility may result from a combination of the thickness 2112 of the wall 2116 and the modulus of elasticity (e.g., Young's modulus) of the material contained in the tube body 1904. For example, the thickness 2112 of the wall 2116 may be less than the thickness of a portion of the dispense cap 1902. The combination of the wall thickness 2112 of the wall 2116 and the material of the tube body 1904 can be selected so that the tube body 1904 can be compressed by the user. In another embodiment, the tube body 1904 may have a thin-walled portion in the wall 2116 extending axially and / or radially, which provides a hinge point to the tube body 1904. At this hinge point, the wall 2116 can bend, while the other portion of the wall 2116 is thicker and / or stiffer. In this case, the user can compress the tube body 1904, which flexes at the thin-walled hinge point, reducing the internal volume 2114 and forcing the sample-containing fluid through the filter 1108 and the flow path 2004 out of the opening 2002 of the dispense cap 1902, but the wall 2116 is not thin enough to flex completely. Other configurations are also possible, in which a stream or other volume of the sample-containing fluid is propelled from the tube body 1904 through the dispense cap 1902.In other embodiments, the tube body 1904 may not require compression or squeezing to dispense fluid from the container, and may dispense fluid droplets when the filter tube assembly 1900 is inverted.

[0165] In some embodiments, the thickness of the material of the tube body 1904 in the tube flange 2110 may be equal to or greater than the thickness 2112 of the wall 2116. In some embodiments, the thickness 2112 of the material of the closed end 2108 may be equal to or greater than the thickness 2112 of the wall 2116. In some embodiments, the thickness 2112 of the wall 2116 may be approximately 0.2 mm, approximately 0.25 mm, approximately 0.3 mm, approximately 0.35 mm, approximately 0.4 mm, approximately 0.45 mm, approximately 0.5 mm, approximately 0.55 mm, approximately 0.6 mm, approximately 0.65 mm, approximately 0.7 mm, approximately 0.75 mm, approximately 0.8 mm, approximately 0.85 mm, approximately 0.9 mm, approximately 0.95 mm, approximately 1.0 mm, approximately 1.05 mm, approximately 1.1 mm, approximately 1.15 mm, approximately 1.2 mm, or approximately 1.25 mm, or any value or range within any of these ranges or numerical values, or any range bounded by any of these ranges or numerical values. In some cases, values ​​outside these numerical values ​​or ranges may also be used. Additionally or alternatively, in some embodiments, the thickness 2112 may be approximately 0.60 mm to approximately 0.90 mm. Additionally or alternatively, in some embodiments, the thickness 2112 may be approximately 0.70 mm to approximately 0.80 mm.

[0166] Figure 24 shows the interaction between the dispense cap 1902 and the tube body 1904. The dispense cap 1902 may include a collar 2022, which can form a fluid-tight barrier with respect to the neck region 2102 of the tube body 1904. The interaction between the collar 2022 and the neck region 2102 may conform to embodiments of the present disclosure (for example, the filter tube assembly 1100 described with reference to Figure 17). The collar 2022 may contact the inner circumference of the open end 2106 of the tube body 1904, thereby forming a fluid-tight seal. When the dispense cap 1902 is attached to the open end 2106 of the tube body 1904, the collar 2022 and the wall of the neck region 2102 may press against each other, as indicated by the dashed arrow in the inset of Figure 24. When the dispense cap 1902 is attached to the open end 2106 of the tube body 1904, the proximal surface 2402 of the cap flange 2010 may abut against the distal surface 2404 of the tube flange 2110. In some embodiments, the cap flange 2010 does not need to abut against the tube flange 2110 to ensure that an effective seal is formed between the dispense cap 1902 and the tube body 1904. In such embodiments, there may be sufficient interference fit to form an effective seal between the dispense cap 1902 and the tube body 1904 without contact between the cap flange 2010 and the tube flange 2110. Such interference fit may occur in the assembly portion 2406. The interference fit in the assembly portion 2406 may form a plug seal.

[0167] Figures 25 to 25D illustrate a series of steps for preparing a filter tube assembly 1900 for use in filtering a sample-containing fluid. Figure 25A shows the insertion of the filter 1108 into the dispense cap 1902 and the attachment of the dispense cap 1902 to the tube body 1904 via the tethering 1910 and arm 1906. Figure 25B shows the removal of the seal 1502 from the tube body 1904. Figure 25C shows the closure of the tube body 1904 by the dispense cap 1902. Figure 25D shows the filter tube assembly 1900 ready for compression to filter the sample-containing fluid contained within.

[0168] When preparing the filter tube assembly 1900 for use, the process (method), as shown in Figure 25A, may optionally include inserting the filter 1108 into the dispense cap 1102 and / or attaching the dispense cap 1902 to the tube body 1904 via the arm 1906 and tethering 1910. The step of placing the filter 1108 into the dispense cap 1902 may be performed according to this disclosure. The tethering 1910 may surround the circumference of the tube body 1904 and engage with a plurality of teeth 2120. In some other embodiments, the filter tube assembly 1900 may be supplied to the user with the filter 1108 already positioned within the dispense cap 1902. In some embodiments, the filter tube assembly 1900 may be supplied to the user with the dispense cap 1902 already coupled to the tube body 1904 via the arm 1906 and tethering 1910.

[0169] In embodiments where the filter tube assembly 1900 includes a seal 1502, the seal 1502 can be removed by the user. The user can remove the seal 1502, for example, by grasping the tab portion 1506 and pulling it upward as shown by the dotted arrow in Figure 25B. Once the seal 1502 is removed, the sample can be added to the tube body 1904.

[0170] After the sample is added to the tube body 1904, the tube body 1904 can be closed with the dispense cap 1902. The arm 1906 is bendable and / or foldable, allowing the user to position the dispense cap 1902 on the tube body 1904, as indicated by the dotted arrow in Figure 25C.

[0171] When the dispense cap 1902 is positioned on the tube body 1904, the user can compress the side of the tube body 1904 as indicated by the dotted arrow in Figure 25D. The user can also invert the filter tube assembly 1900 to guide the filtered sample-containing fluid produced by the filter tube assembly 1900 into a container (e.g., a test device) for receiving the filtered sample-containing fluid.

[0172] [E. Method for preparing sample fluids] Figure 26 shows an exemplary method 2600 for preparing a sample for a molecular assay using a filter tube assembly according to the present disclosure.

[0173] In step 2602, the sample is introduced into a buffer solution, thereby generating a sample-containing fluid. In some embodiments, when the sample is introduced into the buffer solution, the buffer solution may be located within the tube body of the filter tube assembly. In some embodiments, the sample may be introduced into the buffer solution at a location other than the tube body of the filter tube assembly. In such embodiments, after the sample has been introduced into the buffer solution, the user may dispense the sample-containing fluid into the tube body of the filter.

[0174] In step 2604, the dispense cap is attached to the tube body. In some embodiments, the step of attaching the dispense cap to the tube body includes engaging the dispense cap with snap-fit ​​features (e.g., ridges and / or recesses) of the tube body. In such embodiments, the snap-fit ​​features (e.g., ridges and / or recesses) may provide the user with tactile or auditory feedback that the dispense cap is secured to the tube body. In such embodiments, the step of engaging the snap-fit ​​features may form a fluid-tight seal between the dispense cap and the tube body. In some embodiments, the step of attaching the dispense cap to the tube body includes engaging the collar of the dispense cap with the open end of the tube body, thereby creating a fluid-tight seal (e.g., a plug seal).

[0175] In step 2606, the tube body is compressed. Compressing the tube body may propel the sample-containing fluid held within the tube body through a filter positioned within the dispense cap. After passing through the filter, the sample-containing fluid may be discharged (sprayed) from the dispense cap. In some embodiments, the user may compress the tube body once, twice, three times, or four times or less to propel a desired volume (amount) of filtered sample-containing fluid from the filter tube assembly. In some embodiments, the filtered sample-containing fluid is propelled from the filter tube assembly to a test device (e.g., a test device on which a molecular assay is performed).

[0176] (Examples) [Example 1. Effectiveness of the filter] Tests were conducted to determine the assay sensitivity of the filtered sample-containing fluid. Filter tube assemblies according to embodiments of Figures 1A to 7 of this disclosure were used, and each filter tube assembly contained one of several different types of filter material as filter 102. Table 1 shows the reactivity of various filters, including: HDC40, HDC5, and HDC20 (LA1244) (meltblown polypropylene filters from Pall Corporation (Port Washington, New York)), Omnipore® filter (hydrophobic PTFE filter from MilliporeSigma (Burlington, Massachusetts)) (hereinafter "Omnipore"), Poly45μM (hydrophobic polypropylene filter from MilliporeSigma), and Vivid ACG (hydrophilic glass fiber filter from Pall Corporation, supplied to BD Veritor® at-home COVID-19 test, FluA+B rapid antigen test, and RSV rapid antigen test (Becton Dickinson, Franklin Lakes, New Jersey)) (hereinafter "Veritor filter"). These filters were used to prepare sample-containing fluids for assays measuring the presence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and internal control (IC). The reactivity of unfiltered samples is also shown. Detection time (Td) is a measurement of amplification time in minutes. A higher Td may be due to inhibition of the assay by the inhibitor. Therefore, a lower Td may indicate that the filter under test removed more inhibitors from the sample-containing fluid compared to the unfiltered sample-containing fluid. Table 1. Reactivity and Td (detection time) TIFF2026512083000002.tif128155

[0177] All of the tested filter materials showed higher reactivity than the unfiltered samples in each of the three assay types. Therefore, the embodiments of the filter tube assemblies according to this disclosure demonstrate improved assay reactivity and sensitivity compared to the unfiltered sample-containing fluid.

[0178] The turbidity of the filtered sample-containing fluid produced by each filter type was measured at a wavelength of 600 nm. Table 2 shows the average OD600 of the filtered sample-containing fluid for each filter type. Here, OD600 refers to the optical density of the sample-containing fluid measured at a wavelength of 600 nm. Of the filter types, the HDC40, HDC5, HDC20, and Veritor filters produced filtered sample-containing fluids with significantly different OD600 values ​​from the unfiltered sample-containing fluid (p=0.05). Table 2. Turbidity at OD600 TIFF2026512083000003.tif51155

[0179] Without being bound by any particular theory, a lower OD600 is considered to indicate that more potential inhibitors are removed by the filtering of the filter tube assembly relating to this disclosure. Turbidity was shown to correlate with assay sensitivity at p=0.05 for both CT and GC assays.

[0180] [Example 2. Effectiveness of sintered polyethylene filter] Tests were conducted to determine the effect of several different types of filter materials on assay sensitivity. Table 3 shows the reactivity of the following sintered polyethylene filters from Porex Corporation (Richmond, Virginia): Porex 120, Porex 266, Porex 269, and Porex 595. Veritor filters, which are hydrophilic glass fiber filters, were also tested. These filters were used in filter tube assemblies according to embodiments of Figures 1A to 7 of this disclosure to perform assays measuring the presence of CT, GC, and internal control (IC). The reactivity of unfiltered samples is also shown. Table 3. Reactivity and Td (detection time) TIFF2026512083000004.tif95155

[0181] Figure 27 plots the optical density (OD600) at a wavelength of 600 nm of sample-containing fluids filtered by each of five filters tested using the filter tube assembly according to the present disclosure, together with the OD600 of the unfiltered sample-containing fluid. Each filter reduced the OD600 compared to the unfiltered sample-containing liquid.

[0182] Figure 28 shows, in a box plot, the human genomic DNA (hugDNA) concentration measured by qPCR in sample-containing fluids filtered by each of the five filters tested using the filter tube assembly according to this disclosure, along with the hugDNA concentration of the unfiltered sample-containing fluid. Figure 28 shows that each filter type tested reduced hugDNA compared to the unfiltered sample-containing fluid.

[0183] [Example 3. Filtration of Urine Sample] Three different urine samples found to be inhibitory to CT assays, GC assays, and / or IC archaeal polymerase amplification (APA) assays were tested with and without filtration. These urine samples were filtered using a filter tube assembly equipped with a Porex120 filter according to the present invention before being used in the assays.

[0184] Figures 29A, 29B, and 29C plot the fluorescence of the CT assay, GC assay, and IC assay, respectively. Solid lines represent fluorescence from filtered samples, and dotted lines represent fluorescence from unfiltered samples. Amplification was improved by filtration in all three assays. Amplification was restored in the IC assay shown in Figure 29C. In particular, the unfiltered sample used in the internal control assay did not amplify, while the increased fluorescence of the filtered sample indicates that the filtered sample was successfully amplified.

[0185] [Example 4. Filtration of the sample for the trichomoniasis assay] Trichomonas protozoa (TV) are parasitic organisms that cause infectious diseases. TV trophozoites are 7–30 μm long, which is 20–100 times longer than those of many other types of bacteria. If TV is present in a vaginal swab sample, it may be detectable. When filtering a sample in preparation for a molecular assay, for example, when filtering using the filter tube assembly according to this disclosure, it may be desirable that the filter does not remove TV trophozoites (therefore compromising or reducing assay sensitivity).

[0186] Samples containing a known amount of TV were filtered according to embodiments of the present disclosure. In particular, the BDMAX® CTGCTV2 assay (Becton Dickinson, Franklin Lakes) was used as a model to measure the relative cycle threshold (Ct) of TV samples before and after filtration using the filter tube assembly according to the present disclosure, with GC as a control. A filter tube assembly with a Porex120 filter according to the present disclosure was used for 1 × 10⁻⁶ filtration. 5 Used to filter 1 mL of BDMAX® buffer with a TV concentration of nutrient / mL. 1 × 10 5 Another 1 mL of BDMAX® buffer with a TV concentration of nutrient / mL was tested in parallel as an "unfiltered" sample. A filter tube assembly with a Porex120 filter according to this disclosure also 10 4 It was used to filter 1 mL of BDMAX® buffer with a GC concentration of cfu / mLGC. 1 × 10 4 Another 1 mL of BDMAX® buffer with a GC concentration of cfu / mLGC was tested in parallel as an "unfiltered" sample.

[0187] TV buffer and GC buffer with and without filtration were used (exposed to, coated) in the amplification assay. Figure 30 plots the mean Ct scores of these samples, with error bars indicating the standard deviation. There was no significant difference in Ct between the TV samples with and without filtration. There was no significant difference between the GC samples with and without filtration. These results suggest that relatively large parasites (e.g., TV) are not removed during filtration of vaginal samples using the filter tube assembly according to this disclosure.

[0188] [term] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art.

[0189] Conjunctions such as "at least one of X, Y, and Z" are generally intended to indicate that an item or term may be one of X, Y, or Z, unless otherwise specified or understood in context. Therefore, such conjunctions are generally not intended to require that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0190] As used herein, degree expressions such as “approximately,” “about,” “generally,” and “substantially” refer to a number, quantity, or characteristic that is close to the stated number, quantity, or characteristic and still performs the desired function or still achieves the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to a quantity that is within the range of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity.

[0191] As used herein, the term "and / or" has its broadest and most unrestrictive meaning, meaning to include A only, B only, both A and B, or A or B alternatively, but not requiring both A and B, nor requiring one of A's, nor requiring one of B's. As used herein, the phrase "at least one of A, B and C" should be interpreted as meaning logical A or B or C using a non-exclusive OR.

[0192] For example, conditional language used herein, such as "can," "could," "might," and "may," is generally intended to convey that a particular feature (function), element, and / or process is optional, unless otherwise stated or understood in context. Therefore, such conditional language is generally not intended to imply that the feature, element, and / or process is required in any way. Terms such as "comprising," "include," and "have" are used in a comprehensive, open-ended manner and do not exclude additional elements, features (functions), actions, operations, etc. The term "or" is used in a comprehensive sense (not exclusive), and when used to connect a list of elements, for example, it means one, some, or all of the elements in the list. Furthermore, the term "each" as used herein, in addition to its usual meaning, can also mean any subset of the set of elements to which the term "each" applies.

[0193] None of the methods disclosed herein need to be performed in the order described. The methods disclosed herein include specific actions performed by the practitioner, but may also include third-party instructions regarding those actions, whether express or implied.

[0194] While the above-mentioned detailed descriptions highlight, explain, and point out novel features, it should be understood that various omissions, substitutions, and modifications may be made to the form and details of the apparatus, systems, and methods without departing from the spirit of this disclosure. For example, features described in various exemplary embodiments may be interchangeable with each other, insofar as they are compatible. As should be recognized, certain parts of the description herein may also be embodied in forms that do not provide all of the features and benefits described herein, since some features may be used or practiced separately from others. Consequently, this disclosure is not intended to be limited to the specific embodiments disclosed herein, but rather to cover all modifications and substitutions that fall within the true scope and spirit of this disclosure.

Claims

1. A filter tube assembly for preparing a sample-containing fluid for use in molecular assays, A dispense cap having a flow path and an opening, A filter positioned within the dispense cap, A tube body having an open end and a closed end, Equipped with, The tube body is configured to hold the sample-containing fluid, The dispense cap is configured to be fixed to the open end of the tube body, At least a portion of the tube body is made of a flexible material, The flexible material is configured such that, when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed, at least a portion of the sample-containing fluid is forced to pass through the filter, the flow path, and the opening. The dispense cap is configured to propel approximately 2.5 mL to approximately 3.0 mL of filtered sample-containing fluid through the opening as a continuous stream during two or fewer compressions of the flexible material. A filter tube assembly characterized by the following features.

2. The filter tube assembly is configured to propel a continuous flow of at least about 1 mL of filtered sample-containing fluid through the opening during a single compression of the tube. The filter tube assembly according to claim 1, characterized in that it is as described above.

3. The flow path has a transition region positioned near the filter, The transition region is configured to reduce the back pressure applied to the filter when the flexible material is compressed. The filter tube assembly according to claim 1 or 2, characterized in that it is as described above.

4. The diameter of the filter is approximately 1.2 to approximately 1.6 times the diameter of the transition region. The filter tube assembly according to claim 3, characterized in that it is as described above.

5. The diameter of the transition region is approximately 8 mm to approximately 12 mm. The filter tube assembly according to claim 4, characterized in that it is as described above.

6. A retaining ring configured to secure the filter to the dispense cap. A filter tube assembly according to any one of claims 1 to 5, further comprising the above.

7. The retaining ring has a groove configured to fit with the ridge on the inner surface of the dispense cap. The filter tube assembly according to claim 6, characterized in that it is as described above.

8. The filter is a cup filter having a wall configured to secure the filter to the dispense cap. A filter tube assembly according to any one of claims 1 to 5.

9. The hardness of the material of the dispense cap is greater than the hardness of the material of the tube body. A filter tube assembly according to any one of claims 1 to 8.

10. The Young's modulus of the material of the dispense cap is at least twice that of the material of the tube body. The filter tube assembly according to claim 9, characterized in that it is as described above.

11. The Young's modulus of the material of the dispense cap is at least about 800 MPa. A filter tube assembly according to any one of claims 1 to 10.

12. The Young's modulus of the material of the tube body is approximately 200 to approximately 300 MPa. The filter tube assembly according to any one of claims 1 to 11.

13. The dispense cap comprises high-density polyethylene (HDPE) or polypropylene. A filter tube assembly according to any one of claims 1 to 12.

14. The material of the tube body includes linear low-density polyethylene (LLDPE). The filter tube assembly according to any one of claims 1 to 13.

15. The dispense cap further comprises a tethering ring configured to engage with the outside of the tube body. A filter tube assembly according to any one of claims 1 to 14.

16. A travel cap configured to be fixed to the open end of the tube body. Furthermore, The travel cap has a collar configured to suppress fluid leakage from the internal volume of the tube body when the travel cap is fixed to the open end of the tube body. The filter tube assembly according to any one of claims 1 to 15.

17. The travel cap has a threaded portion configured to engage with the threaded portion of the tube body. The filter tube assembly according to claim 16, characterized in that it is a filter tube assembly.

18. The dispense cap has a threaded portion configured to engage with the threaded portion of the tube body. The filter tube assembly according to any one of claims 1 to 17.

19. The tube body is at least partially transparent to visible light. The filter tube assembly according to any one of claims 1 to 18.

20. The thickness of at least a portion of the wall of the tube body is approximately 0.2 mm to approximately 1.0 mm. The filter tube assembly according to any one of claims 1 to 19.

21. The filter has a plurality of openings having a diameter of approximately 1 μm to approximately 250 μm. A filter tube assembly according to any one of claims 1 to 20.

22. The filter includes polyethylene, glass fiber, polypropylene, or polytetrafluoroethylene. A filter tube assembly according to any one of claims 1 to 21.

23. The tube body has an internal volume of approximately 3 mL to approximately 5 mL. A filter tube assembly according to any one of claims 1 to 22.

24. The tube body is configured to hold approximately 2.5 mL to approximately 3.5 mL of sample-containing fluid. A filter tube assembly according to any one of claims 1 to 23.

25. The tube body is configured to have a headspace volume of at least 2 mL when the sample-containing fluid is present inside the tube body. A filter tube assembly according to any one of claims 1 to 24.

26. The opening has a diameter, which is approximately 2.8 mm to approximately 3.2 mm. A filter tube assembly according to any one of claims 1 to 25.

27. The filter is configured to filter out molecules that enter from the first surface of the filter and exit from the second surface on the opposite side of the filter. The surface area of ​​the first surface of the filter is approximately 100 mm². 2 ~Approx. 200mm 2 That is A filter tube assembly according to any one of claims 1 to 26.

28. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 That is The filter tube assembly according to claim 27, characterized in that it is as described above.

29. The tube body further comprises a snap-fit ​​ridge and a flange. The snap-fit ​​ridge is configured to engage with the recess of the dispense cap. The flange is configured to contact the proximal end of the dispense cap. A filter tube assembly according to any one of claims 1 to 28.

30. The force required to attach the dispense cap to the tube body is approximately 20 N to 100 N. A filter tube assembly according to any one of claims 1 to 29.

31. The force required to remove the dispense cap from the tube body after it has been snap-fitted is at least about 30 N. A filter tube assembly according to any one of claims 1 to 30.

32. The tube body and the dispense cap are cast as a single piece of plastic. The filter tube assembly further comprises at least one tether connecting the tube body to the dispense cap. The filter tube assembly according to any one of claims 1 to 8 and 16 to 31.

33. The plastic of the tube body and the dispense cap has a Young's modulus of 200 to 700 MPa. The filter tube assembly according to claim 32, characterized in that it is a filter tube assembly as described in claim 32.

34. The seal that covers the open end of the tube body The filter tube assembly according to claim 32 or 33, further comprising the above.

35. The tube body has a filling line that indicates the minimum volume of the molecular assay. A filter tube assembly according to any one of claims 1 to 34.

36. The buffer solution contained within the internal volume of the tube body A filter tube assembly according to any one of claims 1 to 35, further comprising the above.

37. The filter is configured to prepare the sample-containing fluid for use in gonorrhea assays, chlamydia assays, or trichomoniasis assays. A filter tube assembly according to any one of claims 1 to 36.

38. The aforementioned molecular assay is a point-of-care molecular assay. A filter tube assembly according to any one of claims 1 to 37.

39. The aforementioned dispense cap further has a color, The tube body has a neck region configured to engage with the collar of the dispense cap to form a fluid-tight seal. The collar and the neck region are configured to engage with each other via interference fit. A filter tube assembly according to any one of claims 1 to 38.

40. The thickness of the wall at the proximal end of the collar of the dispense cap is smaller than the thickness of the wall at the distal end of the collar of the dispense cap. The filter tube assembly according to claim 39, characterized in that it is as described above.

41. The outer diameter of the wall at the proximal end of the collar of the dispense cap is smaller than the outer diameter of the wall at the distal end of the collar of the dispense cap. The filter tube assembly according to claim 39 or 40, characterized in that it is a filter tube assembly.

42. The collar of the dispense cap has a first ridge. The neck region of the tube body has a second ridge, The first ridge and the second ridge are configured to engage in a sliding manner. The filter tube assembly according to any one of claims 39 to 41.

43. The tube body further has a base portion positioned near the closed end of the tube body, The base portion has a diameter smaller than the diameter of the neck region. The filter tube assembly according to any one of claims 39 to 42.

44. The dispense cap has one or more retaining bumps configured to hold the filter within the dispense cap. A filter tube assembly according to any one of claims 1 to 43.

45. A method for preparing a sample for a molecular assay, The process involves fixing a dispense cap with a filter to the open end of the tube body, A step of compressing the tube body two or fewer times, thereby promoting the discharge of the sample-containing buffer from the internal volume of the tube body as a continuous stream through the filter and out of the dispense cap, while retaining at least some of the inhibitors of the molecular assay from the sample-containing buffer within the filter. The steps include: performing the molecular assay using the filtered sample-containing buffer; A method characterized by comprising:

46. The step of compressing the tube body involves dispensing at least approximately 2.5 mL to approximately 3.0 mL of filtered sample-containing buffer from the dispense cap. The method according to 45, characterized by...

47. The step of fixing the dispense cap to the tube body includes the step of fixing the dispense cap to the tube body via a snap-fit ​​connection. The method according to 45 or 46, characterized by the features described above.

48. The molecular assay includes amplification of nucleic acids in the filtered sample-containing buffer. The method according to any one of 45 to 47, characterized by...

49. Steps to introduce the sample into the buffer in order to form the sample-containing buffer. Furthermore, The buffer solution is held within the internal volume of the tube body. The method according to any one of 45 to 48, characterized by...

50. The molecular assay is an amplification assay. The method according to any one of 45 to 49, characterized by the features described above.

51. Before the step of fixing the dispense cap to the open end of the tube body, the step of removing the travel cap from the open end of the tube body. The method according to any one of 45 to 50, further comprising the above.

52. Steps to remove the seal covering the open end of the tube body. The method according to any one of 45 to 51, further comprising the above.

53. The dispense cap has a flow path and an opening, The aforementioned channel has a transition region, The diameter of the filter is approximately 1.2 to approximately 1.6 times the diameter of the transition region of the flow path. The method according to any one of 45 to 52, characterized by the features described above.

54. The diameter of the aforementioned filter is in the range of approximately 12 mm to approximately 16 mm. The diameter of the transition region is in the range of approximately 8 mm to approximately 12 mm. The method according to any one of 45 to 53, characterized by...

55. The step of compressing the tube body includes filtering molecules from the sample-containing buffer that enters the first surface of the filter and exits from the second surface of the filter, The surface area of ​​the aforementioned filter is approximately 100 mm². 2 ~Approx. 200mm 2 That is The method according to any one of 45 to 54, characterized by...

56. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 That is The method according to any one of 45 to 55, characterized by...

57. A filter tube assembly for preparing a sample-containing fluid for use in molecular assays, A dispense cap having a flow path and an opening, A filter positioned within the dispense cap, A tube body having an open end and a closed end, Equipped with, The aforementioned channel has a transition region, The diameter of the filter is approximately 1.2 to 1.6 times the diameter of the transition region of the flow path. The tube body is configured to hold the sample-containing fluid, The dispense cap is configured to be fixed to the open end of the tube body, At least a portion of the tube body is made of a flexible material, The flexible material is configured such that, when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed, at least a portion of the sample-containing fluid is forced to pass through the filter, the flow path, and the opening. The dispense cap is configured to propel a continuous stream of filtered sample-containing fluid through the opening. A filter tube assembly characterized by the following features.

58. The diameter of the aforementioned filter is in the range of approximately 12 mm to approximately 16 mm. The diameter of the transition region is in the range of approximately 8 mm to approximately 12 mm. The filter tube assembly according to claim 57, characterized in that it is a filter tube assembly.

59. A filter tube assembly for preparing a sample-containing fluid for use in molecular assays, A dispense cap having a flow path and an opening, A filter positioned within the dispense cap, A tube body having an open end and a closed end, Equipped with, The filter is configured to filter molecules from a sample-containing fluid that enters from the first surface of the filter and exits from the second surface of the filter. The surface area of the filter is about 100 mm 2 to about 200 mm 2 and The tube body is configured to hold the sample-containing fluid within its internal volume. The dispense cap is configured to be fixed to the open end of the tube body, At least a portion of the tube body is made of a flexible material, The flexible material is configured such that, when the dispense cap is fixed to the open end of the tube body and the flexible material is compressed, at least a portion of the sample-containing fluid is forced to pass through the filter, the flow path, and the opening. The dispense cap is configured to propel a continuous stream of filtered sample-containing fluid through the opening. A filter tube assembly characterized by the following features.

60. The ratio a:v of the surface area a of the first surface of the filter to the internal volume v of the tube body is approximately 20 m -1 ~about 40m -1 That is The filter tube assembly according to claim 59, characterized in that it is as described above.

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