Filter tube assembly

Abstract

The utility model discloses a filter tube assembly. A filter tube assembly is provided. In one aspect, the filter tube assembly includes a filter, a dispensing cap, and a tube body. The filter tube assembly may be used to filter a buffer fluid containing a sample in preparation for molecular assays. The filter tube assembly may dispense a fluid volume for molecular assays in no more than two compressions of the tube body of the filter tube assembly.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 495,271, filed on April 10, 2023, and U.S. Provisional Application No. 63 / 570,750, filed on March 27, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The systems and methods disclosed herein relate to biological sample collection, processing and testing. More specifically, the systems, devices and methods disclosed herein relate to test kits for preparing samples for molecular assays. Background Art

[0004] Molecular assays can be used for medical diagnosis. For example, molecular assays can be used to test for the presence of markers that are indicative of specific diseases and / or conditions.

[0005] Nucleic acid amplification is an exemplary molecular assay. Amplification of nucleic acids is important in many fields, including medical, biomedical, environmental, veterinary, and food safety testing. Exemplary methods of nucleic acid amplification include polymerase chain reaction (PCR) amplification, isothermal amplification, and / or archaeal polymerase amplification (APA).

[0006] Nucleic acid amplification can produce a large number of replicas of the target gene sequence in the test solution. As a part of the test assay, a specific label can be designed to be linked to the target sequence. Once combined, the label can provide a detectable signal from the test solution, such as an optical signal. The change of the optical signal can include the change of the color, opacity, bioluminescence and / or fluorescence of the test solution. In the case of a fluorescent marker beacon, each marker molecule can be configured with a fluorescence quencher (florescence quencher) that is very close to the fluorescent atom or atomic arrangement. The marker molecule can be configured so that when selectively bound to the target nucleic acid sequence, the quencher and the fluorophore are separated, and then the fluorescent signal can be detected by the effect of the fluorophore. In this arrangement, the fluorescence intensity of the target solution indicates the relative amount of the target gene material in the test solution. Then, the signal can be used to form the basis of a diagnostic test to determine the presence or absence and relative amount of the target material or analyte of interest in the sample to be tested. Utility Model Content

[0007] The devices, systems and methods of the present disclosure each have several innovative aspects, no single one of which is solely responsible for its desirable attributes.Without limiting the scope of the disclosure, its more salient features will now be discussed briefly.

[0008] In one aspect, a filter tube assembly for preparing a sample-containing fluid for use with a molecular assay is provided. The filter tube assembly may include a dispensing cap including a flow path and an orifice; a filter positioned within the dispensing cap; and a tube body including an open end and a closed end. The tube body is configured to accommodate a sample-containing fluid, and the dispensing cap is configured to be fixed to the open end of the tube body. At least a portion of the tube body includes a flexible material configured to be compressed to force one or more continuous flows of the sample-containing fluid through the filter, the flow path, and the orifice when the dispensing cap is fixed to the open end of the tube body and the flexible material is compressed. The dispensing cap may be configured to advance about 2.5 mL to about 3.0 mL of the filtered sample-containing fluid through the orifice during no more than two compressions of the flexible material. The filtered sample-containing fluid may be advanced through the orifice in a continuous flow.

[0009] The filter tube assembly can be configured to propel a continuous flow of at least about 1 mL of filtered sample-containing fluid through the orifice upon a single compression of the tube. The flow path can include a transition zone positioned near the filter, the transition zone being configured to reduce the back pressure on the filter upon compression of the flexible material. The diameter of the filter can be from about 1.2 to about 1.6 times larger than the diameter of the transition zone. The diameter of the transition zone can be between about 8 mm and about 12 mm. The filter tube assembly can include a retaining ring configured to secure the filter to the dispensing cap. The retaining ring can include a groove configured to engage cooperatively with a ridge of the inner surface of the dispensing cap. In some other embodiments, the filter is a cup filter, the cup filter including a wall configured to secure the filter to the dispensing cap. The hardness of the material of the dispensing cap can be greater than the hardness of the material of the tube body. The Young's modulus of the material of the dispensing cap can be at least twice as large as the Young's modulus of the material of the tube body. The Young's modulus of the material of the dispensing cap can be at least about 800 MPa. The Young's modulus of the material of the tube body is from about 200MPa to about 300MPa. The distribution cap may include high-density polyethylene (HDPE) or polypropylene. The tube body material may include low-density polyethylene (LDPE) or linear low-density polyethylene (LLDPE). The distribution cap may include a tether ring configured to engage the outside of the tube body. The filter tube assembly may 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 create a plug seal, thereby inhibiting fluid from leaking 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 the threaded portion of the tube body. The distribution cap may include a threaded portion configured to engage 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 between about 0.20mm and about 1mm. The filter may include a plurality of openings having a diameter between about 1 μm and about 250 μm. The filter may include polyethylene, glass fiber, polypropylene or polytetrafluoroethylene. The tube body may have an internal volume between about 3 mL and about 5 mL. The tube body may be configured to accommodate about 2.5 mL to about 3.5 mL of a fluid containing a sample. The tube body may be configured to include a headspace volume of at least 2 mL when the fluid containing a sample is present in the tube body. The diameter of the orifice may be between about 2.8 mm and about 3.2 mm. The filter may be configured to filter molecules that enter through a first surface of the filter and leave through an opposite second surface of the filter.The surface area of ​​the first surface of the filter may be from about 100 mm. 2 About 200mm 2 The ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body may be about 20 m -1 About 40m -1 The tube body may include a snap-fit ​​ridge and a flange. The snap-fit ​​ridge may be configured to engage with a notch of the dispensing cap. The flange may be configured to contact the proximal end of the dispensing cap. The force required to snap-fit ​​the dispensing cap to the tube body may be from about 20N to 100N. The force required to remove the dispensing cap from the tube body after snap-fitting may be at least about 30N. The tube body and the dispensing cap may be cast as a single piece of plastic. In embodiments where the tube body and the dispensing cap are cast as a single piece of plastic, the filter tube assembly may include at least one tether connecting the tube body to the dispensing cap. In embodiments where the tube body and the dispensing cap are cast as a single piece of plastic, the plastic of the tube body and the dispensing cap may have a Young's modulus ranging between 200MPa and 700MPa. A seal may cover the open end of the tube body. The tube body may include a fill line indicating a minimum volume for the molecular assay. The filter tube assembly may include a buffer. The buffer may be contained within the internal volume of the tube body. The filter may be configured to prepare a fluid containing a sample for a gonorrhea assay, a chlamydia assay or a trichomoniasis assay. The molecular assay may be a point-of-care molecular assay. The distribution cap may include a collar, and the tube body may include a neck region, which may engage the collar of the distribution 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 distribution cap collar may be less than the thickness of the wall at the distal end of the distribution cap collar. The outer diameter of the wall at the proximal end of the distribution cap collar may be less than the outer diameter of the wall at the distal end of the distribution cap collar. The distribution cap collar may include a first ridge, and the neck region of the tube body may include a second ridge, and the first ridge and the second ridge may be slidably engaged. The tube body may include a base portion positioned near the closed end of the tube body, the base region having a diameter smaller than the diameter of the collar. The distribution cap may include one or more retaining bumps, which are configured to retain the filter in the distribution cap.

[0010] In another aspect, a method for preparing a sample for a molecular assay is provided. The method may include securing a dispensing cap to an open end of a tube body, the dispensing cap including a filter. The method may include compressing the tube body no more than twice, thereby propelling a buffer containing a sample from an internal volume of the tube body through the filter and out of the dispensing cap in a continuous flow, while retaining at least some inhibitors of a molecular assay from the buffer containing the sample in the filter. The method may include performing a molecular assay using the filtered buffer containing the sample.

[0011] Compressing the tube body may advance at least about 2.5 mL to about 3.0 mL of the filtered sample-containing buffer from the dispensing cap. Securing the dispensing cap to the tube body may include securing the dispensing 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 include introducing the sample into a buffer to form the sample-containing buffer, the buffer being contained within the internal volume of the tube body. 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 include removing a travel cap from the open end of the tube body before securing the dispensing cap to the open end of the tube body. The method may include removing and / or destroying a seal covering the open end of the tube body. The dispensing cap may include a flow path and an orifice. The flow path may include a transition zone. The diameter of the filter may be about 1.2 to about 1.6 times larger than the diameter of the transition zone of the flow path. The diameter of the filter may be in the range of from about 12 mm to about 16 mm. The diameter of the transition zone can be in the range of from about 8 mm to about 12 mm. Compressing the tube body can include filtering molecules from a buffer containing a sample that enters a first surface of the filter and exits through a second surface of the filter, the surface area of ​​the filter being about 100 mm. 2 and about 200mm 2 The ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body may be between about 20 m -1 About 40m -1 between.

[0012] In yet another aspect, a filter tube assembly for preparing a fluid containing a sample for use with a molecular assay is provided. The filter tube assembly includes a distribution cap, the distribution cap including a flow path and an orifice. The flow path may include a transition zone. The filter tube assembly may also include a filter, the filter is positioned in the distribution cap, and the diameter of the filter is about 1.2 to about 1.6 times larger than the diameter of the transition zone of the flow path. The filter tube assembly includes a tube body, the tube body includes an open end and a closed end, and the tube body is configured to accommodate a fluid containing a sample. The distribution cap may be configured to be fixed to the open end of the tube body, and at least a portion of the tube body may include a flexible material, the flexible material being configured to be compressed to force at least a portion of the fluid containing the sample to pass through the filter, the flow path and the orifice when the distribution cap is fixed to the open end of the tube body and the flexible material is compressed. The distribution cap may be configured to advance a continuous flow of the filtered fluid containing the sample through the orifice. The diameter of the filter may be in the range of from about 12 mm to about 16 mm. The diameter of the transition zone may range from about 8 mm to about 12 mm.

[0013] In yet another aspect, a filter tube assembly for preparing a sample-containing fluid for use with a molecular assay is provided. The filter tube assembly includes a dispensing cap, the dispensing cap including a flow path and an orifice. The filter tube assembly may include a filter positioned within the dispensing cap, the filter configured to filter molecules from a sample-containing fluid that enters through a first surface of the filter and exits through a second surface of the filter. The surface area of ​​the filter may be about 100 mm 2 and about 200mm 2 between. The filter tube assembly may include a tube body, the tube body including an open end and a closed end, the tube body being configured to contain the sample-containing fluid in an internal volume. The dispensing 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 be compressed when the dispensing cap is fixed to the open end of the tube body and the flexible material is compressed to force at least a portion of the sample-containing fluid to pass through the filter, the flow path, and the orifice. The dispensing cap may be configured to advance a continuous flow of filtered sample-containing fluid through the orifice. The ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body may be about 20 m -1 About 40m -1 between.

[0014] The embodiments provided herein include the following numbered embodiments:

[0015] 1. A filter tube assembly for preparing a fluid containing a sample for use with a molecular assay, the assembly comprising:

[0016] a dispensing cap comprising a flow path and an orifice,

[0017] a filter positioned within the dispensing cap; and

[0018] A tube body, the tube body comprising an open end and a closed end, the tube body being configured to contain a sample-containing fluid, the dispensing cap being configured to be secured to the open end of the tube body, at least a portion of the tube body comprising a flexible material, the flexible material being configured to be compressed when the dispensing cap is secured to the open end of the tube body and the flexible material is compressed to force at least a portion of the sample-containing fluid through the filter, the flow path, and the orifice, the dispensing cap being configured to propel about 2.5 mL to about 3.0 mL of filtered sample-containing fluid through the orifice in a continuous flow during no more than two compressions of the flexible material.

[0019] 2. The filter tube assembly of embodiment 1, wherein the filter tube assembly is configured to propel a continuous flow of at least about 1 mL of filtered sample-containing fluid through the orifice upon a single compression of the tube.

[0020] 3. The filter tube assembly of embodiment 1 or 2, wherein the flow path includes a transition zone positioned proximate the filter, the transition zone being configured to reduce back pressure on the filter upon compression of the flexible material.

[0021] 4. The filter tube assembly of embodiment 3, wherein the diameter of the filter is from about 1.2 to about 1.6 times greater than the diameter of the transition zone.

[0022] 5. The filter tube assembly of embodiment 4, wherein the transition zone has a diameter between about 8 mm and about 12 mm.

[0023] 6. The filter tube assembly of any one of embodiments 1 to 5, comprising a retaining ring configured to secure the filter to the dispensing cap.

[0024] 7. The filter tube assembly of embodiment 6, wherein the retaining ring includes a groove configured to matingly engage a ridge of the inner surface of the dispensing cap.

[0025] 8. The filter tube assembly of any one of embodiments 1 to 5, wherein the filter is a cup-style filter comprising a wall configured to secure the filter to the dispensing cap.

[0026] 9. The filter tube assembly of any one of embodiments 1 to 8, wherein the material of the dispensing cap has a harderness that is greater than the hardness of the material of the tube body.

[0027] 10. The filter tube assembly of embodiment 9, wherein the Young's modulus of the material of the dispensing cap is at least twice as great as the Young's modulus of the material of the tube body.

[0028] 11. The filter tube assembly of any one of embodiments 1 to 10, wherein the Young's modulus of the material of the dispensing cap is at least about 800 MPa.

[0029] 12. The filter tube assembly of any one of embodiments 1 to 11, wherein the Young's modulus of the material of the tube body is from about 200 MPa to about 300 MPa.

[0030] 13. The filter tube assembly of any one of embodiments 1 to 12, wherein the dispensing cap comprises high density polyethylene (HDPE) or polypropylene.

[0031] 14. The filter tube assembly of any one of embodiments 1 to 13, wherein the tube body material comprises linear low density polyethylene (LLDPE).

[0032] 15. The filter tube assembly of any one of embodiments 1 to 14, the dispensing cap further comprising a tether ring configured to engage an exterior of the tube body.

[0033] 16. The filter tube assembly according to any one of embodiments 1 to 15 further includes a traveling cap, which is configured to be fixed to the open end of the tube body, and the traveling cap includes an axial ring, which is configured to inhibit fluid from leaking from the internal volume of the tube body when the traveling cap is fixed to the open end of the tube body.

[0034] 17. The filter tube assembly of embodiment 16, wherein the traveling cap includes a threaded portion configured to engage a threaded portion of the tube body.

[0035] 18. The filter tube assembly of any one of embodiments 1 to 17, wherein the dispensing cap includes a threaded portion configured to engage a threaded portion of the tube body.

[0036] 19. The filter tube assembly of any one of embodiments 1 to 18, wherein the tube body is at least partially transparent to visible light.

[0037] 20. The filter tube assembly of any one of embodiments 1 to 19, wherein at least a portion of the wall of the tube body has a thickness between about 0.2 mm and about 1.0 mm.

[0038] 21. The filter tube assembly of any one of embodiments 1 to 20, wherein the filter comprises a plurality of openings having a diameter between about 1 μm and about 250 μm.

[0039] 22. The filter tube assembly of any one of embodiments 1 to 21, wherein the filter comprises polyethylene, fiberglass, polypropylene, or polytetrafluoroethylene.

[0040] 23. The filter tube assembly of any one of embodiments 1 to 22, wherein the tube body has an internal volume between about 3 mL and about 5 mL.

[0041] 24. The filter tube assembly of any one of embodiments 1 to 23, wherein the tube body is configured to hold from about 2.5 mL to about 3.5 mL of fluid containing a sample.

[0042] 25. The filter tube assembly of any one of embodiments 1 to 24, wherein the tube body is configured to include a headspace volume of at least 2 mL when the sample-containing fluid is present in the tube body.

[0043] 26. The filter tube assembly of any one of embodiments 1 to 25, wherein the aperture comprises a diameter, and wherein the diameter is between about 2.8 mm and about 3.2 mm.

[0044] 27. The filter tube assembly of any one of embodiments 1 to 26, wherein the filter is configured to filter molecules that enter through a first surface of the filter and exit through an opposing second surface of the filter, and wherein the surface area of ​​the first surface of the filter is from about 100 mm 2 About 200mm 2 .

[0045] 28. The filter tube assembly of embodiment 27, wherein the ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body is about 20 m -1 About 40m -1 between.

[0046] 29. A filter tube assembly according to any one of embodiments 1 to 28, wherein the tube body further includes a snap-fit ​​ridge and a flange, the snap-fit ​​ridge being configured to cooperatively engage with a recess of the dispensing cap and the flange being configured to contact the proximal end of the dispensing cap.

[0047] 30. The filter tube assembly of any one of embodiments 1 to 29, wherein the force required to attach the dispensing cap to the tube body is from about 20N to 100N.

[0048] 31. The filter tube assembly of any one of embodiments 1 to 30, wherein the force required to remove the dispensing cap from the tube body after snap fit is at least about 30 N.

[0049] 32. The filter tube assembly of any one of embodiments 1-8 or 16-31, wherein the tube body and dispensing cap are cast as a single piece of plastic, and wherein the filter tube assembly includes at least one tether connecting the tube body to the dispensing cap.

[0050] 33. The filter tube assembly of embodiment 32, wherein the plastic of the tube body and dispensing cap has a Young's modulus between 200 MPa and 700 MPa.

[0051] 34. The filter tube assembly of embodiment 32 or 33, comprising a seal covering the open end of the tube body.

[0052] 35. The filter tube assembly of any one of embodiments 1 to 34, wherein the tube body comprises a fill line indicating a minimum volume for use in the molecular assay.

[0053] 36. The filter tube assembly of any one of embodiments 1 to 35, further comprising a buffer contained within the interior volume of the tube body.

[0054] 37. The filter tube assembly of any one of embodiments 1 to 36, wherein the filter is configured to prepare a fluid containing a sample for use in a gonorrhea assay, a chlamydia assay, or a trichomoniasis assay.

[0055] 38. The filter tube assembly of any one of embodiments 1 to 37, wherein the molecular assay is a point-of-care molecular assay.

[0056] 39. A filter tube assembly according to any one of embodiments 1 to 38, wherein the dispensing cap further includes an axial ring, and the tube body includes a neck region, and the neck region is configured to engage the axial ring of the dispensing cap to form a fluid-tight seal, wherein the axial ring and the neck region are configured to engage via an interference fit.

[0057] 40. The filter tube assembly of embodiment 39, wherein the thickness of the wall at the proximal end of the dispensing cap collar is less than the thickness of the wall at the distal end of the dispensing cap collar.

[0058] 41. The filter tube assembly of embodiment 39 or 40, wherein the outer diameter of the wall at the proximal end of the dispensing cap collar is smaller than the outer diameter of the wall at the distal end of the dispensing cap collar.

[0059] 42. The filter tube assembly of any one of embodiments 39 to 41, wherein the dispensing cap collar comprises a first ridge and the neck region of the tube body comprises a second ridge, the first ridge and the second ridge being configured to slidingly engage.

[0060] 43. The filter tube assembly of any one of embodiments 39 to 42, wherein the tube body further comprises a base portion positioned proximate the closed end of the tube body, the base portion comprising a diameter that is smaller than a diameter of the neck region.

[0061] 44. The filter tube assembly of any one of embodiments 1 to 43, wherein the dispensing cap comprises one or more retaining tabs configured to retain the filter within the dispensing cap.

[0062] 45. A method of preparing a sample for a molecular assay, comprising:

[0063] securing a dispensing cap to the open end of the tube body, the dispensing cap including a filter;

[0064] compressing the tube body no more than twice to push the sample-containing buffer from the interior volume of the tube body through the filter and out of the dispensing cap in a continuous flow while retaining at least some inhibitors of the molecular assay from the sample-containing buffer in the filter; and

[0065] Molecular assays are performed using the filtered sample-containing buffer.

[0066] 46. ​​The method of embodiment 45, wherein compressing the tube body pushes at least from about 2.5 mL to about 3.0 mL of filtered sample-containing buffer from the dispensing cap.

[0067] 47. The method of embodiment 45 or 46, wherein securing the dispensing cap to the tube body comprises securing the dispensing cap to the tube body via a snap-fit ​​connection.

[0068] 48. A method according to any one of embodiments 45 to 47, wherein the molecular assay comprises amplification of nucleic acids in a filtered buffer containing the sample.

[0069] 49. The method of any one of embodiments 45 to 48, further comprising introducing the sample into a buffer to form the sample-containing buffer, the buffer being contained within the interior volume of the tube body.

[0070] 50. The method of any one of embodiments 45 to 49, wherein the molecular assay is an amplification assay.

[0071] 51. The method of any one of embodiments 45 to 50, further comprising removing a traveling cap from the open end of the tube body before securing the dispensing cap to the open end of the tube body.

[0072] 52. The method of any one of embodiments 45 to 51, further comprising removing a seal covering the open end of the tube body.

[0073] 53. The method of any one of embodiments 45 to 52, wherein the dispensing cap comprises a flow path and an orifice, the flow path comprises a transition zone, and the diameter of the filter is about 1.2 to about 1.6 times greater than the diameter of the transition zone of the flow path.

[0074] 54. The method of any one of embodiments 45 to 53, wherein the diameter of the filter is in the range of from about 12 mm to about 16 mm, and the diameter of the transition zone is in the range of from about 8 mm to about 12 mm.

[0075] 55. The method of any one of embodiments 45 to 54, wherein compressing the tube body comprises filtering molecules from a buffer containing a sample that enters a first surface of the filter and exits through a second surface of the filter, the surface area of ​​the filter being about 100 mm 2 and about 200mm 2 between.

[0076] 56. The method of any one of embodiments 45 to 55, wherein the ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body is about 20 m -1 About 40m -1 between.

[0077] 57. A filter tube assembly for preparing a fluid containing a sample for use with a molecular assay, the assembly comprising:

[0078] a dispensing cap comprising a flow path and an orifice, the flow path comprising a transition zone,

[0079] a filter positioned within the dispensing cap, the filter having a diameter that is about 1.2 to about 1.6 times greater than a diameter of the transition region of the flow path; and

[0080] A tube body, the tube body comprising an open end and a closed end, the tube body being configured to contain a fluid containing a sample, the dispensing cap being configured to be fixed to the open end of the tube body, at least a portion of the tube body comprising a flexible material, the flexible material being configured to be compressed when the dispensing cap is fixed to the open end of the tube body and the flexible material is compressed to force at least a portion of the fluid containing the sample to pass through the filter, the flow path and the orifice, the dispensing cap being configured to advance a continuous flow of filtered fluid containing the sample through the orifice.

[0081] 58. The filter tube assembly of embodiment 57, wherein the diameter of the filter is in the range of from about 12 mm to about 16 mm, and the diameter of the transition zone is in the range of from about 8 mm to about 12 mm.

[0082] 59. A filter tube assembly for preparing a sample-containing fluid for use with a molecular assay, the assembly comprising:

[0083] a dispensing cap comprising a flow path and an orifice,

[0084] A filter positioned within the dispensing cap, the filter being configured to filter molecules from a fluid containing a sample that enters through a first surface of the filter and exits through a second surface of the filter, the filter having a surface area of ​​about 100 mm 2 and about 200mm 2 between; and

[0085] A tube body, the tube body comprising an open end and a closed end, the tube body being configured to contain the sample-containing fluid in an internal volume, the dispensing cap being configured to be fixed to the open end of the tube body, at least a portion of the tube body comprising a flexible material, the flexible material being configured to be compressed when the dispensing cap is fixed to the open end of the tube body and the flexible material is compressed to force at least a portion of the sample-containing fluid to pass through the filter, the flow path and the orifice, the dispensing cap being configured to advance a continuous flow of filtered sample-containing fluid through the orifice.

[0086] 60. The filter tube assembly of embodiment 59, wherein the ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body is about 20 m -1 About 40m -1 between. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] The above aspects and other features, aspects and advantages of the embodiments of the present disclosure will now be described in conjunction with various embodiments with reference to the accompanying drawings. The illustrated embodiments are merely examples and are not intended to be limiting. Throughout the accompanying drawings, similar symbols generally identify similar components unless the context otherwise indicates.

[0088] Figure 1A-1B Illustrated is a view of an example filter tube assembly that may be used to prepare samples for molecular assays according to embodiments of the present disclosure, wherein the tube body and dispensing cap are separate parts.

[0089] Figure 2A-2F The diagram shows the Figure 1A-1B View of the dispensing cap in the filter tube assembly.

[0090] Figure 3A-3C The diagram shows the Figure 1A-1B View of the filter in the filter tube assembly.

[0091] Figure 4A-4C The diagram shows the Figure 1A-1B View of the retaining ring in the filter tube assembly.

[0092] Figure 5A-5D The diagram shows the Figure 1A-1B A view of the tube body in a filter tube assembly.

[0093] Figure 6 Picture shows Figure 1A-1B Cross-sectional view of a filter tube assembly.

[0094] Figure 7 The diagram shows the Figure 1A-1B Cross-sectional view of the filter and retaining ring within the dispensing cap of the filter tube assembly.

[0095] Figure 8A-8C Illustrated are example steps of attaching a retaining ring to a tube body and closing the open end of the tube body with a dispensing cap according to an embodiment of the present disclosure.

[0096] Figure 9A-9D Illustrated are views of an example traveling cap and tube body according to an embodiment of the present disclosure.

[0097] Figures 10A-10DIllustrated is a view of another example filter tube assembly that may be used to prepare samples for molecular assays according to embodiments of the present disclosure, wherein the tube body and dispensing cap are a single part.

[0098] Figures 11A-11D Illustrated is a view of an example filter tube assembly that may be used to prepare samples for molecular assays according to embodiments of the present disclosure, wherein the tube body and dispensing cap are a single part.

[0099] Figures 12A-12D The diagram shows the Figures 11A-11D View of the dispensing cap in the filter tube assembly.

[0100] Figures 13A-13D The diagram shows the Figures 11A-11D View of the filter in the filter tube assembly.

[0101] Figures 14A-14D The diagram shows the Figures 11A-11D A view of the tube body in a filter tube assembly.

[0102] Figure 15A-15B The diagram shows that Figures 11A-11D A view of a seal used with a filter tube assembly.

[0103] Figure 16A-Figure 17 Picture shows Figures 11A-11D Cross-sectional view of a filter tube assembly showing the interaction of the dispensing cap, tube body and filter.

[0104] Figures 18A-18D Illustration of preparation for use Figures 11A-11D Example steps for filter tube assembly.

[0105] Figures 19A-19D Illustrated is a view of another example filter tube assembly that may be used to prepare samples for molecular assays according to embodiments of the present disclosure, wherein the tube body and dispensing cap are separate parts.

[0106] Figure 20A-Figure 20E The diagram shows the Figures 19A-19D View of the dispensing cap in the filter tube assembly.

[0107] Figure 21A-Figure 21D The diagram shows the Figures 19A-19D A view of the tube body in a filter tube assembly.

[0108] Fig. 22 The diagram shows a seal Figures 19A-19D View of the filter tube assembly.

[0109] Figure 23A-Figure 24 Picture shows Figures 19A-19DCross-sectional view of a filter tube assembly showing the interaction of the dispensing cap, tube body and filter.

[0110] Figure 25A-Figure 25D Illustration of preparation for use Figures 19A-19D Example steps for filter tube assembly.

[0111] Fig.26 is an example flow chart of a method of using a filter tube assembly according to the present disclosure.

[0112] Fig. 27 The optical density of a fluid containing a sample after filtration using a filter tube assembly according to the present disclosure is plotted at a wavelength of 600 nm.

[0113] Fig.28 is a box plot of the concentration of human genomic DNA of a sample containing fluid after filtration using a filter tube assembly according to the present disclosure.

[0114] Figure 29A-29C Fluorescence changes over time for molecular assays for urine samples filtered using a filter tube assembly according to the present disclosure and for unfiltered urine samples are plotted.

[0115] Fig.30 The average cycle threshold values ​​(Ct) for PCR assays for Trichomonas vaginalis and Neisseria gonorrhoeae using unfiltered samples and samples filtered using a filter tube assembly according to the present disclosure are plotted. DETAILED DESCRIPTION

[0116] Embodiments of the present disclosure provide equipment, systems and methods for preparing solutions (e.g., fluid samples) for molecular determination. Such molecular determination can be used to detect, for example, genomic material. Genomic material can be derived from samples, such as bacteria, viruses, yeast and / or parasites. Fluid samples can include test samples in buffer solutions. In some cases, the fluid sample is ready for amplification after being transferred from the internal volume of the device through the filter of the device, and is pushed out of the device with one or more streams (e.g., one or more continuous streams of the filtered fluid sample come out of the device). Filtered fluid samples can prepare samples included in molecular determination, such as by removing molecules that may interfere with molecular determination. For example, a portion of the fluid sample can be transferred from the internal volume of the device to a test container that can perform molecular determination (e.g., amplification determination). Throughout the present disclosure, example systems, test kits and methods will be described with reference to the collection, filtration, testing and detection of nucleic acids, but it should be understood that the present technology can be used to collect, test and detect any particles, molecules or analytes of interest.

[0117] Embodiments of the apparatus, system and method according to the present disclosure can advantageously prepare complex crude matrices for detecting nucleic acids of interest in a point-of-care environment, allowing for the removal of assay inhibitors and purification of samples by filtration. In particular, embodiments of the apparatus, system and method described herein can use non-instrumented methods compatible with CLIA exemptions in a point-of-care environment to purify complex crude samples, such as vaginal matrices and urine, throat and nasal swab matrices. Therefore, the apparatus, system and method of the present disclosure advantageously omit the additional steps required for instruments and the use of such instruments, such as centrifugation and solid phase purification. Advantageously, known nucleic acid amplification inhibitors are removed from the crude matrix, with little or no loss of analytes of interest from the sample. Therefore, embodiments of the present disclosure can detect target analytes, such as bacteria, viruses, yeasts and parasites, with increased sensitivity. In addition, embodiments of the apparatus, system and method according to the present disclosure perform events that would lead to failed test events when there is little or no clogging of the filter element.

[0118] As an illustrative example, a collection kit including a filter tube assembly disclosed herein may include a swab, a filter tube assembly, and a test device. The swab may be composed of a material having a desired abrasiveness, a pickup efficiency, and a shedding efficiency for detecting an analyte of interest (such as nucleic acid). The swab may be provided on a handle. The user may use the swab and the handle to collect a sample, such as a vaginal swab, a throat swab, or a nasal swab. After wiping, the user may place the swab in the tube body of the filter tube assembly. The handle may include a breakpoint so that the user may break the swab in the tube body by making the handle angled relative to the inner surface of the tube body without causing the swab to physically contact the surface that may potentially contaminate the swab. In some examples, the sample may be a fluid sample, such as an oral fluid sample or a urine fluid sample from a patient.

[0119] Liquid (e.g., extraction buffer) can be provided in the tube body of the filter tube assembly. In the example of using a swab, when the swab is placed in the tube body of the filter tube assembly, the swab can absorb the extraction buffer. The user can close the distribution cap of the filter tube assembly on the tube body of the filter tube assembly. The user can compress the tube body so that the swab squeezes out the absorbed extraction buffer and any collected analytes of interest (such as nucleic acids). In some examples of the swab in the tube body that the user does not break, the user can add any collected analytes of interest on the swab to the extraction buffer by mixing the swab in the extraction buffer in the tube body and then removing the swab from the tube body. In some examples, for example, in the case of collecting a fluid sample, the fluid sample can be directly added to the extraction buffer in the tube body. After the sample is added to the extraction buffer and the distribution cap of the filter tube assembly is closed on the tube body, the user can compress the tube body to advance the fluid containing the sample through the filter of the filter tube assembly, through the fluid path of the distribution cap, and reach the test device. The filtered sample-containing fluid produced by the apparatus or system of the present disclosure can be used for molecular assays, such as, but not limited to, gonorrhea assays, chlamydia assays, or trichomoniasis assays. The molecular assays can be point-of-care assays. For example, molecular assays can be performed in a clinician's and / or health care provider's office, etc.

[0120] For illustrative purposes, various embodiments will be described below in conjunction with the accompanying drawings. It should be understood that many other embodiments of the disclosed concepts are possible and that various advantages can be achieved using the disclosed embodiments.

[0121] A. Filter tube assembly with disc filter and separate tube body and dispensing cap

[0122] Figure 1A-1B An example filter tube assembly that may be used to prepare a sample for a molecular assay according to an embodiment of the present disclosure is illustrated. Figure 1A An example filter tube assembly 100 is illustrated in side view. Figure 1B Exploded side view showing Figure 1AExample filter tube assembly 100. Filter tube assembly 100 may include filter 102 (e.g., disc filter), dispensing cap 104, and tube body 106. In some embodiments, filter tube assembly 100 may include retaining ring 108 and tether ring 110. Filter tube assembly 100 may be used to prepare a fluid containing a sample for molecular determination. Tube body 106 may be capable of accommodating a fluid, such as a buffer or a fluid containing a sample. When opened, tube body 106 may be capable of receiving a sample, such as a swab on which a sample has been collected. When dispensing cap 104 is attached to tube body 106 and tube body 106 is compressed, filter tube assembly 100 may push the fluid containing the sample from the internal volume of tube body 106 through filter 102 and discharge from dispensing cap 104.

[0123] In some examples, the filter tube assembly 100 can push the filtered fluid containing the sample out of the distribution cap 104 with one or more streams (e.g., at a significantly higher distribution rate than the dropper). In some embodiments of the filter tube assembly according to the present disclosure, the distribution cap is configured to advance the continuous flow of the filtered fluid containing the sample through the orifice during each compression of the tube body. Advantageously, the embodiment of the filter tube assembly can therefore deliver a large amount of filtered fluid containing the sample out of the orifice quickly, accurately and with minimal user interaction, thereby minimizing the risk that the filtered fluid containing the sample will be exposed to pollutants, degradation or damage from the environment or user source before the filtered fluid containing the sample is delivered to the test equipment for performing molecular determination. In a non-limiting embodiment described below, the filter tube assembly according to the present disclosure is configured to advance the filtered fluid containing the sample through the orifice with a continuous flow during one, two, three or four compressions of the tube body. In one example, during no more than two compressions of the tube body, the filtered fluid containing the sample of a total volume of about 2.5mL to about 3.0ml is pushed through the orifice. Each compression may result in a continuous stream of the plurality of continuous streams of fluid being propelled through the orifice. Alternatively, compression of the tube body may result in a single continuous stream of fluid being propelled through the orifice.

[0124] Once filtered using the filter tube assembly 100, the fluid containing the sample can be suitable for molecular assays. For example, the filter tube assembly 100 can be capable of filtering out certain molecules and / or particles that can interfere with molecular assays. Example inhibitors that can be removed by embodiments of the filter tube assemblies described herein include proteins (blood-based and non-blood-based), carbohydrates (e.g., mucins), immunoglobulins, cells and cell debris, host microbiome, human genomic DNA (hugDNA), and salts. Advantageously, embodiments of the filter tube assemblies according to the present disclosure can remove these and other inhibitors, thereby significantly improving assay sensitivity, reducing the time for DNA and RNA amplification, and in some cases preventing test failures caused by excess inhibitors in the crude matrix.

[0125] Compared with other assay types (e.g., immunoassays), molecular assays may require relatively high volumes of fluid containing samples. Therefore, it may be desirable that the filter tube assembly 100 according to an embodiment of the present disclosure can quickly and / or easily distribute the total volume as provided herein. The filter tube assembly 100 can push the filtered fluid containing the sample out of the distribution cap so that the filtration is relatively fast (e.g., within a few seconds of the compression of the tube body 106 or immediately in response to the compression of the tube body 106). In some examples, the filter tube assembly 100 can release the total volume of the filtered fluid containing the sample in no more than two compressions of the tube body 106. Compression can be provided by the user compressing the tube body 106. In some other examples, the filter tube assembly 100 can release the total volume of the filtered fluid containing the sample in no more than one, two, three or four compressions of the tube body 106.

[0126] In some examples, the filter tube assembly 100 can dispense about 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8. 8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9 or 7.0 mL of total volume of filtered fluid, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the filter tube assembly 100 can dispense a total of about 2 mL to 4 mL of filtered fluid. Additionally or alternatively, in some examples, the filter tube assembly 100 can dispense a total of about 2.5 mL to about 3 mL of filtered fluid.

[0127] In some examples, upon a single compression of the tube body 106, the filter tube assembly 100 can dispense a total of approximately 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 mL of filtered fluid, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the filter tube assembly 100 can dispense a total of approximately 0.5 mL to 2 mL of filtered fluid each time the tube body 106 is compressed. Additionally or alternatively, in some examples, the filter tube assembly 100 can dispense a total of approximately 0.5 mL to 1.5 mL of filtered fluid each time the tube body 106 is compressed.

[0128] 1. Dispensing cap

[0129] Figure 2A-2F Illustrated is a view of a dispensing cap 104 included in a filter tube assembly 100 according to an embodiment of the present disclosure. Figure 2A An oblique view of the dispensing cap 104 is shown. Figure 2B A side view of the dispensing cap 104 is illustrated. Figure 2C An oblique side view of the dispensing cap 104 is illustrated. Figure 2D An oblique bottom view of the dispensing cap 104 is illustrated. Figure 2E A cross-sectional side view of the dispensing cap 104 is illustrated. Figure 2F Picture shows Figure 2E An enlarged view of a cross-sectional view of FIG.

[0130] The dispensing cap 104 may include an orifice 202, a flow path 204, a filter cavity 208, an interior 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 tether loop 110 and an arm 218. In some embodiments, the dispensing cap 104 may include buttresses 222. The dispensing cap 104 may also include one or more ridges 210 and notches 212. The flow path 204 may include a transition zone 206.

[0131] The flow path 204 can be a hollow space within the dispensing cap 104 (e.g., within the nozzle 220 of the dispensing cap 104). The orifice 202 can be a hole at the distal end of the nozzle 220. The flow path 204 can be capable of allowing one or more propelled streams of a sample-containing fluid (e.g., a filtered sample-containing fluid) to flow out of the dispensing cap 104. In some examples, the diameter of the orifice 202 can be about 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 mm, or any value or range within or bounded by any of these ranges or values, but values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the orifice 202 can have a diameter of about 2 mm to 4 mm. Additionally or alternatively, in some examples, the orifice 202 can have a diameter of about 2.8 mm to 3.2 mm. According to an embodiment of the present disclosure, the filter cavity 208 can be a space that can receive and hold / hold the filter 102. When the filter 102 is positioned in the dispensing cap 104, the inner wall of the filter cavity 208 can contact the filter 102. For example, when the filter 102 is fixed in the filter cavity 208 by the retaining ring 108, the filter 102 can contact the distal surface 226 of the filter cavity 208. The transition zone 206 can be positioned near the filter cavity 208.

[0132] The transition zone 206 can provide a volume that can push the fluid containing the sample out of the filter 102. The transition zone 206 has a diameter greater than the rest of the flow path 204. Therefore, because the transition zone 206 does not greatly shrink the diameter of the flow path, the transition zone 206 can thereby reduce the back pressure (i.e., the pressure inside the tube body 106 when the tube body 106 is compressed, for example) applied to the filter 102. By reducing the pressure applied to the filter 102, the transition zone 206 can reduce the risk of fracture, rupture and / or slippage of the filter 102 when the tube body 106 is compressed. In some examples, the diameter of the transition zone 206 can be about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm, or any value or range within or bounded by any of these ranges or values, but values ​​outside these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the transition zone 206 may have a diameter of approximately 8 mm to 12 mm. Additionally or alternatively, in some examples, the transition zone 206 may have a diameter of approximately 10 mm.

[0133] The nozzle 220 can extend away from the cap body 224. The inner surface of the nozzle 220 can define a portion of the flow path 204. In some embodiments, the dispensing cap 104 can be supported by the ribs 222. The ribs 222 can stabilize the nozzle 220 and / or prevent or inhibit the nozzle 220 from breaking.

[0134] The arm 218 may extend from the cap body 224 to the tether loop 110. The arm 218 may be able to bend and / or fold to allow the tether loop 110 to approach the proximal end 216 of the dispensing cap 104. The material of the dispensing cap 104 and / or the size of the arm 218 may affect the ability of the arm 218 to fold and / or bend. The tether loop 110 may be attached to the tube body 106, thereby coupling the dispensing cap 104 to the tube body 106 even when the dispensing cap 104 is not attached to the open end 502 of the tube body 106 (see Figure 5A In one example, the tether ring 110 is coupled to the tube body 106 by surrounding the periphery of the tube body 106 between the teeth 508 (see below). Figure 5A-5C describe).

[0135] The cap body 224 may include an interior space 214. The size and shape of the cap body 224 may be designed to engage the open end 502 of the tube body 106. The inner surface of the cap body 224 may include ridges 210 and notches 212 that may engage features of the tube body 106, as described below with reference to Figure 6As discussed above. The ridge 210 and the notch 212 can extend at least a portion of the perimeter of the inner surface of the cap body 224. The cap body 224 can also include a second ridge 210 located adjacent to the filter cavity 208. The filter cavity 208 can be located between the second ridge 210 and the flow path 204. The size of the filter cavity 208 can be designed so that the inner surface of the cap body 224 contacts the side surface 304 of the filter 102 (see Figure 3A-3C ). The second ridge 210 may engage the groove 406 of the retaining ring 108 (see Figure 4A-4B ), thereby holding the retaining ring 108 in place relative to the dispensing cap 104. The second ridge 210 can extend at least a portion of the perimeter of the inner surface of the cap body 224.

[0136] In some embodiments, the dispensing cap 104 may include plastic. In some embodiments, the plastic may be polypropylene or high-density polyethylene. It may be desirable that the size of the dispensing cap 104 and the material of the dispensing cap 104 be selected so that when the tube body 106 of the filter tube assembly 100 is compressed, the dispensing cap 104 is substantially not deformed or deformed to a minimal extent. In some examples, the Young's modulus of the material of the dispensing cap 104 may be approximately 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, 1000, 1010, 1020, 1030, 1040, 1050, 1060, 1070, 1080, 1090, 1100, 1110, 1120, 1130, 1140, 1150, 1160, 1170, 1180, 1190, 2100, 2111, 2190, 2100, 2112, 2130, 2140, 2150, 2160, 2180, 2191, 2200 170、1180、1190、1200、1210、1220、1230、1240、1250、1260、1270、1280、1290、1300、1310、1320、1330、1340、1350、1360、1370、1380、1390、1400、1410、1420、1430、1440、1450、1460、1470、1480、1490、1500、1510、1520、1530、1540、155 0, 1560, 1570, 1580, 1590, 1600, 1610, 1620, 1630, 1640, 1650, 1660, 1670, 1680, 1690, 1700, 1710, 1720, 1730, 1740, 1750, 1760, 1770, 1780, 1790, 1800, 1810, 1820, 1830, 1840, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1960, 1970, 1980, 1990, 2000, 2010, 2020, 2030, 2040, 2050, 2060, 2070, 2080, 2090, 3000, 3010, 3020, 3030, 3040, 3050, 3060, 3070, 3080, 3090 or 4000 MPa, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 104 may be between about 1600 MPa and 2000 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 104 may be between about 1700 MPa and 1800 MPa.Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 104 can be between about 1200 MPa and 1500 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 104 can be between about 1300 MPa and 1400 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 104 can be between about 900 MPa and 1100 MPa. In some embodiments, the hardness of the material of the dispensing cap 104 can be greater than the hardness of the material of the tube body 106 (e.g., the Young's modulus of the material of the dispensing cap 104 can be greater than the Young's modulus of the material of the tube body 106). In some examples, the Young's modulus of the material of the dispensing cap 104 can be at least about 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, or 5.0 times greater than the Young's modulus of the material of the tube body 106, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 104 can be at least 2 times greater (ie, at least twice as great) than the Young's modulus of the material of the tube body 106 .

[0137] In reference Figure 2A-2F In an alternative embodiment to the discussed embodiment, the dispensing cap 104 may include threads that may interact with a threaded portion of the tube body 106. In such an embodiment, a user may secure the dispensing cap 104 to the tube body 106 by rotating the dispensing cap 104 relative to the tube body 106 to engage the threads. In such an embodiment, the dispensing cap 104 may not be snap-fit ​​to the tube body 106.

[0138] 2. Disc filter

[0139] Figure 3A-3C Illustrated is a view of a filter 102 included in a filter tube assembly 100 according to an embodiment of the present disclosure. Figure 3A A perspective view of the filter 102 is illustrated. Figure 3B A side view of the filter 102 is illustrated. Figure 3CA top view of the filter 102 is illustrated. The filter 102 may be a disc filter having a cylindrical shape. The disc filter may be in 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 shape of 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 located in the dispensing cap 104, the first surface 302 may be oriented toward the interior space 214, and the second surface 306 may be oriented toward the flow path 204 and / or the orifice 202.

[0140] In some examples, the diameter 308 of the filter 102 can be approximately 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the diameter 308 can be approximately 12 mm to 16 mm. Additionally or alternatively, in some examples, the diameter 308 can be approximately 14 mm.

[0141] In some examples, the surface area of ​​the first surface 302 or the second surface 306 may be approximately 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 mm. 2 , or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the area of ​​the first surface 302 or the second surface 306 may be approximately 100 mm 2 Up to 200mm 2 Additionally or alternatively, in some examples, the area of ​​the first surface 302 or the second surface 306 may be approximately 140 mm 2 Up to 160mm 2 .

[0142] In some examples, the thickness 310 of the filter can be approximately 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the thickness 310 can be approximately 0.8 to 1.2 mm. Additionally or alternatively, in some examples, the thickness 310 can be approximately 1 mm. Additionally or alternatively, in some examples, the thickness 310 can be approximately 1.3 to 1.8 mm. Additionally or alternatively, in some examples, thickness 310 may be approximately 1.6 mm.

[0143] In some examples, the filter can include a porous material. As the fluid containing the sample is pushed through the filter 102, the size of the pores can affect which particles are filtered. It may be desirable that the size of the pores is small enough to filter particles that may interfere with molecular assays. It may be desirable that the size of the pores is large enough to allow a sufficient volume and rate of fluid to flow through the filter 102 and / or reduce the risk that the filter 102 will be clogged with particles. The pore size (e.g., average pore diameter) of the porous material can be 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 μm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the pore size can be about 5 μm to 25 μm. Additionally or alternatively, in some examples, the pore size can be about 10 μm to 20 μm. Additionally or alternatively, in some examples, the pore size can be about 50 μm to 120 μm. Additionally or alternatively, in some examples, the pore size can be about 20 μm to 25 μm. Additionally or alternatively, in some examples, the pore size can be about 5 μm to 15 μm. The porous material can include multiple tortuous paths. In some examples, the porous material can be hydrophobic. In some examples, the porous material can include polyethylene (PE), polypropylene (PP), or polytetrafluoroethylene (PTFE). In some examples, the porous material can be hydrophilic. In some examples, the porous material can include glass fiber or melt-blown polypropylene (PP). In some examples, the porous material can be a sintered porous material. In some examples, the porous material can be a sintered PE.

[0144] In a non-limiting embodiment, the filter includes 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 can be stacked. A membrane can be arranged closer to a retaining ring (if a retaining ring is provided) and used as a pre-filter. The membrane used as a pre-filter may include pores for maintaining the size and / or shape of large particles, while one or more downstream membranes may include pores for maintaining the size and / or shape of smaller particles. In a non-limiting example, a first tube assembly includes a filter including a single membrane configured to distribute a first fluid containing a sample of a first analyte of interest to be tested. A second tube assembly includes a filter including two membranes configured to distribute a second fluid containing a sample of a second analyte of interest different from the first analyte of interest to be tested. Relative to the first fluid containing a sample, the second fluid containing a sample may include a coarse matrix, for which a two-stage filtration format is optimal.

[0145] 3. Retaining ring

[0146] Figure 4A-4C Illustrated is a view of a retaining ring 108 included in a filter tube assembly 100 according to an embodiment of the present disclosure. Figure 4A A perspective view of the retaining ring 108 is illustrated. Figure 4B A side view of the retaining ring 108 is illustrated. Figure 4C A top view of the retaining ring 108 is shown.

[0147] 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.

[0148] The outer diameter 404 can be selected so that when the retaining ring 108 is positioned within the dispensing cap 104, the outer surface of the retaining ring 108 contacts the surface of the interior space 214 of the dispensing cap 104. The retaining ring 108 can be positioned within the dispensing cap 104 to secure the filter 102 within the filter cavity 208 of the dispensing cap 104. When the filter 102 and the retaining ring 108 are positioned within the dispensing cap 104, the distal surface 410 of the retaining ring 108 can contact the first surface 302 of the filter 102. The distal surface 410 of the retaining ring 108 can press the filter 102 toward and / or against the distal surface 226 of the filter cavity 208. In some examples, the outer diameter 404 can be approximately 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the outer diameter 404 can be approximately 12 to 16 mm. Additionally or alternatively, in some examples, the inner diameter 402 can be approximately 13 to 15 mm. Additionally or alternatively, in some examples, the inner diameter 402 can be approximately 14 mm.

[0149] The groove 406 can extend along at least a portion of the outer perimeter of the retaining ring 108. The groove can be a notch, depression, etc. in the outer perimeter of the retaining ring 108. The groove 406 can engage the second ridge 210 of the dispensing cap 104. The shape and / or size of the groove 406 can be designed so that when the retaining ring 108 is positioned within the dispensing cap 104, the groove 406 securely engages the second ridge 210. The shape and / or size of the groove 406 is designed so that when engaged with the second ridge 210, the groove 406 and the second ridge 210 create a fluid-tight barrier.

[0150] In some embodiments, the notch 408 can extend along at least a portion of the height of the outer surface of the retaining ring 108. The notch 408 can increase the flexibility of the retaining ring 108. For example, the increased flexibility due to including the notch 408 in the retaining ring 108 can allow the retaining ring 108 to be more easily positioned within the dispensing cap 104, such as at a location where the second ridge 210 engages the groove 406.

[0151] The inner diameter 402 can be selected so that the retaining ring 108 has appropriate strength and / or flexibility. The inner diameter 402 can be selected so that when the tube body 106 is compressed, a sufficient area of ​​the first surface 302 of the filter 102 is exposed to the fluid containing the sample, thereby allowing one or more streams of the filtered fluid containing the sample to be pushed into the flow path 204. The one or more streams can be a continuous stream of the fluid pushed into the flow path 204. In some examples, the inner diameter 402 can be about 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm, or any value or range within or bounded by any of these ranges or values, but values ​​outside these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the inner diameter 402 can be about 8 mm to 12 mm. Additionally or alternatively, in some examples, the inner diameter 402 can be about 9 mm to 11 mm. Additionally or alternatively, in some examples, the inner diameter 402 may be approximately 10 mm to 11 mm. Additionally or alternatively, in some examples, the inner diameter 402 may be approximately 10.5 mm.

[0152] 4. Tube body

[0153] Figure 5A-5C Illustrated is a view of a tube body 106 included in a filter tube assembly 100 according to an embodiment of the present disclosure. Figure 5A A perspective view of the tube body 106 is illustrated. Figure 5B A side view of the tube body 106 is illustrated. Figure 5C A cross-sectional side view of the tube body 106 is illustrated. Figure 5D An oblique top view of the tube body 106 is illustrated. The tube body 106 may include an open end 502, a snap fit ridge 504, a flange 506, teeth 508, a fill line 510, a wall 512, a closed end 514, and an interior volume 516.

[0154] The internal volume 516 can contain a fluid, such as a fluid containing a sample. In some examples, the fluid is a buffer to which the sample is added to form a fluid containing the sample. The dispensing cap 104 can be positioned above the open end 502 of the tube body 106 so that the internal space 214 of the dispensing cap 104 is fluidly connected to the internal volume 516, thereby allowing the filter 102 to contact the fluid containing the sample if the tube body 106 is compressed and / or the filter tube assembly 100 is inverted. In some examples, in the uncompressed state, the interior volume 516 is approximately 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0 5, 14, 14.5, or 15 mL, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, in an uncompressed state, the internal volume 516 is approximately 4 mL to 6 mL. Additionally or alternatively, in some examples, the internal volume 516 is approximately 5 mL.In some examples, the tube body 106 can accommodate approximately 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5 .8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7 5, 14, 14.5, or 15 mL of fluid containing the sample, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the tube body 106 can contain about 2 mL to 4 mL of fluid containing a sample. Additionally or alternatively, in some examples, the tube body 106 can contain about 3 mL of fluid containing a sample.In some examples, the tube body 106 may include approximately 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9. , 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, or 10.0 mL of headspace volume (e.g., the volume within the tube body 106 not occupied by fluid when a buffer or sample-containing fluid is present within the tube body 106), or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the tube body 106 can include a headspace volume of about 1 mL to 3 mL. Additionally or alternatively, in some examples, the tube body 106 can include a headspace volume of approximately 2 mL.

[0155] In some embodiments, the internal volume 516 of the tube body 106 can be reduced in order to advance a fluid containing a sample from the filter tube assembly 100 to a testing device, for example, to perform a molecular assay such as, but not limited to, nucleic acid amplification. The reduction in the internal volume 516 can be achieved in several ways. Figure 5A-5CIn the first embodiment shown, the material of the tube body 106 is flexible enough to allow a user to compress the wall 512 of the tube body 106, thereby advancing one or more streams of the filtered fluid containing the sample to the test device through the orifice 202 of the dispensing cap 104. One or more streams can be a continuous stream of the fluid that is advanced through the orifice 202. Flexibility can be generated by a combination of the thickness of the wall 512 and the modulus (e.g., Young's modulus) of the material included in the tube body 106. For example, the thickness of the material near the open end 502 and at the closed end 514 can be equal to or greater than the thickness of the wall 512. This combination of the thickness of the wall 512 and the material of the tube body 106 can be selected so that the tube body 106 can be compressed by the user. In a second embodiment, the tube body 106 can have a thin section extending axially and / or radially in the wall 512, and the thin section gives the tube body 106 a hinge point, at which the wall 512 can be flexed, while the other parts of the wall 512 are thicker and / or harder. The user can then compress the tube body 106, which flexes at the thin hinge point, thereby reducing the internal volume 516 and pushing the fluid containing the sample through the filter 102 and the flow path 204 and out of the orifice 202 of the dispensing cap 104 without requiring the entire wall 512 to be thin enough to flex. Other methods of pushing a stream or other volume of fluid containing the sample from the tube body 106 through the dispensing cap 104 are possible. 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 droplets of fluid when the filter tube assembly 100 is inverted.

[0156] In some embodiments, the thickness 518 of the material of the tube body 106 near the open end 502 can 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 can be equal to or greater than the thickness 520 of the wall 512. In some examples, the thickness 520 of the wall 512 can be approximately 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, or 1.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the thickness 520 is approximately 0.40 mm to 0.60 mm. Additionally or alternatively, in some examples, thickness 520 is about 0.50 mm to 0.60 mm. In some examples, thickness 518 near open end 502 can be about 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, thickness 518 is about 0.90 mm to 1.1 mm. Additionally or alternatively, in some examples, thickness 518 is about 1.0 mm to 1.1 mm. In some examples, the thickness 522 of the closed end 514 can be about 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the thickness 522 is about 0.70 mm to 1.0 mm. Additionally or alternatively, in some examples, the thickness 522 is about 0.80 mm to 0.90 mm.

[0157] 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 examples, the Young's modulus of the material of tube body 106 may be approximately 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580 940, 950, 960, 970, 980, 990, or 1,000 MPa, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these ranges or values ​​may be used in some cases. Additionally or alternatively, in some examples, the Young's modulus of the material of the tube body 106 can be between approximately 200 MPa and 700 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the tube body 106 can be between about 200 MPa and 300 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the tube body 106 can be between about 90 MPa and 200 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the tube body 106 can be between about 800 MPa and 950 MPa. In some embodiments, the hardness of the material of the tube body 106 can be lower than the hardness of the material of the dispensing cap 104 (e.g., the Young's modulus of the material of the tube body 106 can be lower than the Young's modulus of the material of the dispensing cap 104).

[0158] The material included in tube body 106 can be optically transparent, e.g., transparent to visible light. In some examples, the transparency of the material of tube body 106 can allow a user to observe the volume of sample-containing fluid and / or buffer contained within interior volume 516. Fill line 510 can indicate to a user whether a sufficient amount of sample-containing fluid and / or buffer is present within interior volume 516 of tube body 106. In some embodiments, as shown in FIG. Figure 5A-5CAs shown, the fill line 510 can be a raised feature molded into the wall 512. In some embodiments, the fill line 510 can be a depression molded into the wall 512. In some embodiments, the fill line 510 can be printed on the wall 512, for example, with ink or other marking materials. In some embodiments, the tube body 106 can include more than one fill line 510. In such embodiments, each fill line 510 can indicate a different volume. When the filter tube assembly 100 is oriented so that the dispensing cap 104 points upward and the closed end 514 of the tube body 106 points downward, the user can be able to compare the vertical position of the upper surface of the buffer and / or sample-containing fluid within the internal volume 516 relative to the position of the fill line 510. In some examples, the fill line 510 can indicate whether there is a minimum volume of sample-containing fluid required to perform a molecular assay. In some examples where buffer fluid is stored within internal volume 516 over a period of days, weeks, months, and / or years, fill line 510 can indicate whether the buffer volume has been lost beyond a threshold indicated by fill line 510, such as due to evaporation, leakage, and / or escape from tube body 106.

[0159] The dispensing cap 104 can be positioned on and / or over the open end 502. The snap-fit ​​ridge 504 of the tube body 106 can engage the notch 212 of the dispensing cap 104. In some examples, the notch 212 and the snap-fit ​​ridge 504 can cooperatively engage to create a snap-fit ​​connection (see below). Figure 6 When positioned on and / or above the open end 502, the proximal end 216 of the dispensing cap 104 can abut the flange 506. In some embodiments, the proximal end 216 does not need to abut the flange 506 to ensure that an effective seal is formed between the dispensing cap 104 and the tube body 106. The flange 506 can thereby prevent the dispensing cap 104 from further translation in the direction of the closed end 514 of the tube body 106.

[0160] The teeth 508 may be positioned on the outer surface of the tube body 106. The teeth 508 may be positioned closer to the open end 502 than the closed end 514. In some examples, the teeth 508 are positioned near the flange 506. There may be two, three, four, or more teeth positioned along the perimeter of the outer surface of the wall 512. Figure 5A-5C An embodiment is shown that includes four teeth 508 positioned equidistantly around the perimeter of the outer surface of the wall 512. The teeth 508 can engage the tether loop 110 of the dispensing cap 104 (see Figure 8A-8B , which illustrates the positioning of the retaining ring 108 of the dispensing cap to the teeth 508).

[0161] 5. Assembly including dispensing cap, disc filter and tube body

[0162] Figure 6A cross-sectional view of a filter tube assembly 100 according to an embodiment of the present disclosure is illustrated. When the dispensing cap 104 is attached to the open end 502 of the tube body 106, the notch 212 and ridge 210 of the dispensing cap 104 can engage the snap-fit ​​ridge 504 of the tube body 106. When the dispensing cap 104 is attached to the tube body 106, for example, by a snap-fit ​​connection, the proximal end 216 of the dispensing cap 104 can abut the flange 506 of the tube body 106. In some embodiments, the proximal end 216 does not need to abut the flange 506 to confirm that an effective seal is formed between the dispensing cap 104 and the tube body 106.

[0163] The shapes of the notches 212, ridges 210, and snap-fit ​​ridges 504 can all affect the amount of force required to attach the dispensing cap 104 to the tube body 106 and / or remove the dispensing cap 104 from the tube body 106. For example, the shapes and / or angles of the notch curve 602, ridge curve 604, and chamfer 606 can all be changed to increase and / or decrease the force required to snap the dispensing cap 104 onto the tube body 106 and / or remove the dispensing cap 104 from the tube body 106. For example, Figure 6 As shown, the bevel 606 can be a relatively shallow bevel. When the bevel 606 is relatively shallow, the force required to attach (in this non-limiting example, snap) the dispensing cap 104 to the tube body 106 can be relatively low. Increasing the steepness of the bevel 606 can increase the force to attach the dispensing cap 104 to the tube body 106. In some examples, the force applied to attach the dispensing cap 104 to the tube body 106 can be less than the force applied to remove the dispensing cap 104 from the tube body 106. In some examples, the force applied to attach the dispensing cap 104 to the tube body 106 can be about 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, or 120 N, or any value or range within or bounded by any of these ranges or values, but values ​​outside these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the force applied to attach the dispensing cap 104 to the tube body 106 can be about 40 N to 80 N. Additionally or alternatively, in some examples, the force applied to attach the dispensing cap 104 to the tube body 106 can be about 50 N to 70 N. Additionally or alternatively, in some examples, the force applied to attach the dispensing cap 104 to the tube body 106 can be about 55 N to 65 N. Additionally or alternatively, in some examples, the force applied to attach the dispensing cap 104 to the tube body 106 may be approximately 55N to 60N.

[0164] The shape, slope and / or curvature of the notch surface 602 and the ridge surface 604 can affect the force of removing the dispensing cap 104 from the tube body 106. The shape of the notch surface 602 and the ridge surface 604 can be designed to resist the dispensing cap 104 from the tube body 106. For example, Figure 6 As shown, both the notch surface 602 and the ridge surface 604 can be relatively steep, resulting in a relatively high force being required to remove the dispensing cap 104 from the tube body 106. The shape of the notch surface 602 and / or the ridge surface 604 can be designed so that the dispensing cap 104 and the tube body 106 remain attached even when the pressure within the interior volume 516 of the tube body 106 is well above atmospheric pressure due to, for example, compression of the tube body 106 by a user. In some examples, the force applied to remove the dispensing cap 104 from the tube body 106 can be at least about 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, or 200 N, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the force applied to remove the dispensing cap 104 from the tube body 106 can be at least about 125 N. Additionally or alternatively, in some examples, the force applied to remove the dispensing cap 104 from the tube body 106 can be at least about 150 N. It may be desirable for the force to attach the dispensing cap 104 to the tube body 106 to be less than the force to remove the dispensing cap 104 from the tube body 106 .

[0165] Figure 7 A cross-sectional view of the filter 102 and retaining ring 108 positioned within the dispensing cap 104 is illustrated. The dashed arrow indicates the direction of fluid flow through the dispensing cap 104 when the tube body 106 of the filter tube assembly 100 is compressed (e.g., in a distal direction away from the proximal end 216 of the dispensing cap 104). When the tube body 106 of the filter tube assembly 100 is compressed, the fluid containing the sample can flow from the interior space 214 and / or the interior volume 516 (which are fluidly 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 (which includes the transition zone 206, the middle portion 704, and the distal portion 702), and out of the orifice 202.

[0166] As previously described, the transition zone 206 can reduce the back pressure (i.e., the high pressure in the interior space 214 relative to the flow path 204) acting on the filter 102. The transition zone 206 provides a space whose diameter is not much smaller than the diameter of the filter 102 (e.g., the diameter of the first surface 302 or the second surface 306). In some examples, the diameter of the filter 102 is about 1.05, 1.10, 1.15, 1.20, 1.25, 1.30, 1.35, 1.40, 1.45, 1.50, 1.55, 1.60, 1.65, 1.70, 1.75, 1.80, 1.85, 1.90, 1.95, or 2.00 times larger than the diameter of the transition zone 206, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the diameter of the filter 102 is about 1.2-1.6 times larger than the diameter of the transition zone 206. Additionally or alternatively, in some examples, the diameter of the filter 102 is about 1.3-1.5 times larger than the diameter of the transition zone 206. Additionally or alternatively, in some examples, the diameter of the filter 102 is about 1.35-1.45 times larger than the diameter of the transition zone 206. Additionally or alternatively, in some examples, the diameter of the filter 102 is about 1.4 times larger than the diameter of the transition zone 206.

[0167] The shape and / or size of the distal portion 702 and the middle portion 704 of the flow path 204 can also affect the pressure on the filter 102. It may be desirable that the inner surface of the dispensing cap 104 defining the middle portion 704 (referred to as the curved portion 706) includes a gradual curve so that the diameter of the flow path 204 does not suddenly decrease from the transition zone 206 to the distal portion 702. The gradual change in the diameter of the flow path 204 can ensure that the pressure of the fluid containing the sample does not increase or decrease sharply. The inner wall of the dispensing cap 104 defining the distal portion 702 can be shallowly inclined so that the diameter at the proximal portion of the distal portion 702 (e.g., the portion near the middle portion 704) is greater than the diameter of the orifice 202.

[0168] 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 out of the filter tube assembly 100 when the tube body 106 is compressed. It may be desirable that the maximum flow rate be high enough so that the filter tube assembly 100 can dispense the total volume of filtered sample-containing fluid for a molecular assay as previously described in no more than one, two, three, or four compressions of the tube body 106. In some examples, the ratio a:v of the surface area of ​​the first surface 302 of the filter 102 to the interior volume 516 of the tube body 106 can be about 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 m. -1 , or any value or range within or bounded by any of these ranges or values, although values ​​outside of these ranges or values ​​may be used in some cases. Additionally or alternatively, in some examples, the ratio a:v of the surface area of ​​the first surface 302 of the filter 102 to the interior volume 516 of the tube body 106 is about 20-40 m -1 Additionally or alternatively, in some examples, a ratio a:v of the surface area of ​​the first surface 302 of the filter 102 to the interior volume 516 of the tube body 106 is approximately 25-35 m -1 Additionally or alternatively, in some examples, a ratio a:v of the surface area of ​​the first surface 302 of the filter 102 to the interior volume 516 of the tube body 106 is about 30 m -1 The maximum flow rate may be affected by the inner diameter 402 of the retaining ring 108 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 that is propelled by 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 examples, the ratio a:v of the exposed surface area of ​​the first surface 302 of the filter 102 to the internal volume 516 of the tube body 106 may be approximately 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, or 36 m. -1, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these ranges or values ​​may be used in some cases. Additionally or alternatively, in some examples, the ratio a:v of the exposed surface area of ​​the first surface 302 of the filter 102 to the interior volume 516 of the tube body 106 is about 10-25 m -1 Additionally or alternatively, in some examples, the ratio a:v of the exposed surface area of ​​the first surface 302 of the filter 102 to the interior volume 516 of the tube body 106 is about 15-20 m -1 Additionally or alternatively, in some examples, the ratio a:v of the exposed surface area of ​​the first surface 302 of the filter 102 to the internal volume 516 of the tube body 106 is about 17 m -1 .

[0169] Figure 8A-8C Illustrated are example steps for attaching the retaining ring 108 to the tube body 106 and closing the open end 502 using the dispensing cap 104 according to the present disclosure. Fig. 8A The closed end 514 of the tube body 106 is shown inserted into the opening of the retaining ring 108. The retaining ring 108 may be engaged and / or secured by the teeth 508, such as Figure 8B In some non-limiting examples, the retaining ring 108 is held in place relative to the tube body 106 by teeth 508. The teeth 508 can prevent the retaining ring 108 from moving upward or downward relative to the tube body 106 while still allowing the retaining ring 108 to rotate about the longitudinal axis of the tube body 106. The cap body 224 can be moved, for example, by bending and / or folding the arms 218 to attach to and / or close the open end 502 of the tube body 106, such as by Figure 8B Indicated by the direction arrow in the figure. Figure 8C The filter tube assembly 100 is illustrated when the retaining ring 108 and the cap body 224 are attached to the tube body 106 .

[0170] 6. Travel caps and other components for long-term fluid storage

[0171] Figure 9A-9B An example traveling cap 902 is illustrated attached to a tube body 106 according to the present disclosure. Fig. 9A A perspective view of traveling cap 902 attached to tube body 106 is illustrated. Fig. 9B An exploded view of traveling cap 902 and tube body 106 is illustrated. Fig. 9C A side view of traveling cap 902 attached to tube body 106 is illustrated. Fig.9DA cross-sectional side view of a running cap 902 attached to a tube body 106 is illustrated. In some embodiments, a running cap 902 can be used to cover an open end 502. For example, if the tube body 106 is used to store a buffer before filtering a sample using the filter tube assembly 100, a running cap 902 can be used. The running cap 902 can prevent and / or inhibit leakage, release, evaporation, etc. of the fluid contained in the tube body 106. By closing the open end 502 of the tube body 106 with the running cap 902, the loss of the fluid (e.g., buffer) contained in the tube body 106 can be inhibited and / or prevented. The running cap 902 includes a thumb tab 904. The thumb tab 904 may include a furrow 906. The thumb tab 904 may provide a leverage for removing the running cap 902 from the tube body 106. The furrow 906 of the thumb tab 904 may provide additional gripping, allowing the running cap 902 to be removed more easily from the tube body 106.

[0172] The traveling cap 902 may include a collar 908 that may create a fluid-tight barrier (e.g., a plug seal) against a portion of the open end 502 of the pipe body 106. The collar 908 may extend from the cap top 912. The collar 908 may contact the inner perimeter of the pipe body 106 at the open end 502, thereby creating a fluid-tight seal. When the traveling cap 902 is attached to the pipe body 106, the upper portion of the pipe body 106 (e.g., the open end 502) may be wedged between the collar 908 and the traveling cap wall 910. The traveling cap 902 may include a notch 914 extending along at least a portion of the perimeter of the inner surface of the traveling cap 902, which may engage the snap-fit ​​ridge 504 of the pipe body 106. When the traveling cap 902 is attached to the pipe body 106, the traveling cap 902 may abut the flange 506 of the pipe body 106. In some embodiments, cap top 912 may have substantially the same thickness as at least a portion of traveling cap wall 910 .

[0173] In reference Fig. 9A and 9B In an alternative embodiment to the discussed embodiment, the traveling cap 902 may include threads that may interact with a threaded portion of the tube body 106. In such an embodiment, a user may secure the traveling cap 902 to the tube body 106 by rotating the traveling cap 902 relative to the tube body 106 to engage the threads. In such an embodiment, the traveling cap 902 may not be snap-fit ​​to the tube body 106.

[0174] In some embodiments, particularly those embodiments where the fluid (e.g., buffer fluid) is stored within the tube body 106 for an extended period of time (e.g., days, weeks, months, and / or years) before the filter tube assembly 100 is used to filter a fluid containing a sample, a seal can be secured to the open end 502 to prevent evaporation, contamination, etc. of the buffer within the tube body 106. As an illustrative example, the seal can be a foil heat seal. Alternatively, induction sealing can be used to bond the seal to the open end 502 of the tube body 106.

[0175] B. Filter tube assembly with disc filter and single-component tube body and dispensing cap

[0176] Embodiments of filter tube assemblies according to the present disclosure may include a single-piece assembly. For example, in some embodiments, a filter tube assembly may include a dispensing cap and a tube body that are a single component (eg, molded as a single piece of plastic). Figures 10A-10D An example filter tube assembly 1000 that may be used to prepare samples for molecular assays according to embodiments of the present disclosure is illustrated, wherein a dispensing cap 1002 and a tube body 1004 are a single component. Fig. 10A A perspective view of filter tube assembly 1000 is illustrated. Fig. 10B A side view of filter tube assembly 1000 is illustrated. Fig. 10C A perspective view of the filter tube assembly 1000 is illustrated, with directional arrows showing movement of the dispensing cap 1002 to close the open end 1018 of the tube body 1004 . Fig. 10D A cross-sectional side view of filter tube assembly 1000 is illustrated. According to the present disclosure (e.g., with reference to filter tube assembly 100), filter tube assembly 1000 can advance a volume of filtered sample-containing fluid in no more than one, two, three, or four compressions. It should be understood that filter tube assembly 1000 can include various features described herein according to the present disclosure, including the features described with reference to filter tube assembly 100.

[0177] Filter tube assembly 1000 may include an arm 1006 connecting dispensing cap 1002 and tube body 1004. In some embodiments, filter tube assembly 1000 includes two arms. In some embodiments, filter tube assembly 1000 may include only one arm. Arm 1006 may include a notch 1008 that may allow arm 1006 to bend and / or fold. Dispensing cap 1002 may include collar 1010, cap flange 1012, orifice 1016, flow path 1024, transition zone 1026, and ridge 1028. Dispensing cap 1002 may engage retaining ring 108 and filter 102 so that filter 102 is positioned between internal volume 1022 and flow path 1024 of tube body 1004. Ridge 1028 may extend along at least a portion of the inner perimeter of dispensing cap 1002. Ridge 1028 may engage groove 406 of retaining ring 108, thereby retaining ring 108 and filter 102 are fixed in dispensing cap 1002. The flow path 1024 and / or transition zone 1026 can be sized and shaped in accordance with the present disclosure (e.g., with reference to flow path 204 and transition zone 206). In some embodiments, the dispensing cap 1002 can include a rib 1036 positioned around the nozzle 1034, which can support and / or stabilize the nozzle 1034. In some embodiments, the dispensing cap 1002 can include no such rib.

[0178] Tube body 1004 may include tube flange 1014, fill line 510, open end 1018, closed end 1020, wall 1030, and interior volume 1022. Tube body 1004 and / or interior volume 1022 may be sized and / or shaped according to the present disclosure (e.g., with reference to tube body 106 and / or interior volume 516).

[0179] The material included in tube body 1004 can be at least partially optically transparent, for example, at least partially transparent to visible light. In some examples, the transparency of the material of tube body 1004 can allow a user to observe the volume of sample-containing fluid and / or buffer contained within interior volume 1022. Fill line 510 can indicate to a user whether a sufficient amount of sample-containing fluid and / or buffer is present within interior volume 1022 of tube body 1004. In some embodiments, as shown in FIG. Figures 10A-10DAs shown, the fill line 510 can be a raised feature molded into the wall 1030 of the tube body 1004. In some embodiments, the fill line 510 can be a depression molded into the wall 1030. In some embodiments, the fill line 510 can be printed on the wall 1030, for example, with ink or marking material. In some embodiments, the tube body 1004 can include more than one fill line 510. In such embodiments, each fill line 510 can indicate a different volume. When the filter tube assembly 1000 is oriented so that the dispensing cap 1002 points upward and the closed end 1020 of the tube body 1004 points downward, the user can be able to compare the vertical position of the upper surface of the buffer and / or sample-containing fluid within the internal volume 1022 relative to the position of the fill line 510. In some examples, the fill line 510 can indicate whether there is a minimum volume of sample-containing fluid required to perform a molecular assay. In some examples where the buffer fluid is stored within the internal volume 516 over a period of days, weeks, months, and / or years, the fill line 510 can indicate whether the buffer volume has been lost beyond a threshold indicated by the fill line 510, such as due to evaporation or escape from the tube body 1004. In some embodiments where the fluid (e.g., buffer fluid) is stored within the tube body 1004 for an extended period of time (e.g., days, weeks, months, and / or years) before the filter tube assembly 100 is used to filter a fluid containing a sample, a seal can be secured to the open end 1018 to create a fluid-tight barrier to prevent evaporation, contamination, etc. of the buffer within the tube body 1004. As illustrative examples, the seal can be a foil heat seal or an induction seal. Alternatively, in some embodiments, the filter tube assembly 1000 can include a running cap that can create a fluid-tight barrier with the open end 1018 of the tube body 1004.

[0180] In some embodiments, the internal volume 1022 of the tube body 1004 can be reduced in order to advance a fluid containing a sample from the filter tube assembly 1000 to a testing device, for example, to perform a molecular assay such as, but not limited to, nucleic acid amplification. The reduction in the internal volume 1022 can be achieved in several ways. Figures 10A-10DIn the first embodiment shown, the material of the tube body 1004 is flexible enough to allow a user to compress the wall 1030 of the tube body 1004, thereby advancing one or more streams of the filtered sample-containing fluid to the test device through the orifice 1016 of the dispensing cap 1002. The one or more streams can be a continuous stream of fluid that is pushed through the orifice 1016. Flexibility can be generated by a combination of the thickness of the wall 1030 and the modulus (e.g., Young's modulus) of the material included in the tube body 1004. For example, the thickness 1032 of the wall 1030 can be less than the thickness of a portion of the dispensing cap 1002. This combination of the 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 axially and / or radially extending thin sections in the wall 1030 that give the tube body 1004 a hinge point at which the wall 1030 can flex while other portions of the wall 1030 are thicker and / or stiffer. The user can then compress the tube body 1004, which flexes at the thin hinge point, thereby reducing the internal volume 1022 and pushing the fluid containing the sample through the filter 102 and the flow path 1024 and out of the orifice 1016 of the dispensing cap 1002 without requiring the entire wall 1030 to be thin enough to flex. Other configurations for pushing a stream or other volume of fluid containing the sample from the tube body 1004 through the dispensing cap 104 are possible. In other embodiments, the tube body 1004 may not require compression or squeezing to dispense fluid from a container, and may dispense droplets of fluid when the filter tube assembly 1000 is inverted.

[0181] In some embodiments, the thickness of the material of the closed end 1020 can be equal to or greater than the thickness 1032 of the wall 1030. In some examples, the thickness 1032 of the wall 1030 can be about 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, or 1.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the thickness 1032 is about 0.40 mm to 0.60 mm. Additionally or alternatively, in some examples, the thickness 1032 is about 0.45 mm to 0.55 mm. Additionally or alternatively, in some examples, the thickness 1032 is about 0.51 mm.

[0182] The dispensing cap 1002 may include a collar 1010 that may create a fluid-tight barrier against a portion of the open end 1018 of the tube body 1004. The collar 1010 may contact the inner perimeter of the open end 1018 of the tube body 1004, thereby creating a fluid-tight seal. When the dispensing cap 1002 is attached to the open end 1018 of the tube body 1004, the collar 1010 may cause the wall of the tube body 1004 near the open end to flex in an outward direction. When the dispensing cap 1002 is attached to the open end 1018 of the tube body 1004, the cap flange 1012 of the dispensing cap 1002 may abut against the tube flange 1014 of the tube body 1004. In some embodiments, the cap flange 1012 does not need to abut against the tube flange 1014 to confirm that an effective seal is formed between the dispensing cap 1002 and the tube body 1004.

[0183] C. Filter tube assembly with cup filter and single-component tube body and dispensing cap

[0184] As previously mentioned, embodiments of the filter tube assembly according to the present disclosure may include an assembly having a single component, the single component including a tube body and a dispensing cap. For example, in some embodiments, the filter tube assembly may include a dispensing cap and a tube body that may be molded as a single piece of plastic. Figures 11A-11D An example filter tube assembly that may be used to prepare a sample for a molecular assay according to an embodiment of the present disclosure is illustrated. Fig.11A An example filter tube assembly 1100 is illustrated in an oblique view. Fig. 11B An example filter tube assembly 1100 is illustrated in side view. Fig. 11C The filter tube assembly 1100 is illustrated in an exploded side view. Fig.11D The filter tube assembly 1100 is illustrated in an oblique view with the dispensing cap 1102 not secured to the tube body 1104 .

[0185] Filter tube assembly 1100 may include filter 1108 (e.g., cup filter), dispensing cap 1102 and tube body 1104. In some embodiments, filter tube assembly 1100 may include arm 1106 that tethers tube body 1104 to dispensing cap 1102. Filter tube assembly 1100 may be used to prepare a fluid containing a sample for molecular determination. Tube body 1104 may be able to accommodate a fluid, such as a buffer or a fluid containing a sample. When opened, tube body 1104 may be able to receive a sample, such as a swab on which a sample has been collected. When dispensing cap 1102 is attached to tube body 1104 and tube body 1104 is compressed, filter tube assembly 1100 may push the fluid containing the sample from the internal volume of tube body 1104 through filter 1108 and discharge from dispensing cap 1102.

[0186] In some examples, the filter tube assembly 1100 is capable of pushing the filtered sample-containing fluid out of the dispensing cap 1102 in one or more streams (e.g., at a significantly higher dispensing rate than a dropper). In some embodiments of the filter tube assembly according to the present disclosure, the dispensing cap is configured to push a continuous flow of the filtered sample-containing fluid through the orifice during each compression of the tube body. Advantageously, embodiments of the filter tube assembly can therefore deliver a large amount of filtered sample-containing fluid out of the orifice quickly, accurately, and with minimal user interaction, thereby minimizing the risk that the filtered sample-containing fluid will be exposed to environmental or user-derived contaminants, degradation, or damage before the filtered sample-containing fluid is delivered to a test device for performing molecular determinations. In a non-limiting embodiment described below, the filter tube assembly according to the present disclosure is configured to push about 2.5 mL to about 3.0 mL of the filtered sample-containing fluid through the orifice in a continuous flow during one, two, three, or four compressions of the tube body. In one example, during no more than two compressions of the tube body, a total volume of about 2.5 mL to about 3.0 ml of filtered sample-containing fluid is pushed through the orifice. Each compression can result in a continuous stream of multiple continuous streams of fluid being pushed through the orifice. Alternatively, compression of the tube body can result in a single continuous stream of fluid being pushed through the orifice.

[0187] Once filtered using the filter tube assembly 1100, the fluid containing the sample can be suitable for molecular assays. For example, the filter tube assembly 1100 can be capable of filtering out certain molecules and / or particles that can interfere with molecular assays. Example inhibitors that can be removed by embodiments of the filter tube assemblies described herein include proteins (blood-based and non-blood-based), carbohydrates (e.g., mucins), immunoglobulins, cells and cell debris, host microbiome, human genomic DNA (hugDNA), and salts. Advantageously, embodiments of the filter tube assemblies according to the present disclosure can remove these and other inhibitors, thereby significantly improving assay sensitivity, reducing the time for DNA and RNA amplification, and in some cases preventing test failures caused by excess inhibitors in the crude matrix.

[0188] Compared with other assay types (e.g., immunoassays), molecular assays may require relatively high volumes of fluid containing samples. Therefore, it may be desirable that the filter tube assembly 1100 according to an embodiment of the present disclosure can quickly and / or easily distribute the total volume as provided herein. The filter tube assembly 1100 can push the filtered fluid containing the sample out of the distribution cap so that the filtration is relatively fast (e.g., within a few seconds of the compression of the tube body 1104 or immediately in response to the compression of the tube body 1104). In some examples, the filter tube assembly 1100 can release the total volume of the filtered fluid containing the sample in no more than two compressions of the tube body 1104, and the compression can be provided by the user compressing the tube body 1104. In some other examples, the filter tube assembly 1100 can release the total volume of the filtered fluid containing the sample in no more than one, two, three or four compressions of the tube body 1104.

[0189] In some examples, the filter tube assembly 1100 can dispense about 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.9, 8.0 , 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, or 10.0 mL of total volume of filtered fluid, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some instances. Additionally or alternatively, in some examples, filter tube assembly 1100 can dispense a total of approximately 2 mL to 4 mL of filtered fluid. Additionally or alternatively, in some examples, filter tube assembly 1100 can dispense a total of about 2.5 mL to about 3 mL of filtered fluid.

[0190] In some examples, upon a single compression of the tube body 1104, the filter tube assembly 1100 can dispense a total of approximately 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9 , 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 or 5.0 mL of filtered fluid, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the filter tube assembly 1100 can dispense a total of approximately 0.5 mL to 2 mL of filtered fluid each time the tube body 1104 is compressed. Additionally or alternatively, in some examples, the filter tube assembly 1100 can dispense a total of approximately 0.5 mL to 1.5 mL of filtered fluid each time the tube body 1104 is compressed.

[0191] 1. Dispensing cap

[0192] Figures 12A-12D Illustrated is a view of a dispensing cap 1102 included in a filter tube assembly 1100 according to an embodiment of the present disclosure. Fig. 12A An oblique top view of dispensing cap 1102 is illustrated. Fig. 12B A side view of dispensing cap 1102 is illustrated. Fig. 12C An oblique bottom view of the dispensing cap 1102 is illustrated. Fig.12D A side cross-section of the dispensing cap 1102 is illustrated.

[0193] Dispensing cap 1102 may include orifice 1202, flow path 1204, filter cavity 1216, interior space 1212, proximal end 1208, nozzle 1206, cap flange 1210, cap body 1220, collar 1222, and retaining tab 1238. Flow path 1204 may include transition zone 1214.

[0194] Flow path 1204 can be a hollow space within dispensing cap 1102 (e.g., within nozzle 1206 of dispensing cap 1102). Orifice 1202 can be a hole at the distal end of nozzle 1206. Flow path 1204 can be capable of allowing one or more propelled streams of a fluid containing a sample (e.g., a filtered fluid containing a sample) to flow out of dispensing cap 1102. In some examples, the diameter of orifice 1202 can be about 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 mm, or any value or range within or bounded by any of these ranges or values, but values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the orifice 1202 may have a diameter of about 2 mm to 4 mm. Additionally or alternatively, in some examples, the orifice 1202 may have a diameter of about 2.8 mm to 3.2 mm. According to an embodiment of the present disclosure, the filter cavity 1216 may be a space that can receive and hold the filter 1108. When the filter 1108 is positioned in the dispensing cap 1102, the inner wall of the filter cavity 1216 may contact the filter 1108. When positioned to be used as a part of the filter tube assembly 1100, the filter 1108 may contact the distal surface 1218 of the filter cavity 1216. The transition zone 1214 may be positioned near the filter cavity 1216. The diameter of the filter cavity 1216 may be approximately the same as or less than the outer diameter of the filter 1108.

[0195] The retaining projection 1238 can be positioned near the filter cavity 1216. The retaining projection 1238 can prevent or inhibit the filter 1108 from moving away from the filter cavity 1216. The retaining projection 1238 can be used to fix the filter 1108 located in the filter cavity 1216, for example, by contacting, engaging or partially abutting a portion of the filter 1108. Alternatively, when the filter 1108 is located in the filter cavity 1216 and abuts the distal surface 1218, the retaining projection 1238 can be spaced apart from the filter 1108. In such an example, if the filter 1108 moves away from the distal surface 1218, the retaining projection 1238 can contact the filter 1108. For particularly viscous sample fluids, it may be desirable to include retaining projections 1238. The dispensing cap 1102 may include one, two, three, four, five, six or more retaining projections 1238. In some examples, the dispensing cap 1102 may include three retaining projections 1238. The retaining tabs 1238 can be positioned around the perimeter of the interior space 1212 (e.g., on the inner surface of the dispensing cap 1102). In examples where there are two or more retaining tabs, each retaining tab 1238 can be spaced apart from the other retaining tabs 1238. Alternatively, the dispensing cap 1102 can include a single retaining tab 1238 extending along the perimeter of the interior space 1212. The retaining tabs 1238 extend from the inner surface of the dispensing cap 1102. The distance that the retaining projection 1238 extends from the inner surface of the dispensing cap 1102 can be 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29 or 0.30mm, or any value or range within or defined by any of these ranges or values. Additionally or alternatively, the distance that the retaining projection 1238 extends from the inner surface of the dispensing cap 1102 can be about 0.15mm to 0.25mm. Additionally or alternatively, the distance that the retaining projection 1238 extends from the inner surface of the dispensing cap 1102 can be about 0.20mm to 0.25mm. Additionally or alternatively, the distance that the retaining tab 1238 extends from the inner surface of the dispensing cap 1102 can be about 0.21 mm to 0.23 mm. The retaining tab 1238 also allows the filter 1108 (particularly, the cup filter wall 1302) to flexibly pass over the retaining tab 123 during assembly. It may be desirable that the shape and size of the retaining tab 1238 be designed so that the filter 1108 can pass over the retaining tab 1238 during assembly, but the filter 1108 cannot pass back over the retaining tab 1238 during use of the filter tube assembly 1100.Retention tabs 1238 can be configured to retain filter 1108 when a force is applied to filter 1108 during dispensing in a direction opposite to the direction of fluid flow out through orifice 1202 (e.g., a force applied to filter 1108 between a first compression of filter tube assembly 1100 and a second compression of filter tube assembly 1100). In some cases, after compression of filter tube assembly 1100, fluid and / or air can be drawn in a direction opposite to the flow of fluid through filter tube assembly 1100. Retention tabs 1238 can be configured to prevent or inhibit filter 1108 from being dislodged even when filter 1108 is subjected to such fluid and / or air forces.

[0196] The transition zone 1214 can provide a volume that can push the fluid containing the sample out of the filter 1108. The transition zone 1214 has a diameter greater than the rest of the flow path 1204. Therefore, because the transition zone 1214 does not greatly shrink the diameter of the flow path, the transition zone 1214 can thereby reduce the back pressure (i.e., the pressure inside the tube body 1104 when the tube body 1104 is compressed, for example) applied to the filter 1108. By reducing the pressure applied to the filter 1108, the transition zone 1214 can reduce the risk of fracture, rupture and / or slippage of the filter 1108 when the tube body 1104 is compressed. In some examples, the diameter of the transition zone 1214 can be about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm, or any value or range within or bounded by any of these ranges or values, but values ​​outside these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the transition zone 1214 can have a diameter of approximately 8 mm to 12 mm. Additionally or alternatively, in some examples, the transition zone 1214 can have a diameter of approximately 10 mm.

[0197] The nozzle 1206 can extend away from the cap body 1220. The inner surface of the nozzle 1206 can define a portion of the flow path 1204. The diameter of the flow path 1204 can decrease as the flow path 1204 extends toward the orifice 1202. In some embodiments, the dispensing cap 1102 can include ribs positioned around the nozzle 1206, which can support and / or stabilize the nozzle 1206. In some embodiments, the dispensing cap 1102 may not include such ribs.

[0198] The arm 1106 can extend from the cap flange 1210 to the tube body 1104. The arm 1106 can be able to bend and / or fold to allow the dispensing cap 1102 to approach the open end of the tube body 1104. The material of the dispensing cap 1102 and / or the size of the arm 1106 can affect the ability of the arm 1106 to fold and / or bend. In some embodiments, the arm 1106 can include a notch that allows the arm 1106 to bend and / or fold. As discussed, the dispensing cap 1102, the arm 1106, and the tube body 1104 can be cast as a single component, for example, as a single piece of plastic.

[0199] The cap body 1220 may include an interior space 1212. The cap body 1220 may include a collar 1222. The collar 1222 may be sized and shaped to engage the open end 1406 of the tube body 1104. The outer diameter of the collar 1222 may decrease as the collar 1222 extends from near the cap flange 1210 to the proximal end 1208. Such a reduction in diameter may allow the collar 1222 to transmit increasing forces on the inner surface of the tube body 1104 as the collar 1222 is further inserted into the interior of the tube body 1104 (e.g., as the dispensing cap 1102 is secured to the tube body 1104 before filtering a fluid containing a sample using the filter tube assembly 1100). For example, the diameter 1230 may be equal to or greater than the diameter 1232. In some embodiments, diameter 1230 can be about 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, diameter 1230 can be about 15 mm to 20 mm. Additionally or alternatively, in some examples, diameter 1230 can be about 16 mm to 19 mm. Additionally or alternatively, in some examples, diameter 1230 can be about 17 mm to 18 mm. In some embodiments, diameter 1232 can be about 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, diameter 1232 can be about 14 mm to 19 mm. Additionally or alternatively, in some examples, diameter 1232 can be about 15 mm to 18 mm. Additionally or alternatively, in some examples, diameter 1232 can be about 16 mm to 17 mm. In some embodiments, diameter 1232 can be approximately 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 mm smaller than diameter 1230, or any value or range within or bounded by any of these ranges or values. Additionally or alternatively, diameter 1232 can be approximately 0.5 mm to 1.5 mm smaller than diameter 1230. Additionally or alternatively, diameter 1232 can be approximately 0.8 mm to 1.2 mm smaller than diameter 1230. Additionally or alternatively, diameter 1232 can be approximately 0.9 mm to 1.1 mm smaller than diameter 1230. Additionally or alternatively, diameter 1232 can be approximately 1.0 mm smaller than diameter 1230.

[0200] The collar 1222 may optionally include a ridge 1228. The ridge 1228 may engage features of the tube body 1104 according to the present disclosure. The ridge 1228 may extend at least a portion of the outer perimeter of the collar 1222. Fig. 12B , ridge 1228 is defined by an upper bevel 1240, an apex 1242, and a lower bevel 1244. In some examples, the angle of the lower bevel 1244 on ridge 1228 can be less than the angle of the upper bevel 1240 on ridge 1228. The difference in angles between the upper bevel 1240 and the lower bevel 1244 can allow for a smaller force to be required when attaching the dispensing cap 1102 to the tube body 1104 than the force required to remove the dispensing cap 1102 from the tube body 1104. The height of the apex 1242 can be selected so that it is small enough, such as so as not to break the plug seal between the dispensing cap 1102 and the tube body 1104.

[0201] The thickness of the wall of the collar 1222 can decrease as the collar 1222 extends from the cap flange 1210 to the proximal end 1208 of the dispensing cap 1102. For example, the distal collar thickness 1226 can 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 can be able to deflect near the proximal end 1208, which can allow the collar 1222 to fit within the open end of the tube body 1104. The taper on the collar 1222 can help the user create an interference seal with the tube body 1104 with a gradually increasing force. In some embodiments, the gradually increasing force is configured to provide an ergonomic user experience, such as ensuring effective, reliable, and / or comfortable movement as the user couples the dispensing cap 1102 to the tube body 1104. The proximal collar thickness 1224 can be approximately 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the proximal collar thickness 1224 can be approximately 0.5 mm to 1.0 mm. The distal collar thickness 1226 can be approximately 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the distal collar thickness 1226 can be approximately 2.5 mm to 3.5 mm. Additionally or alternatively, in some examples, the distal collar thickness 1226 can be approximately 3.0 mm to 3.3 mm. Additionally or alternatively, in some examples, the distal collar thickness 1226 can be approximately 3.1 mm to 3.2 mm.

[0202] In some embodiments, the outer diameter of the collar 1222 can decrease as the collar 1222 extends from the cap flange 1210. The distal collar diameter 1236 can be greater than the proximal collar diameter 1234. This reduction in the outer diameter of the collar 1222 can allow the dispensing cap 1102 to be secured to the tube body 1104 via an interference fit. This reduction in the outer diameter of the collar 1222 can allow the dispensing cap 1102 to be attached to the tube body 1104 with less force than if the outer diameter of the collar 1222 had not been reduced. In some embodiments, the distal collar diameter 1236 is 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12. 7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9 5.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19. 0, 19.1, 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 20.0, 20.1, 20.2, 20.3, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9 or 21.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the distal collar diameter 1236 may be approximately 16.5 mm to 18.5 mm. Additionally or alternatively, in some examples, the distal collar diameter 1236 may be approximately 17.0 mm to 18.0 mm.In some embodiments, the proximal collar diameter 1234 is 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9 1.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 1 5.0, 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1 8.1, 18.2, 18.3, 18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8, 19.9 or 20.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the proximal collar diameter 1234 may be approximately 15.5 mm to 17.5 mm. Additionally or alternatively, in some examples, the distal collar diameter 1236 may be approximately 16.0 to 17.0 mm. In some embodiments, the difference between the proximal and distal collar diameters 1234, 1236 is 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. In some embodiments, the difference between the proximal and distal collar diameters 1234, 1236 is 0.5 mm to 1.5 mm. In some embodiments, the difference between the proximal and distal collar diameters 1234, 1236 is 1 mm.

[0203] In some embodiments, the dispensing cap 1102 can include plastic. In some embodiments, the plastic can be polypropylene, high-density polyethylene, or linear low-density polyethylene (LLDPE). It may be desirable that the size of the dispensing cap 1102 and the material of the dispensing cap 1102 be selected so that when the tube body 1104 of the filter tube assembly 1100 is compressed, portions of the dispensing cap 1102 (e.g., the nozzle 1206, the cap flange 1210, and / or the cap body 1220) are substantially undeformed or minimally deformed. It may be desirable that the size of the dispensing cap 1102 and the material of the dispensing cap 1102 be selected so that portions of the dispensing cap 1102 (e.g., the collar 1222) can deform when the tube body 1104 of the filter tube assembly 1100 is compressed. In some examples,The Young's modulus of the material of the dispensing cap 1102 may be about 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790 60、770、780、790、800、810、820、830、840、850、860、870、880、890、900、910、920、930、940、950、960、970、980、990、1000、1010、1020、1030、1040、10 50、1060、1070、1080、1090、1100、1110、1120、1130、1140、1150、1160、1170、1180、1190、1200、1210、1220、1230、1240、1250、1260、1270、1280、1290、 1300、1310、1320、1330、1340、1350、1360、1370、1380、1390、1400、1410、1420、1430、1440、1450、1460、1470、1480、1490、1500、1510、1520、1530、1540、1550、1560、1570、1580、1590、1600、1610、1620、1630、1640、1650、1660、1670、1680、1690、1700、1710、1720、1730、1740、1750、1760、1770、1780 3040, 3050, 3060, 3070, 3080, 3090, 3000, 3010, 3020, 3030, 3040, 3050, 3060, 3070, 3080, 3090 or 4000 MPa, or any value or range within or bounded by any of these ranges or values,However, values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 1102 may be between about 200 MPa and 700 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 1102 may be between about 200 MPa and 300 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the dispensing cap 1102 may be between about 400 MPa and 500 MPa.

[0204] According to the present disclosure, the cap flange 1210 can abut a surface of the tube body 1104. In some embodiments, the cap flange 1210 need not abut the tube flange 1410 to confirm that an effective seal is formed between the dispensing cap 1102 and the tube body 1104. In such embodiments, there can be sufficient interference fit to form an effective seal between the dispensing cap 1102 and the tube body 1104 without abutting the cap flange 1210 and the tube flange 1410.

[0205] 2. Cup filter

[0206] In some embodiments, the filter included in the filter tube assembly 1100 can be a cup filter. Cup filter 1108 is an example of a cup filter. As described above, filter cavity 1216 can be a space that can receive and hold filter 1108, and filter 1108 can be received in the filter cavity 1216 of the dispensing cap 1102. The cup filter can be cast as a single piece, for example, cast as a single piece of material. The cup filter can also have a flat surface, and the wall extends from the flat surface, and the wall defines a recess, so that the overall shape of the cup filter is similar to the overall shape of the cup. Figures 13A-13D A view of filter 1108 is illustrated. Fig.13A An oblique bottom view of filter 1108 is illustrated.

[0207] Fig. 13B An oblique top view of filter 1108 is shown. Fig. 13C A cross-sectional side view of filter 1108 is illustrated. Fig.13DA bottom view of a filter 1108 is illustrated. The filter 1108 may include a cup filter wall 1302 having a filter height 1310 and a wall thickness 1312. The 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 a filter depth 1314. The filter 1108 may also include an inner wall corner 1318, an outer wall corner 1320, a recess corner 1322, and a distal corner 1324. The filter 1108 also includes a recess 1326 having an inner diameter 1316. Each of the inner wall corner 1318, the outer wall corner 1320, the recess corner 1322, and the distal corner 1324 may be sharp, blunt, and / or rounded. It should be understood that the cup filter may be used with any suitable filter tube assembly according to the present disclosure.

[0208] In some examples, the outer diameter 1308 of the filter 1108 can be approximately 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the outer diameter 1308 can be approximately 12 mm to 16 mm. Additionally or alternatively, in some examples, the outer diameter 1308 can be approximately 14 mm.

[0209] In some examples, the surface area of ​​the distal surface 1306 can be approximately 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, or 400 mm. 2 , or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the area of ​​the distal surface 1306 may be approximately 100 mm 2 Up to 200mm 2 Additionally or alternatively, in some examples, the area of ​​distal surface 1306 may be approximately 140 mm 2 Up to 160mm 2 .

[0210] In some examples, the inner diameter 1316 of the filter 1108 can be approximately 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the inner diameter 1316 can be approximately 8 mm to 12 mm. Additionally or alternatively, in some examples, the inner diameter 1316 can be approximately 10 mm.

[0211] In some examples, the surface area of ​​the proximal surface 1304 can be approximately 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 mm. 2 , or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the area of ​​the proximal surface 1304 may be approximately 50 mm 2 Up to 100mm 2 Additionally or alternatively, in some examples, the area of ​​the proximal surface 1304 may be approximately 70 mm 2 Up to 90mm 2 .

[0212] In some examples, the filter depth 1314 of the filter 1108 can be approximately 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the filter depth 1314 can be approximately 0.8 mm to 1.2 mm. Additionally or alternatively, in some examples, the filter depth 1314 can be approximately 1 mm. Additionally or alternatively, in some examples, the filter depth 1314 can be approximately 1.3 mm to 1.8 mm. Additionally or alternatively, in some examples, the filter depth 1314 can be approximately 1.6 mm.

[0213] The cup filter wall 1302 can engage the inner perimeter of the dispensing cap 1102. Additionally or alternatively, the cup filter wall 1302 can engage the ridges of the inner perimeter of the dispensing cap 1102. The cup filter wall 1302 can be large enough (i.e., the filter height 1310 can be long enough) so that the surface area of ​​contact (and therefore friction) between the cup filter wall 1302 and the surface of the dispensing cap 1102 within the interior space 1212 is sufficient to prevent and / or inhibit movement of the filter 1108 when the tube body 1104 is compressed. In one example, the filter 1108 is held in place in the dispensing cap 1102 based solely on an interference fit. Advantageously, the ability to hold the filter 1108 in place in the dispensing cap 1102 without adhesives or other chemical bonds can reduce or eliminate the introduction of contaminant elements during filtration and dispensing of the sample. The cup filter wall 1302 can provide structural support to the portion of the filter 1108 between the proximal surface 1304 and the distal surface 1306 so that the portion of the filter 1108 between the proximal surface 1304 and the distal surface 1306 is not collapsed. In some examples, the filter height 1310 of the filter 1108 can be approximately 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, or 4.5 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​may be used in some cases. Additionally or alternatively, in some examples, the filter height 1310 can be approximately 3.6 mm to 4.0 mm. Additionally or alternatively, in some examples, filter height 1310 can be about 3.8 mm to 3.9 mm. Filter height 1310 can be several times greater than filter depth 1314. In some examples, filter height 1310 is 1.5x, 2x, 2.5x, 3x, 3.5x, 4x, 4.5x, 5x, 5.5x, 6x, 6.5x, 7x, 7.5x, 8x, 8.5x, 9x, 9.5x, or 10x, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​may be used in some cases. Additionally or alternatively, in some examples, filter height 1310 is about 1.5 to 3.5 times greater than filter depth 1314. Additionally or alternatively, in some examples, filter height 1310 is about 2.0 to 3.0 times greater than filter depth 1314. Additionally or alternatively, in some examples, filter height 1310 is approximately 2.3 to 2.6 times greater than filter depth 1314 .

[0214] In some examples, the wall thickness 1312 of the filter 1108 can be approximately 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​can be used in some cases. Additionally or alternatively, in some examples, the wall thickness 1312 can be approximately 1.6 mm to 2.4 mm. Additionally or alternatively, in some examples, the wall thickness 1312 can be approximately 1.8 mm to 2.2 mm. Additionally or alternatively, in some examples, the wall thickness 1312 can be approximately 1.9 mm to 2.1 mm.

[0215] The filter 1108 comprises a porous material. The porous material may include pores or spaces whose size and shape are designed to allow fluid to flow from the proximal surface 1304 to the distal surface 1306, but some particles will not pass through. As the fluid containing the sample is pushed through the filter 1108, the size of the pores can affect which particles are filtered. It may be desirable that the size of the pores is small enough to filter particles that may interfere with molecular determinations. It may be desirable that the size of the pores is large enough to allow sufficient volume and rate of fluid to flow through the filter 1108 and / or reduce the risk of the filter 1108 being blocked by particles. The pore size (e.g., average pore diameter) of the porous material can be 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 μm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the pore size can be about 5 μm to 25 μm. Additionally or alternatively, in some examples, the pore size can be about 10 μm to 20 μm. Additionally or alternatively, in some examples, the pore size can be about 50 μm to 120 μm. Additionally or alternatively, in some examples, the pore size can be about 20 μm to 25 μm. Additionally or alternatively, in some examples, the pore size can be about 5 μm to 15 μm. The porous material can include multiple tortuous paths. In some examples, the porous material can be hydrophobic. In some examples, the porous material can include polyethylene (PE), polypropylene (PP), or polytetrafluoroethylene (PTFE). In some examples, the porous material can be hydrophilic. In some examples, the porous material can include glass fiber or melt-blown polypropylene (PP). In some examples, the porous material can be a sintered porous material. In some examples, the porous material can be a sintered PE.

[0216] In a non-limiting embodiment, the filter 1108 includes 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 can be stacked. A membrane can be arranged closer to the proximal surface 1304 and used as a pre-filter. The membrane used as a pre-filter can include pores for maintaining the size and / or shape of large particles, while one or more downstream membranes can include pores for maintaining the size and / or shape of smaller particles. In a non-limiting example, the first tube assembly includes a filter including a single membrane configured to distribute a first sample-containing fluid to be tested for a first analyte of interest. The second tube assembly includes a filter including two membranes configured to distribute a second sample-containing fluid to be tested for a second analyte of interest different from the first analyte of interest. The second sample-containing fluid can include a coarse matrix, for which a two-stage filtration format is optimal relative to the first sample-containing fluid.

[0217] 3. Tube body

[0218] Figures 14A-14D Illustrated is a view of a tube body 1104 included in a filter tube assembly 1100 according to an embodiment of the present disclosure. A dispensing cap 1102 and an arm 1106 are also illustrated. Fig.14A A side view of tube body 1104 is illustrated. Fig. 14B A cross-sectional side view of tube body 1104 is illustrated. Fig. 14C An oblique view of the tube body 1104 is illustrated. Fig.14D A top view of a tube body 1104 is shown. 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 interior volume 1414. The tube body 1104 may optionally include a base region 1404 and a neck region 1402 including a ridge 1418.

[0219] The internal volume 1414 can contain a fluid, such as a fluid containing a sample. In some examples, the fluid is a buffer to which the sample is added to form a fluid containing the sample. The dispensing cap 1102 can be positioned above the open end 1406 of the tube body 1104 so that the internal space 1212 of the dispensing cap 1102 is fluidically connected to the internal volume 1414, thereby allowing the filter 1108 to contact the fluid containing the sample if the tube body 1104 is compressed and / or the filter tube assembly 1100 is inverted. In some examples, in the uncompressed state, the interior volume 1414 is approximately 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.9, 9.0 5, 14, 14.5, or 15 mL, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, in an uncompressed state, the internal volume 1414 is approximately 4 mL to 6 mL. Additionally or alternatively, in some examples, the internal volume 1414 is approximately 5 mL. Additionally or alternatively, in some examples, the internal volume 1414 is approximately 6.7 mL.In some examples, the tube body 1104 can accommodate approximately 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 5, 14, 14.5, or 15 mL of fluid containing sample, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. In one non-limiting embodiment, the tube body 1104 holds about 6.7 mL of fluid containing a sample. Additionally or alternatively, in some examples, the tube body 1104 can hold about 2 mL to 4 mL of fluid containing a sample. Additionally or alternatively, in some examples, the tube body 1104 can hold about 3 mL of fluid containing a sample.In some examples, the tube body 1104 may include approximately 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9. , 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, or 10.0 mL of headspace volume (e.g., the volume within the tube body 1104 not occupied by fluid when a buffer or sample-containing fluid is present within the tube body 1104), or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the tube body 1104 can include a headspace volume of about 1 mL to 3 mL. Additionally or alternatively, in some examples, tube body 1104 can include a headspace volume of approximately 2 mL.

[0220] In some embodiments, the internal volume 1414 of the tube body 1104 can be reduced in order to advance a fluid containing a sample from the filter tube assembly 1100 to a testing device, for example, to perform a molecular assay such as, but not limited to, nucleic acid amplification. The reduction in the internal volume 1414 can be achieved in several ways. Figures 14A-14DIn the illustrated embodiment, the material of the tube body 1104 is flexible enough, particularly the base region 1404, to allow the user to compress the wall 1416 of the tube body 1104, thereby advancing one or more streams of the filtered fluid containing the sample to the test device through the orifice 1202 of the dispensing cap 1102. One or more streams can be a continuous stream of the fluid that is advanced through the orifice 1202. Flexibility can be produced by a combination of the thickness of the wall 1416 and the modulus (e.g., Young's modulus) of the material included in the tube body 1104. This combination of the thickness of the wall 1416 and the material of the tube body 1104 can be selected so that the tube body 1104 can be compressed by the user. In a second embodiment, the tube body 1104 can have a thin section extending axially and / or radially in the wall 1416, and the thin section gives the tube body 1104 a hinge point, at which the wall 1416 can be flexed, while the other parts of the wall 1416 are thicker and / or harder. The user can then compress the tube body 1104, which flexes at the thin hinge point, thereby reducing the internal volume 1414 and pushing the fluid containing the sample through the filter 1108 and the flow path 1204 and out of the orifice 1202 of the dispensing cap 1102 without requiring the entire wall 1416 to be thin enough to flex. Other methods of pushing a stream or other volume of fluid containing the sample from the tube body 1104 through the dispensing cap 1102 are also possible. 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 droplets of fluid when the filter tube assembly 1100 is inverted.

[0221] In some embodiments, the thickness of the material of the tube body 1104 at the tube flange 1410 can be greater than or equal to the thickness of the thickness 1412 of the wall 1416. In some embodiments, the thickness 1412 of the material of the closed end 1408 can be equal to or greater than the thickness 1412 of the wall 1416. In some examples, the thickness 1412 of the wall 1416 can be about 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.05, 1.1, 1.15, 1.2, or 1.25 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the thickness 1412 is about 0.2 mm to 1.0 mm. Additionally or alternatively, in some examples, thickness 1412 is about 0.50 mm to 1.0 mm. Additionally or alternatively, in some examples, thickness 1412 is about 0.60 mm to 0.90 mm. Additionally or alternatively, in some examples, thickness 1412 is about 0.70 mm to 0.80 mm. Additionally or alternatively, in some examples, thickness 1412 is about 0.75 mm.

[0222] The neck region 1402 and the base region 1404 allow the thickness of the tube body 1104 to vary. As an illustrative example, the size and shape of the base region 1404 can be designed so that the height of any liquid contained in the tube body 1104 reaches a suitable height so that the swab head can be immersed in the liquid. As an illustrative example, the base region 1404 can have an inner diameter of 12mm-13mm and a height of 28mm-29mm, while the neck region 1402 can have an inner diameter of 16mm-17mm and a height of 7mm-8mm. In such an example, the tube body 1104 can accommodate 2mL of buffer and can allow an industry standard sample collection swab to be fully immersed when received by the tube body 1104. As another illustrative example, the size and shape of the base region 1404 can be designed so that the tube body 1104 can be placed and maintained in a standard tube rack. The size and shape of the neck region 1402 can be designed to allow the dispensing cap 1102 to be large enough to allow for a suitable filtering surface area (eg, the filtering surface area of ​​the filter 1108).

[0223] The ridge 1418 may be located within the neck region 1402, such as Fig. 14B and Fig. 14C Reference Fig. 14B, ridge 1418 is defined by an upper bevel 1420, an apex 1422, and a lower bevel 1424. In some examples, the angle of the upper bevel 1420 on ridge 1418 can be less than the angle of the lower bevel 1424 on ridge 1418. The difference in angles between the upper bevel 1420 and the lower bevel 1424 can allow for a smaller force to be required when attaching the dispensing cap 1102 to the tube body 1104 than the force required to remove the dispensing cap 1102 from the tube body 1104. The height of the apex 1422 can be selected so that it is small enough, such as so as not to break the plug seal between the dispensing cap 1102 and the tube body 1104.

[0224] 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). The tube body 1104 including LLDPE may advantageously not experience rupture after multiple extrusions. The tube body 1104 including LLDPE may advantageously allow for the relatively low extrusion force required for the compression filter tube assembly 1100 while allowing the wall thickness 1412 to be thick enough to manufacture. Even when a similar or lower force from a user is required to fix the dispensing cap 1102 to the tube body 1104, the tube body 1104 including LLDPE may advantageously apply a higher interference fit force on the dispensing cap 1102. Further, a greater interference fit force may be advantageous because a greater interference fit force may allow for a more robust seal to be formed. Embodiments of the tube body including LLDPE and having a greater interference fit force according to the present disclosure may advantageously provide a more robust tube assembly that is less sensitive to non-circularity, molding tolerances, or damage in the sealing area. In some examples, the Young's modulus of the material of tube body 1104 may be approximately 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580 100, 100, 100, 200, 300, 400, 500, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, or 1,000 MPa, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the Young's modulus of the material of tube body 1104 can be between about 200 MPa and 700 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the tube body 1104 can be between about 200 MPa and 300 MPa. Additionally or alternatively, in some examples, the Young's modulus of the material of the tube body 1104 can be between about 400 MPa and 500 MPa.

[0225] The material included in the tube body 1104 can be optically transparent, for example, transparent to visible light. In some examples, the transparency of the material of the tube body 1104 can allow a user to observe the volume of the fluid containing the sample and / or the buffer contained within the internal volume 1414. In some embodiments, a fill line can be included that can indicate to the user whether there is a sufficient amount of fluid containing the sample and / or the buffer within the internal volume 1414 of the tube body 1104. In some embodiments, the fill line can be a raised feature molded into the wall 1416. In some embodiments, the fill line can be a depression molded into the wall 1416. In some embodiments, the fill line can be printed on the wall 1416, for example, with ink or other marking materials. In some embodiments, the tube body 1104 can include more than one fill line. In such an embodiment, each fill line can indicate a different volume. When the filter tube assembly 1100 is oriented so that the open end 1406 points upward and the closed end 1408 of the tube body 1104 points downward, the user can be able to compare the vertical position of the upper surface of the buffer and / or sample-containing fluid within the internal volume 1414 relative to the position of the fill line. In some examples, the fill line can indicate whether there is a minimum volume of sample-containing fluid required to perform a molecular assay. In some examples where the buffer fluid is stored within the internal volume 1414 over a period of days, weeks, months, and / or years, the fill line can indicate whether the buffer volume has been lost beyond a threshold indicated by the fill line, such as due to evaporation, leakage, and / or escape from the tube body 1104.

[0226] The dispensing cap 1102 can be positioned on and / or above the open end 1406. The collar 1222 of the dispensing cap 1102 can engage the interior of the tube body 1104, such as the interior of the neck region 1402. When the dispensing cap 1102 is secured to the open end 1406 of the tube body 1104, the ridge 1228 of the collar 1222 can be configured to engage the ridge 1418 of the neck region 1402. The engagement of the ridge 1228 with the ridge 1418 can inhibit and / or prevent the dispensing cap 1102 from being removed from the open end 1406 of the tube body 1104. The seal between the collar 1222 and the neck region 1402 can ensure that no or substantially no sample fluid leaks from the filter tube assembly 1100. The seal between the collar 1222 and the neck region 1402 can ensure that maximum fluid is directed toward the filter 1108 when the filter tube assembly 1100 is inverted and / or compressed. Securing the dispensing cap 1102 in the neck region 1402 of the tube body 1104 initially involves applying sufficient force to the top of the dispensing cap 1102 to force the collar 1222 into the open end 1406 of the tube body 1104. As continued pressure is applied to the dispensing cap 1102, the ridge 1228 slides over the ridge 1418. The ridge 1228 and the ridge 1418 can slide over each other so that the user has the ridges 1228 and 1418 already engaged and forming a seal between the dispensing cap 1102 and the open end 1406 of the tube body 1104 (e.g., see FIG. 1 ). Fig.17 1710). Tactile feedback can be particularly useful because the sound of ridges 1228 and 1418 sliding past each other can be dampened by the sound generated inside the tube assembly 1100. The shape and size of the neck portion 1402 can be designed 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. Reducing the non-circularity of the neck portion 1402 can advantageously help maintain the plug seal in the assembly portion 1710 during fluid dispensing.

[0227] When the dispensing cap 1102 is positioned on and / or over the open end 1406, the cap flange 1210 of the dispensing cap 1102 can abut the tube flange 1410. The contact of the cap flange 1210 and the tube flange 1410 can thereby prevent the dispensing cap 1102 from further translation in the direction of the closed end 1408 of the tube body 1104. The contact of the cap flange 1210 can provide a tactile response to the user securing the dispensing cap 1102 to the closed end 1408 of the tube body 1104.

[0228] 4. Seals

[0229] In some embodiments, particularly those embodiments in which buffer fluid and / or reagents are stored within tube body 1104 for an extended period of time (e.g., days, weeks, months, and / or years) before filter tube assembly 1100 is used to filter a fluid containing a sample, a seal can be secured to the open end of tube body 1104. Figure 15A-15B Such a seal is illustrated. Fig.15A Filter tube assembly 1100 with seal 1502 is illustrated. Fig. 15B The figure shows a top view of the seal 1502. The seal 1502 can cover Fig.15A The open end 1406 of the tube body 1104 shown in the figure prevents evaporation, contamination, etc. of any buffer fluid and / or reagent contained in the tube body 1104. The seal 1502 can create a fluid-tight barrier between the internal volume 1414 of the tube body 1104 and the outside. As an illustrative example, the seal 1502 can be a foil heat-pressed seal. The seal 1502 can be heat-pressed to the tube flange 1410 to create a seal. Alternatively, an induction seal can be used to bond the seal 1502 to the tube flange 1410. Other bonding methods can be appropriately implemented. For example, the seal 1502 can be bonded to the tube flange 1410 using an adhesive. The seal 1502 can include a covering portion 1504 and a tab portion 1506. The covering portion 1504 can cover the open end 1406 of the tube body 1104. The tab portion 1506 can be grasped and pulled by a user, thereby allowing the seal 1502 to be removed from the tube body 1104. Advantageously, the seal 1502 can be removed from the tube body 1104 while minimizing the risk of a user contacting or contaminating any buffer fluid and / or reagents contained within the tube body 1104 .

[0230] 5. Assembly

[0231] Figure 16A-Figure 17 A cross-sectional view of a filter tube assembly 1100 is illustrated, showing the interaction of a dispensing cap 1102 , a tube body 1104 , and a filter 1108 . Fig.16A A cross-sectional side view of the filter tube assembly 1100 is illustrated, showing the filter 1108 inserted into the dispensing cap 1102 . Fig. 16B A cross-sectional side view of the filter tube assembly 1100 is illustrated, showing the filter 1108 positioned within the dispensing cap 1102 . Fig. 16C A cross-sectional side view of the dispensing cap 1102 is illustrated with the filter 1108 positioned inside and showing the path of fluid flow through the dispensing cap 1102 . Fig.17A cross-sectional side view of the filter tube assembly 1100 is illustrated with the dispensing cap 1102 having been attached to the open end 1406 of the tube body 1104 , and includes insets showing the interaction of the collar 1222 and the neck region 1402 .

[0232] like Fig.16A and Fig. 16B As shown, the filter 1108 can be positioned within the dispensing cap 1102 such that the distal surface 1306 of the filter 1108 abuts the distal surface 1218 of the dispensing cap 1102. The distal surface 1218 can contact the distal surface 1306, thereby preventing the filter 1108 from moving further toward the orifice 1202 of the dispensing cap 1102. The outer diameter 1308 of the filter 1108 can be approximately equal to or slightly larger than the diameter of the filter cavity 1216 of the dispensing cap 1102. Therefore, when located within the dispensing cap 1102, the filter 1108 can fit tightly within the filter cavity 1216. For example, the filter 1108 can engage the section 1606 of the inner wall of the dispensing cap 1102 by an interference fit. The fit of the filter 1108 may substantially prevent and / or inhibit movement of the filter 1108 within the dispensing cap 1102 when a user compresses the tube body 1104 to drive fluid containing a sample through the filter 1108 and out of the dispensing cap 1102 .

[0233] Fig. 16C The dashed arrow in the figure indicates the direction of fluid flow through the dispensing cap 1102 when the tube body 1104 of the filter tube assembly 1100 is compressed (e.g., in a distal direction away from the proximal end 1208 of the dispensing cap 1102). When the tube body 1104 of the filter tube assembly 1100 is compressed, the fluid containing the sample can flow from the interior space 1212 and / or the interior volume 1414 (which are fluidly connected), through the filter 1108, through the flow path 1204 (which includes the transition zone 1214, the middle portion 1604, and the distal portion 1602), and out of the orifice 1202.

[0234] As previously described, the transition region 1214 can reduce the back pressure (i.e., the high pressure in the interior space 1212 relative to the flow path 1204) acting on the filter 1108. The transition region 1214 provides a space with a diameter that is not much smaller than the outer diameter 1308 of the filter 1108. In some examples, the outer diameter 1308 of the filter 1108 is about 1.05, 1.10, 1.15, 1.20, 1.25, 1.30, 1.35, 1.40, 1.45, 1.50, 1.55, 1.60, 1.65, 1.70, 1.75, 1.80, 1.85, 1.90, 1.95, or 2.00 times larger than the diameter of the transition region 1214, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the outer diameter 1308 of the filter 1108 is approximately 1.2-1.6 times the diameter of the transition zone 1214. Additionally or alternatively, in some examples, the outer diameter 1308 of the filter 1108 is approximately 1.3-1.5 times the diameter of the transition zone 1214. Additionally or alternatively, in some examples, the outer diameter 1308 of the filter 1108 is approximately 1.35-1.45 times the diameter of the transition zone 1214. Additionally or alternatively, in some examples, the diameter of the filter 1108 is approximately 1.4 times the diameter of the transition zone 1214.

[0235] The shape and / or size of the distal portion 1602 and the middle portion 1604 of the flow path 1204 can also affect the pressure on the filter 1108. It may be desirable that the inner surface of the dispensing cap 1102 defining the middle portion 1604 (referred to as the curved portion 1608) includes a gradual curve so that the diameter of the flow path 1204 does not suddenly decrease from the transition zone 1214 to the distal portion 1602. The gradual change in the diameter of the flow path 1204 can ensure that the pressure of the fluid containing the sample does not increase or decrease sharply. The inner wall of the dispensing cap 1102 defining the distal portion 1602 can be shallowly inclined. In some embodiments, the diameter at the proximal portion of the distal portion 1602 (e.g., the portion near the middle portion 1604) is greater than the diameter of the orifice 1202.

[0236] 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 out of the filter tube assembly 1100 when the tube body 1104 is compressed. It may be desirable that the maximum flow rate be high enough so that the filter tube assembly 1100 can dispense the total volume of filtered sample-containing fluid for a molecular assay as previously described in no more than one, two, three, or four compressions of the tube body 1104. In some examples, the ratio a:v of the surface area of ​​the distal surface 1306 of the filter 1108 to the interior volume 1414 of the tube body 1104 can be about 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 m. -1 , or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the ratio a:v of the surface area of ​​the distal surface 1306 of the filter 1108 to the interior volume 1414 of the tube body 1104 is about 20 m -1 -40m -1 Additionally or alternatively, in some examples, the ratio a:v of the surface area of ​​the distal surface 1306 of the filter 1108 to the interior volume 1414 of the tube body 1104 is about 25 m -1 -35m -1 Additionally or alternatively, in some examples, the ratio a:v of the surface area of ​​the distal surface 1306 of the filter 1108 to the interior volume 1414 of the tube body 1104 is about 30 m -1The 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 the filter depth 1314, fluid may flow through the surface area of ​​the proximal surface 1304 of the filter 1108 at a higher flow rate than through the cup filter wall 1302. The portion of the distal surface 1218 that contacts the filter 1108 may impede flow through the contacting portion of the filter 1108. That is, in some embodiments, the surface area of ​​the filter 1108 available for fluid flow may be less than the surface area of ​​the distal surface 1306. In some examples, the ratio a:v of the proximal surface 1304 of the filter 1108 to the interior volume 1414 of the tube body 1104 can be about 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, or 36 m. -1 , or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges may be used in some cases. Additionally or alternatively, in some examples, the ratio a:v of the proximal surface 1304 of the filter 1108 to the interior volume 1414 of the tube body 1104 is about 10 m -1 -25m -1 Additionally or alternatively, in some examples, the ratio a:v of the proximal surface 1304 of the filter 1108 to the interior volume 1414 of the tube body 1104 is about 15 m -1 -20m -1 Additionally or alternatively, in some examples, the ratio a:v of the proximal surface 1304 of the filter 1108 to the interior volume 1414 of the tube body 1104 is about 17 m -1 .

[0237] Fig.17A cross-sectional view of a filter tube assembly 1100 according to an embodiment of the present disclosure is illustrated, wherein a dispensing cap 1102 is attached to a tube body 1104. When the dispensing cap 1102 is attached to the open end 1406 of the tube body 1104, the collar 1222 can engage with the neck region 1402 to create a fluid-tight barrier. The engagement between the collar 1222 and the neck region 1402 can result in the transmission of lateral forces, as indicated by the dashed arrows. The engagement between the collar 1222 and the neck region 1402 can be an interference fit. This interference fit can occur at the assembly portion 1710. The interference fit at the assembly portion 1710 can form a plug seal. The force applied by this interference fit can depend on the material of the tube body 1104 and the material of the dispensing cap 1102. The force applied by this interference fit can depend on the shape and / or size of the tube body 1104 and the dispensing cap 1102. The proximal collar thickness 1224 being less than the distal collar thickness 1226 allows the collar 1222 to extend further from the cap flange 1210, the greater the deflection of the collar 1222. The shape and size of the collar 1222 can be designed so that a user can attach the dispensing cap 1102 to the tube body 1104, and the engagement of the collar 1222 with the neck region 1402 is still sufficient to prevent and / or inhibit the dispensing cap 1102 from falling off the open end 1406 of the tube body 1104 when the user compresses the tube body 1104. The ridge 1228 of the dispensing cap 1102 and the ridge 1418 of the tube body 1104 can engage. The engagement of the ridges 1228 and 1418 can prevent and / or inhibit the dispensing cap 1102 from falling off the open end 1406 of the tube body 1104. When the dispensing cap 110 is attached to the tube body 1104, the proximal surface 1702 of the cap flange 1210 of the dispensing cap 1102 can abut the distal surface 1704 of the tube flange 1410 of the tube body 1104. The abutment of the proximal surface 1702 of the cap flange 1210 with the distal surface 1704 of the tube flange 1410 can prevent and / or inhibit movement of the dispensing cap 1102 toward the closed end 1408 of the tube body 1104. As discussed, in some embodiments, the cap flange 1210 need not abut the tube flange 1410 to confirm that an effective seal is formed between the dispensing cap 1102 and the tube body 1104. In such embodiments, there can be sufficient interference fit to form an effective seal between the dispensing cap 1102 and the tube body 1104 without abutting the cap flange 1210 and the tube flange 1410.

[0238] The shape, taper, and / or length of the collar 1222 can affect the force with which the dispensing cap 1102 is removed from the tube body 1104. The taper as discussed herein with reference to the collar 1222 can refer to a decrease in the thickness of the collar 1222 as the collar 1222 extends away from the cap flange 1210 (i.e., a decrease in the thickness of the collar 1222 as referenced). Fig.12D, the proximal collar thickness 1224 is less than the distal collar thickness 1226). The tapering as discussed herein with reference to the collar 1222 may additionally or alternatively refer to a decrease in the outer diameter of the collar 1222 as the collar 1222 extends away from the cap flange 1210 (i.e., with reference to Fig.12D , the proximal collar diameter 1234 can be less than the distal collar diameter 1236). For example, reducing the taper of the collar 1222 and / or increasing the length of the collar 1222 can, for example, increase the force to remove the dispensing cap 1102 from the tube body 1104. The taper on the collar 1222 paired with the shape of the neck region 1402 can help the user create an interference seal with the tube body 1104 with a gradually increasing force. In some embodiments, the gradually increasing force is configured to provide an ergonomic user experience, such as ensuring an efficient, reliable, and / or comfortable movement as the user couples the dispensing cap 1102 to the tube body 1104.

[0239] The shapes of ridges 1228 and 1418 can each affect the amount of force required to attach and / or remove the dispensing cap 1102 to the tube body 1104. For example, the shape and / or size of ridges 1228 and 1418 can each be changed to increase and / or decrease the force required to attach and / or remove the dispensing cap 1102 to the tube body 1104. When either or both of ridges 1228 and 1418 are relatively small (i.e., do not extend very far from the outer surface of collar 1222 or from the inner surface of neck region 1402, respectively), the force required to attach the dispensing cap 1102 to the tube body 1104 can be relatively low. Increasing the size of either or both of ridges 1228 and 1418 (i.e., the distance ridges 1228 extend from the outer surface of collar 1222 or the distance ridges 1418 extend from the inner surface of neck region 1402) can increase the force with which dispensing cap 1102 is attached to tube body 1104. In such an embodiment, sliding ridges 1228 past ridges 1418 can provide a user with tactile or audible feedback that dispensing cap 1102 is secured to tube body 1104 and / or a seal has been established.

[0240] In some examples, the force required to attach the dispensing cap 1102 to the tube body 1104 is no greater than about 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, or 150 N, or any value or range within or bounded by any of these ranges or values, but values ​​outside these values ​​or ranges may be used in some cases. In some examples, the force to attach the dispensing cap 1102 to the tube body 1104 is from about 20 N to 100 N. In some examples, the force to attach the dispensing cap 1102 to the tube body 1104 is no greater than about 60 N. In some examples, the force applied to attach the dispensing cap 1102 to the tube body 1104 may be less than the force applied to remove the dispensing cap 1102 from the tube body 1104. In some examples, the force applied to remove the dispensing cap 1102 from the tube body 1104 can be about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, or 150N, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the force applied to remove the dispensing cap 1102 from the tube body 1104 can be about 10N to 50N. Additionally or alternatively, in some examples, the force applied to remove the dispensing cap 1102 from the tube body 1104 can be about 20N to 40N. Additionally or alternatively, in some examples, the force applied to remove the dispensing cap 1102 from the tube body 1104 may be about 25N to 35N. Additionally or alternatively, in some examples, the force applied to remove the dispensing cap 1102 from the tube body 1104 may be about 30N. It may be desirable that the force to attach and remove the dispensing cap 1102 from the tube body 1104 is low enough so that a user can manually attach and / or remove the dispensing cap 1102. In some embodiments, the force to attach the dispensing cap 1102 to the tube body 1104 is such that a user can attach the dispensing cap 1102 to the tube body 1104 using one hand. It may be desirable that the force to remove the dispensing cap 1102 from the tube body 1104 is large enough so that the dispensing cap 1102 does not pop out during normal use of the filter tube assembly 1100.

[0241] Figures 18A-18D Illustrated is a series of steps for preparing a filter tube assembly 1100 for filtering a fluid containing a sample. Fig.18A Insertion of filter 1108 into dispensing cap 1102 is illustrated. Fig.18B The seal 1502 is illustrated removed from the tube body 1104 . Fig. 18CThe tube body 1104 is illustrated as being closed with a dispensing cap 1102 . Fig.18D Illustrated is a filter tube assembly 1100 in preparation for compression to filter a fluid containing a sample contained therein.

[0242] In preparing the filter tube assembly 1100 for use, the steps may optionally include inserting the filter 1108 into the dispensing cap 1102, such as Fig.18A The placement of the filter 1108 within the dispensing cap 1102 can be in accordance with the present disclosure. In some other embodiments, the filter tube assembly 1100 can be supplied to the user with the filter 1108 already positioned in the dispensing cap 1102.

[0243] In embodiments where the filter tube assembly 1100 includes the seal 1502, the user can remove the seal 1502. The user can remove the seal 1502 by, for example, grasping the tab portion 1506 and, for example, Fig.18B 1502. The seal 1502 can be removed by pulling upward as indicated by the dashed arrow in FIG. 1502. Once the seal 1502 is removed, the sample can be added to the tube body 1104.

[0244] After the sample is added to the tube body 1104, the tube body 1104 can be closed with the dispensing cap 1102. The arms 1106 can be bent and / or folded to allow the user to dispense the sample, such as by Fig. 18C The dispensing cap 1102 is placed on the tube body 1104 as indicated by the dashed arrow in FIG.

[0245] When dispensing cap 1102 is positioned on tube body 1104, the user can Fig.18D The side of the tube body 1104 is compressed as shown by the dashed arrows in FIG. The user can also invert the filter tube assembly 1100 to direct the filtered sample-containing fluid produced by the filter tube assembly 1100 to a container (e.g., a test device) for receiving the filtered sample-containing fluid.

[0246] D. Filter tube assembly with cup filter and separate tube body and dispensing cap

[0247] As previously mentioned, embodiments of the filter tube assembly according to the present disclosure may include a two-piece assembly. For example, in some embodiments, the filter tube assembly may include a dispensing cap and a tube body that are molded as separate components. Figure 19A-Figure 24 An example filter tube assembly 1900 that may be used to prepare samples for molecular assays according to embodiments of the present disclosure is illustrated in which a dispensing cap 1902 and a tube body 1904 are separate components. Fig.19A A perspective view of filter tube assembly 1900 is illustrated. Fig.19B A side view of filter tube assembly 1900 is illustrated. Fig.19CAn exploded perspective view of filter tube assembly 1900 is illustrated.

[0248] Fig.19D An oblique view of a filter tube assembly 1900 is illustrated. According to the present disclosure (e.g., with reference to filter tube assembly 1100), filter tube assembly 1900 can advance a volume of filtered sample-containing fluid in no more than one, two, three, or four compressions. It should be understood that filter tube assembly 1900 can include various features described herein according to the present disclosure, including the features described with reference to filter tube assembly 1100. Dispensing cap 1902 and tube body 1904 can be cast from different materials because they are separate components.

[0249] like Figures 19A-19D As shown, filter tube assembly 1900 may include dispensing cap 1902, tube body 1904, and arm 1906. Arm 1906 connects dispensing cap 1902 to tether ring 1910. Tether ring 1910 may be coupled to tube body 1904 so that dispensing cap 1902 and tube body 1904 are attached even when tube body 1904 remains open. In other embodiments, filter tube assembly 1900 may include two or more arms linking dispensing cap 1902 to tether ring 1910. Arm 1906 may include a notch that may allow arm 1906 to bend and / or fold.

[0250] like Figure 20A-Figure 20E As shown, the dispensing cap 1902 can include a collar 2022, an orifice 2002, a flow path 2004, a nozzle 2006, a proximal end 2008, a cap flange 2010, an interior space 2012, a transition zone 2014, a filter cavity 2016, a distal surface 2018, a cap body 2020, a ridge 2028, and a retaining tab 2034. As discussed with reference to the collar 1222, the thickness of the collar 2022 can be non-uniform and can taper as the collar 2022 extends from the cap flange 2010. In other words, the proximal collar thickness 2024 can be less than the distal collar thickness 2026. Additionally or alternatively, as discussed with reference to collar 1222, the diameter of collar 2022 can decrease as collar 2022 extends from cap flange 2010 toward proximal end 2008 (i.e., distal collar diameter 2030 can be greater than proximal collar diameter 2032). Diameters 2030 and 2032 can be sized in accordance with the present disclosure (e.g., with reference to diameters 1230 and 1232, respectively). Dispensing cap 1902 can engage filter 1108 in accordance with the present disclosure (e.g., as discussed with reference to dispensing cap 1102 and Figure 16A-16C2004 and / or transition zone 2014 may be sized and shaped in accordance with the present disclosure (e.g., see flow path 1204 and transition zone 1214). Filter 1108 (i.e., cup filter 1108) may be sized and shaped in accordance with embodiments of the present disclosure (e.g., see examples of embodiments of the present disclosure). Figures 13A-13D ). The retaining tab 2034 can be positioned adjacent to the filter cavity 2016. According to the present disclosure, the retaining tab 2034 can prevent or inhibit the filter 1108 from moving away from the filter cavity 2016. According to the present disclosure (e.g., reference Fig. 12B ), the ridge 2028 is defined by an upper slope 2036, a vertex 2038 and a lower slope 2040.

[0251] like Figure 21A-Figure 21D As shown, 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 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 designed in size, shape, include materials, and / or include functions according to the present disclosure (e.g., with reference to the tube body 1104). The teeth 2120 may be positioned on the outer surface of the tube body 1904. The teeth 2120 may be positioned closer to the open end 2106 than the closed end 2108. In some examples, the teeth 2120 are positioned near the tube flange 2110. There may be two, three, four or more teeth 2120 positioned along the perimeter of the outer surface of the tube body 1904. The teeth 2120 may be positioned on the outer surface of the neck region 2102 of the tube body 1904. Figure 21A-Figure 21D An embodiment is illustrated that includes four teeth 2120 positioned equidistantly around the circumference of the outer surface of the tube body 1904. The teeth 2120 can engage the tether loop 1910 of the dispensing cap 1102 (see Figure 25A-25B , which illustrates the positioning of the tether loop 1910 of the dispensing cap to the tooth 2120). According to the present disclosure (e.g., reference Fig. 14B ), the ridge 2118 is defined by an upper slope 2122, a vertex 2124 and a lower slope 2126.

[0252] Fig. 22A filter tube assembly 1900 is illustrated having a seal 1502. The seal 1502 can be in accordance with the present disclosure (e.g., with reference to the discussion regarding FIG. 15 and the filter tube assembly 1100). As an illustrative example, the seal 1502 can be a foil heat press seal. In another example, an induction seal is used to bond the seal 1502 to the tube flange 2110. Alternatively, in some embodiments, the filter tube assembly 1900 can include a travel cap that can create a fluid-tight barrier with the open end 2106 of the tube body 1904. Such a travel cap can be in accordance with the present disclosure (e.g., with reference to the discussion regarding the travel cap 902).

[0253] Fig.23A 108 is shown placed within the dispensing cap 1902. The dispensing cap 1902 may include an orifice 2002, a flow path 2004, a nozzle 2006, a proximal end 2008, a transition zone 2014, a filter cavity 2016, a cap body 2020, a distal surface 2018, and a retaining tab 2034. Fig.16A and Fig. 16B 1902 ), filter 1108 may be positioned within dispensing cap 1902 . Fig. 23B The filter 1108 is shown positioned within the dispensing cap 1902, and the flow of liquid from the interior space 2012 through the filter 1108 to the flow path 2004 is shown. The orifice 2002, the flow path 2004, the nozzle 2006, the distal portion 2302, the curved portion 2306, the intermediate portion 2304, and the transition zone 2014 can be configured according to embodiments of the present disclosure (e.g., with reference to Fig. 16C and discussion of allocation cap 1102).

[0254] In some embodiments, the internal volume 2114 of the tube body 1904 can be reduced so that the fluid containing the sample is pushed from the filter tube assembly 1900 to the test device, for example, so as to perform molecular determinations, such as but not limited to nucleic acid 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 base region 2104) is flexible enough to allow the user to compress the wall 2116 of the tube body 1904, thereby pushing one or more streams of the filtered fluid containing the sample to the test device through the orifice 2002 of the distribution cap 1902. One or more streams can be continuous streams of the fluid pushed through the orifice 2002. Flexibility can be produced by a combination of the thickness of the wall 2116 and the modulus (e.g., Young's modulus) of the material included in the tube body 1904. For example, the thickness 2112 of the wall 2116 can be less than the thickness of the portion of the distribution cap 1902. This combination of the 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 can have a thin section extending axially and / or radially in the wall 2116, which gives the tube body 1904 a hinge point at which the wall 2116 can bend while other parts of the wall 2116 are thicker and / or harder. The user can then compress the tube body 1904, which bends at the thin hinge point, thereby reducing the internal volume 2114 and pushing the fluid containing the sample out through the filter 108 and the flow path 2004 and out of the orifice 2002 of the dispensing cap 1902 without requiring the entire wall 2116 to be thin enough to bend. Other configurations of pushing a stream or other volume of fluid containing the sample from the tube body 1904 through the dispensing cap 1902 are possible. In other embodiments, the tube body 1904 may not require compression or squeezing to dispense fluid from a container, and may dispense droplets of fluid when the filter tube assembly 1900 is inverted.

[0255] In some embodiments, the thickness of the material of the tube body 1904 at the tube flange 2110 can 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 can be equal to or greater than the thickness 2112 of the wall 2116. In some examples, the thickness 2112 of the wall 2116 can be approximately 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.05, 1.1, 1.15, 1.2, or 1.25 mm, or any value or range within or bounded by any of these ranges or values, although values ​​outside of these values ​​or ranges can be used in some cases. Additionally or alternatively, in some examples, the thickness 2112 is approximately 0.60 mm to 0.90 mm. Additionally or alternatively, in some examples, thickness 2112 is approximately 0.70 mm to 0.80 mm.

[0256] Fig.24 The interaction of the dispensing cap 1902 and the tube body 1904 is illustrated. The dispensing cap 1902 may include a collar 2022 that may create a fluid-tight barrier against the neck region 2102 of the tube body 1904. The interaction of the collar 2022 and the neck region 2102 may be implemented in accordance with embodiments of the present disclosure (e.g., in accordance with the disclosure regarding Fig.17 1904). The collar 2022 can contact the inner perimeter of the open end 2106 of the tube body 1904, thereby creating a fluid-tight seal. When the dispensing 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 can be as shown by Fig.24 1904. When the dispensing cap 1902 is attached to the open end 2106 of the tube body 1904, the proximal surface 2402 of the cap flange 2010 can abut the distal surface 2404 of the tube flange 2110. In some embodiments, the cap flange 2010 does not need to abut the tube flange 2110 to confirm that an effective seal is formed between the dispensing cap 1902 and the tube body 1904. In such embodiments, there can be enough interference fit to form an effective seal between the dispensing cap 1902 and the tube body 1904 without abutting the cap flange 2010 and the tube flange 2110. This interference fit can occur at the assembly portion 2406. The interference fit at the assembly portion 2406 can form a plug seal.

[0257] Figure 25A-Figure 25D Illustrated is a series of steps for preparing a filter tube assembly 1900 for filtering a fluid containing a sample. Fig.25AInsertion of filter 1108 into dispensing cap 1902 and attachment of dispensing cap 1902 to tube body 1904 via tether loop 1910 and arm 1906 are illustrated. Fig.25B The seal 1502 is illustrated removed from the tube body 1904 . Fig.25C The tube body 1904 is illustrated as being closed with a dispensing cap 1902 . Fig.25D Illustrated is a filter tube assembly 1900 in preparation for compression to filter a fluid containing a sample contained therein.

[0258] In preparing the filter tube assembly 1100 for use, steps may optionally include inserting the filter 1108 into the dispensing cap 1102 and / or attaching the dispensing cap 1902 to the tube body 1904 via the arms 1906 and the tube body 1904, as shown in FIG. Fig.25A As shown. The placement of the filter 1108 in the dispensing cap 1102 can be in accordance with the present disclosure. The tether loop 1910 can surround the perimeter of the tube body 1904 and engage with the teeth 2120. In some other embodiments, the filter tube assembly 1900 can be supplied to the user with the filter 1108 already positioned in the dispensing cap 1102. In some embodiments, the filter tube assembly 1900 can be supplied to the user with the dispensing cap 1902 already coupled to the tube body 1904 via the arm 1906 and the tether loop 1910.

[0259] In embodiments where filter tube assembly 1900 includes seal 1502, a user may remove seal 1502. The user may remove seal 1502 by, for example, grasping tab portion 1506 and, for example, Fig.25B 1904. Pull upward as indicated by the dashed arrow in to remove the seal 1502. Once the seal 1502 is removed, the sample can be added to the tube body 1904.

[0260] After the sample is added to the tube body 1904, the tube body 1904 can be closed with the dispensing cap 1902. The arms 1906 can be bent and / or folded to allow the user to dispense the sample, such as by Fig.25C The dispensing cap 1902 is placed on the tube body 1904 as indicated by the dashed arrow in FIG.

[0261] When the dispensing cap 1902 is positioned on the tube body 1904, the user can Fig.25D The side of the tube body 1904 is compressed as indicated by the dashed arrows in FIG. The user can also invert the filter tube assembly 1900 to direct the filtered sample-containing fluid produced by the filter tube assembly 1900 to a container (e.g., a test device) for receiving the filtered sample-containing fluid.

[0262] E. Methods of Preparing Sample Fluid

[0263] Fig.26 An example method 2600 of preparing a sample for molecular assay using a filter tube assembly according to the present disclosure is illustrated.

[0264] At step 2602, the sample is introduced into the buffer, thereby creating a fluid containing the sample. In certain embodiments, when the sample is introduced into the buffer, the buffer can be located in the pipe body of the filter tube assembly. In certain embodiments, the sample can be introduced into the buffer at a position other than the pipe body of the filter tube assembly. In such an embodiment, the user can distribute the fluid containing the sample to the pipe body of the filter after the sample has been introduced into the buffer.

[0265] At step 2604, the distribution cap is attached to the pipe body. In some embodiments, the distribution cap is attached to the pipe body and includes a snap-fit ​​feature (e.g., ridges and / or recesses) that engages the distribution cap and the pipe body. In such embodiments, the snap-fit ​​feature (e.g., ridges and / or recesses) can provide the user with a sense of touch or audible feedback that the distribution cap is fixed to the pipe body. In such embodiments, the engagement snap-fit ​​feature can create a fluid-tight seal between the distribution cap and the pipe body. In some embodiments, the distribution cap is attached to the pipe body and includes engaging the collar of the distribution cap with the open end of the pipe body, thereby creating a fluid-tight seal (e.g., a plug seal).

[0266] At step 2606, the tube body is compressed. Compressing the tube body can advance the fluid containing the sample contained in the tube body through the filter located in the distribution cap. After passing through the filter, the fluid containing the sample can be pushed out of the distribution cap. In some embodiments, the user can compress the tube body no more than 1, 2, 3 or 4 times to advance the filtered fluid containing the sample of the desired volume from the filter tube assembly. In some embodiments, the filtered fluid containing the sample is advanced from the filter tube assembly to a test device, such as a test device for performing a molecular assay.

[0267] Example

[0268] Example 1. Filter effectiveness

[0269] Testing was performed to determine the sensitivity of the assay for filtered sample-containing fluids. Figure 1A-Figure 7 The filter tube assembly of the embodiment, each filter tube assembly includes one of several different types of filter materials as the filter 102. Table 1 lists the reactivity of various filters, and the various filters include HDC40, HDC5 and HDC20 (LA1244) (melt-blown polypropylene filter of Pall Corporation (Port Washington, NY)); filters (hydrophobic PTFE filters from MilliporeSigma (Burlington, Massachusetts) (hereinafter "Omnipore")); Poly45 μM (hydrophobic polypropylene filters from MilliporeSigma); and VividACG (in BD Veritor TM Hydrophilic glass fiber filters from Pall Corporation provided in the At-Home COVID-19 test, FluA+B Rapid Antigen test, and RSV RapidAntigen test (Becton Dickinson, Franklin Lakes, New Jersey) (hereinafter "Veritor filter"). The filter is used to prepare a sample-containing fluid for an assay to measure the presence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and an internal control (IC). The reactivity of the unfiltered sample is also listed. The detection time (Td) is a measure of the amplification time in minutes. A higher Td may be due to inhibition of the assay by an inhibitor. Therefore, a lower Td may indicate that the filter in the test removes a greater portion of the inhibitor from the sample-containing fluid than the unfiltered sample-containing fluid.

[0270] Table 1. Reactivity and Td

[0271]

[0272] For each of the three assay types, all tested filter materials had higher reactivity than the unfiltered sample. Thus, embodiments of filter tube assemblies according to the present disclosure exhibit improved assay reactivity and sensitivity relative to unfiltered sample-containing fluids.

[0273] 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, where OD600 refers to the optical density of the sample-containing fluid measured at a wavelength of 600 nm. The HDC40, HDC5, HDC20, and Veritor filters among the filter types produced filtered sample-containing fluids with OD600s that were significantly different from the OD600 of the unfiltered sample-containing fluid at p=0.05.

[0274] Table 2. Turbidity at OD600

[0275] Filter Type Average OD600 HDC40 0.038 HDC5 0.057 HDC20 0.046 Omnipore 0.192 Poly45μM 0.309 Veritor Filter 0.042 Unfiltered 0.415

[0276] Without being bound by a particular theory, it is believed that lower OD600 indicates more potential inhibitors are removed by the filter of the filter tube assembly according to the present disclosure. Turbidity was shown to correlate with assay sensitivity for both CT and GC assays at p=0.05.

[0277] Example 2. Efficacy of sintered polyethylene filters

[0278] Tests were performed to determine the effect of several different types of filter materials on the sensitivity of the assay. Table 3 lists the reactivity of the following sintered polyethylene filters from Porex Corporation (Richmond, Virginia): Porex 120, Porex 266, Porex 269, and Porex 595. Veritor filters (hydrophilic glass fiber filters) were also tested. The filters were compared with the Figure 1A-Figure 7 The filter tube assembly of the embodiment of the invention was used together to perform an assay measuring the presence of CT, GC and an internal control (IC). The reactivity of the unfiltered sample is also listed.

[0279] Table 3. Reactivity and Td

[0280]

[0281]

[0282] Fig. 27 The optical density (OD600) of the sample-containing fluid filtered by each of the five filters tested using the filter tube assembly according to the present disclosure at a wavelength of 600 nm and the OD600 of the unfiltered sample-containing fluid are plotted. Each filter reduces the OD600 relative to the unfiltered sample-containing fluid.

[0283] Fig.28 is a box plot of the concentration of human genomic DNA (hugDNA) measured by qPCR in sample-containing fluids filtered by each of the five filters tested using the filter tube assembly according to the present disclosure and the concentration of hugDNA in unfiltered sample-containing fluids. Fig.28 Each filter type tested is shown to reduce hugDNA compared to unfiltered sample-containing fluid.

[0284] Example 3. Filtering urine samples

[0285] Three different urine samples found to be inhibitory to the CT, GC, and / or IC Archaeal Polymerase Amplification (APA) assays were tested with and without filtration. These urine samples were filtered prior to being subjected to the assay using a filter tube assembly with a Porex 120 filter according to the present disclosure.

[0286] Fig.29A , Fig.29B and Fig.29C The fluorescence of the CT, GC and IC assays are plotted separately. The solid line indicates the fluorescence of the filtered sample, while the dashed line indicates the fluorescence of the unfiltered sample. For all three assays, filtering improved amplification. Fig.29C As shown in the IC assay, amplification was rescued. In particular, the unfiltered sample used in the internal control assay did not amplify, while the increase in fluorescence of the filtered sample indicated successful amplification of the filtered sample.

[0287] Example 4. Filtration of samples for Trichomonas vaginalis assay

[0288] Trichomonas vaginalis (TV) is a parasite that causes infection. TV trophozoites are 7 μm-30 μm long, which ranges from about 20-100 times larger than many types of bacteria. If present, TV can be detected in vaginal swab samples. When filtering a sample in preparation for a molecular assay (e.g., filtering using a filter tube assembly according to the present disclosure), it may be desirable that the filter not remove TV trophozoites (thereby including or reducing assay sensitivity).

[0289] Samples containing known amounts of TV were filtered according to embodiments of the present disclosure. In particular, BDMAX TM The CTGCTV2 assay (Becton Dickinson, Franklin Lakes) was used as a model for measuring the relative cycle threshold (Ct) of TV samples before and after filtration using a filter tube assembly according to the present disclosure, with GC as a control. The filter tube assembly according to the present disclosure (including a Porex 120 filter) was used to filter a 1×10 5 1 mL of BDMAX with a TV concentration of trophozoites / mL TM buffer. The other has 1×10 5 1 mL of BDMAX with a TV concentration of trophozoites / mL TM The buffer was tested in parallel as an "unfiltered" sample. A filter tube assembly according to the present disclosure (including a Porex 120 filter) was used to filter a 1×10 4 cfu / mL GC concentration of 1mL BDMAX TM buffer. The other has 1×10 4cfu / mL GC concentration of 1mL BDMAX TM The buffer was tested in parallel as an "unfiltered" sample.

[0290] Filtered and unfiltered TV buffer and GC buffer solutions were subjected to amplification assays. Fig.30 The average Ct scores for these samples are plotted, with error bars indicating standard deviation. There was no significant difference in Ct between unfiltered and filtered TV samples. There was no significant difference between unfiltered and filtered GC samples. These results indicate that relatively large parasites, such as TV, are not removed during filtration of vaginal samples using a filter tube assembly according to the present disclosure.

[0291] the term

[0292] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0293] Conjunctive language, such as the phrase "at least one of X, Y, and Z," is understood in context, unless expressly stated otherwise, to be generally used to convey that an item, term, etc. may be X, Y, or Z. Thus, such conjunction language is generally not intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0294] As used herein, language of degree (such as, as used herein, the terms "approximately," "about," "generally," and "substantially") refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic and still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" may refer to an amount that is within less than 10%, within less than 5%, within less than 1%, within less than 0.1%, and within less than 0.01% of a stated amount.

[0295] As used herein, the term "and / or" has its broadest least restrictive meaning that includes A alone, B alone, A and B together, or A or B, but does not require both A and B or require one of A or one of B. As used herein, the phrase "at least one of" A, B, and C should be construed to mean a logical A or B or C, using a non-exclusive logical or.

[0296] Unless otherwise expressly stated, or understood otherwise in the context of use, conditional language as used herein (such as "may", "can", "possibly", "can", etc.) is generally intended to convey that certain features, elements and / or steps are optional. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are required in any way. The terms "include", "comprise", "have", etc. are used inclusively in an open-ended manner, and additional elements, features, actions, operations, etc. are not excluded. In addition, the term "or" is used in its inclusiveness (rather than exclusivity), so that, for example, when used to connect a list of elements, the term "or" represents one, some or all of the elements in the list. In addition, the term "each" as used herein, in addition to having its ordinary meaning, can also mean any subset of the set of elements to which the term "each" is applied.

[0297] Any method disclosed herein need not be performed in the order described.The methods disclosed herein include certain actions taken by a practitioner; however, they may also include any third-party instructions for such actions, whether explicit or implicit.

[0298] Although the above detailed description has shown, described and pointed out novel features, it is understood that various omissions, substitutions and modifications can be made in the described forms and details of the devices, systems and methods without departing from the spirit of the present disclosure. For example, the features discussed in the various example embodiments can be interchangeable to the extent that they are compatible. It can be appreciated that some parts described herein can be embodied in a form that does not provide all the features and benefits set forth herein, because some features can be used or practiced separately from other features. Therefore, the present disclosure is not limited to the specific embodiments disclosed herein, but covers all modifications and alternatives that fall within the true scope and spirit of the present disclosure.

Claims

1. A filter tube assembly for preparing a sample-containing fluid for use with a molecular assay, characterized in that The components include: a dispensing cap comprising a flow path and an orifice, a filter positioned within the dispensing cap; and A tube body, the tube body comprising an open end and a closed end, the tube body being configured to contain a sample-containing fluid, the dispensing cap being configured to be secured to the open end of the tube body, at least a portion of the tube body comprising a flexible material, the flexible material being configured to be compressed to force at least a portion of the sample-containing fluid through the filter, the flow path, and the orifice when the dispensing cap is secured to the open end of the tube body and the flexible material is compressed, the dispensing cap being configured to propel 2.5 mL to 3.0 mL of filtered sample-containing fluid through the orifice in a continuous flow during no more than two compressions of the flexible material.

2. The filter tube assembly according to claim 1, characterized in that Wherein the filter tube assembly is configured to advance a continuous flow of at least 1 mL of filtered sample-containing fluid through the orifice upon a single compression of the tube.

3. The filter tube assembly according to claim 1 or 2, characterized in that: Wherein the flow path includes a transition zone positioned proximate the filter, the transition zone being configured to reduce back pressure on the filter upon compression of the flexible material.

4. The filter tube assembly according to claim 3, characterized in that The diameter of the filter is from 1.2 to 1.6 times greater than the diameter of the transition zone.

5. The filter tube assembly according to claim 4, characterized in that The diameter of the transition zone is between 8 mm and 12 mm.

6. The filter tube assembly according to any one of claims 1-2 and 4-5, characterized in that: A retaining ring is included and is configured to secure the filter to the dispensing cap.

7. The filter tube assembly according to claim 6, characterized in that Wherein the retaining ring includes a groove configured to matingly engage a ridge of the inner surface of the dispensing cap.

8. The filter tube assembly according to any one of claims 1-2 and 4-5, characterized in that: Wherein the filter is a cup-style filter, the cup-style filter includes a wall configured to secure the filter to the dispensing cap.

9. The filter tube assembly according to any one of claims 1-2, 4-5 and 7, characterized in that: The hardness of the material of the dispensing cap is greater than the hardness of the material of the tube body.

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

11. The filter tube assembly according to any one of claims 1-2, 4-5, 7 and 10, characterized in that Wherein the Young's modulus of the material of the dispensing cap is at least 800 MPa.

12. The filter tube assembly according to any one of claims 1-2, 4-5, 7 and 10, characterized in that The Young's modulus of the material of the tube body is from 200 MPa to 300 MPa.

13. The filter tube assembly according to any one of claims 1-2, 4-5, 7 and 10, characterized in that The dispensing cap comprises high density polyethylene (HDPE) or polypropylene.

14. The filter tube assembly according to any one of claims 1-2, 4-5, 7 and 10, characterized in that The tube main body material comprises linear low density polyethylene (LLDPE).

15. The filter tube assembly according to any one of claims 1-2, 4-5, 7 and 10, characterized in that The dispensing cap also includes a tether ring configured to engage an exterior of the tube body.

16. The filter tube assembly according to any one of claims 1-2, 4-5, 7 and 10, characterized in that Also included is a traveling cap configured to be secured to the open end of the tube body, the traveling cap including a collar configured to inhibit leakage of fluid from the interior volume of the tube body when the traveling cap is secured to the open end of the tube body.

17. The filter tube assembly according to claim 16, characterized in that Wherein the traveling cap includes a threaded portion configured to engage a threaded portion of the pipe body.

18. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein the dispensing cap includes a threaded portion configured to engage a threaded portion of the tube body.

19. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein the tube body is at least partially transparent to visible light.

20. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein at least a portion of the wall of the tube body has a thickness between 0.2 mm and 1.0 mm.

21. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein the filter comprises a plurality of openings having a diameter between 1 μm and 250 μm.

22. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that The filter comprises polyethylene, glass fiber, polypropylene or polytetrafluoroethylene.

23. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein the tube body has an internal volume between 3 mL and 5 mL.

24. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that The tube body is configured to contain from 2.5 mL to 3.5 mL of fluid containing a sample.

25. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein the tube body is configured to include a headspace volume of at least 2 mL when the sample-containing fluid is present in the tube body.

26. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that Wherein the orifice comprises a diameter, and wherein the diameter is between 2.8 mm and 3.2 mm.

27. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10 and 17, characterized in that wherein the filter is configured to filter molecules that enter through a first surface of the filter and exit through an opposite second surface of the filter, and wherein the surface area of ​​the first surface of the filter is from 100 mm 2 Up to 200mm 2 .

28. The filter tube assembly according to claim 27, characterized in that The ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body is within 20 m -1 Up to 40m -1 between.

29. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17 and 28, characterized in that The tube body further comprises a snap-fit ​​ridge configured to matingly engage with the recess of the dispensing cap and a flange configured to contact the proximal end of the dispensing cap.

30. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17 and 28, characterized in that Wherein the force required to attach the dispensing cap to the tube body is from 20N to 100N.

31. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17 and 28, characterized in that Wherein the force required to remove the dispensing cap from the tube body after snap-fit ​​is at least 30N.

32. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 17 and 28, characterized in that Wherein the tube body and dispensing cap are molded as a single piece of plastic, and wherein the filter tube assembly includes at least one tether connecting the tube body to the dispensing cap.

33. The filter tube assembly according to claim 32, characterized in that Wherein the plastic of the tube body and dispensing cap has a Young's modulus between 200 MPa and 700 MPa.

34. The filter tube assembly of claim 32, wherein: A seal is included covering the open end of the tube body.

35. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17, 28 and 33-34, characterized in that Wherein the tube body includes a fill line indicating a minimum volume amount for use in the molecular assay.

36. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17, 28 and 33-34, characterized in that Also included is a buffer contained within the interior volume of the tube body.

37. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17, 28 and 33-34, characterized in that Wherein the filter is configured to prepare a fluid containing a sample for use in a gonorrhea assay, a chlamydia assay, or a trichomoniasis assay.

38. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17, 28 and 33-34, characterized in that wherein the molecular assay is a point-of-care molecular assay.

39. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17, 28 and 33-34, characterized in that Wherein the dispensing cap further comprises a collar, and the tube body comprises a neck region configured to engage the collar of the dispensing cap to form a fluid-tight seal, wherein the collar and the neck region are configured to engage via an interference fit.

40. The filter tube assembly of claim 39, wherein: Wherein the thickness of the wall at the proximal end of the collar of the dispensing cap is less than the thickness of the wall at the distal end of the collar of the dispensing cap.

41. The filter tube assembly of claim 39, wherein: Wherein an outer diameter of a wall at a proximal end of the collar of the dispensing cap is smaller than an outer diameter of a wall at a distal end of the collar of the dispensing cap.

42. The filter tube assembly of claim 39, wherein: Wherein the collar of the dispensing cap includes a first ridge and the neck region of the tube body includes a second ridge, the first ridge and the second ridge being configured to slidingly engage.

43. The filter tube assembly of claim 39, wherein: Wherein the tube body further includes a base portion positioned proximate the closed end of the tube body, the base portion including a diameter that is smaller than a diameter of the neck region.

44. The filter tube assembly according to any one of claims 1-2, 4-5, 7, 10, 17, 28, 33-34 and 40-43, characterized in that Wherein the dispensing cap comprises one or more retaining tabs configured to retain the filter within the dispensing cap.

45. A filter tube assembly for preparing a sample-containing fluid for use with a molecular assay, characterized in that The components include: a dispensing cap comprising a flow path and an orifice, the flow path comprising a transition zone, a filter positioned within the dispensing cap, the filter having a diameter that is 1.2 to 1.6 times greater than a diameter of the transition region of the flow path; and A tube body, the tube body comprising an open end and a closed end, the tube body being configured to contain a fluid containing a sample, the dispensing cap being configured to be fixed to the open end of the tube body, at least a portion of the tube body comprising a flexible material, the flexible material being configured to be compressed when the dispensing cap is fixed to the open end of the tube body and the flexible material is compressed to force at least a portion of the fluid containing the sample to pass through the filter, the flow path and the orifice, the dispensing cap being configured to advance a continuous flow of filtered fluid containing the sample through the orifice.

46. ​​The filter tube assembly of claim 45, wherein: Wherein the diameter of the filter is in the range from 12 mm to 16 mm, and the diameter of the transition zone is in the range from 8 mm to 12 mm.

47. A filter tube assembly for preparing a sample-containing fluid for use with a molecular assay, characterized in that The components include: a dispensing cap comprising a flow path and an orifice, A filter positioned within the dispensing cap, the filter configured to filter molecules from a fluid containing a sample that enters through a first surface of the filter and exits through a second surface of the filter, the filter having a surface area of ​​100 mm 2 and 200mm 2 between; and A tube body, the tube body comprising an open end and a closed end, the tube body being configured to contain the sample-containing fluid in an internal volume, the dispensing cap being configured to be fixed to the open end of the tube body, at least a portion of the tube body comprising a flexible material, the flexible material being configured to be compressed when the dispensing cap is fixed to the open end of the tube body and the flexible material is compressed to force at least a portion of the sample-containing fluid to pass through the filter, the flow path and the orifice, the dispensing cap being configured to advance a continuous flow of filtered sample-containing fluid through the orifice.

48. The filter tube assembly of claim 47, wherein: wherein the ratio a:v of the surface area of ​​the first surface of the filter to the internal volume of the tube body is within 20 m -1 Up to 40m -1 between.

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