Biological specimen collection and delivery system

JP2025506025APending Publication Date: 2025-03-05MATERIALS & MASCH CORP OF AMERICA
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Patent Information

Application Number
JP2024547254
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-02-08
Filing Date
2023-02-07
Publication Date
2025-03-05

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Abstract

A biological sample collection system and a delivery system are described. The biological sample collection system provides for collection and processing of a biological sample (i.e., bodily fluids collected from the nose, throat, or other mucous membranes of an animal or human). The biological sample collection system includes a sample collector and a collection tube. The sample collector provides structure for sealing the biological sample in the collection tube for further processing without opening the collection tube, and may provide structure for collecting the biological sample. When the sample collector and the collection tube are removably attached, a delivery system is formed. The delivery system provides for further processing of the biological sample without opening the collection tube (i.e., without unlocking or removing the plug from the collection tube). The delivery system further provides for delivery of the processed biological sample without opening the collection tube.
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Description

[Technical field]

[0001] This application claims the benefit of U.S. Non-provisional Application No. 17 / 667,158, entitled "BIOLOGICAL SAMPLE COLLECTION AND DISPENSING SYSTEM," filed February 8, 2022, which is incorporated by reference in its entirety. [Background technology]

[0002] Swabs are commonly used in the collection of biological samples for diagnostic analysis. A conventional swab, commonly referred to as a collection swab, may consist of a thin, cylindrical piece of plastic or wood, with one end used to hold the swab through the user's hand (the handle end) and the other end for collecting the biological specimen. The specimen collection end (collection end) generally includes a nylon, cotton, or similar absorbent material (the tip) attached to aid in specimen collection.

[0003] Conventional collection swabs are available in many forms and shapes and are made from many different types of materials. The collection tip is made from some hydrophilic material (such as cotton or nylon) that is glued to a plastic or wood material. After collection of the biological sample, the collection swab is usually immersed in a transport or culture medium in a container (tube) so that the collected material can be safely and stably maintained or transported for downstream applications. Other collection swabs are used to collect and store biological samples in a dry form. These conventional collection swabs are described in EP0643131, WO2004 / 086979 and U.S. Pat. No. 5,091,316.

[0004] A representative conventional swab and collection tube are shown in Figures 1a and 1b. The representative conventional swab 100 is made from plastic (e.g., polystyrene) and has a collection end 101 and a handle end 102. The collection end has a tip 103, such as one that is flocked with nylon or polyester fibers. The diameter of the collection end is approximately 0.2 inches (5.08 mm). The handle end 102 has a larger diameter than the collection end 101.

[0005] Additionally, a typical conventional swab has a break point 104 that allows the swab to be cut after sample collection and placing the collection end into a tube or collection device (see FIG. 1b). A typical conventional swab is approximately 6 inches (152.4 mm) in length, with the break point approximately midway (i.e., about 2-3 inches (50 mm-80 mm)) from the end of the tip 103.

[0006] The break point of the conventional swab corresponds to a collection tube that receives the collection end of the conventional swab. A conventional collection tube 150 is shown in FIG. 1b. A representative conventional collection tube includes a tube 105 and a lid 106. As shown in FIG. 1b, a representative conventional swab is received by the tube 105, and the representative conventional swab is cut at the break point 104 such that the collection end 103 is within the tube 105 and the handle end 102 is discarded. The lid 106 is screwed onto the tube 105 and the biological sample is now collected and available for downstream applications.

[0007] The collection tube may contain a liquid medium to maintain the collected biological sample in a stable and viable condition. Figure 1b shows a collected swab in liquid medium 107. Generally, conventional collection tubes have a waterproof lid, which may be a snap on cap, or a screw in or screw on lid.

[0008] Conventional collection swabs and conventional collection tubes do not have the ability to further process the biological sample without opening the collection tube. Rather, conventional collection swabs and conventional collection tubes serve only as containers for storing and shipping the biological sample for further analysis, such as processing that yields molecular or protein-based information from the host from which the biological sample was collected or from pathogens (viruses, bacteria, fungi, etc.) present in or associated with the biological sample.

[0009] Furthermore, conventional collection swabs and conventional collection tubes do not have the ability to further process the biological sample without opening the collection tube. As used herein, "without opening the collection tube" means that the plug sealing the collection tube is not removed or disengaged from the tube, but rather remains in place.

[0010] It is therefore desirable for the collection swab to be received by the collection tube for further processing without opening the collection tube. It is further desirable for the received collection swab and tube to allow for delivery of a processed sample without opening the collection tube. Summary of the Invention

[0011] In an aspect, a sample collector for collecting a biological sample includes a plug for sealing a collection tube, the plug including an attachment mechanism for removably attaching the plug to the collection tube, the attachment mechanism being under a ridge, the ridge having a diameter larger than the body of the plug and generally at the center of the plug, and a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out; a collection end, the collection end attached to a bottom of the plug, the collection end including a swab for biological sample collection; and a handle, the handle attached to a top of the plug, the handle including a cut point for removing the handle.

[0012] In an aspect, a biological sample collection system for containing a biological sample includes: a plug for sealing a collection tube, the plug including an attachment mechanism for removably attaching the plug to the collection tube, the attachment mechanism being below a ridge, a ridge having a diameter larger than a body of the plug and generally at the center of the plug, and a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out; a handle, the handle attached to a top of the plug and including a cut point for removing the handle; and a collection tube configured to receive the plug, the sample collection tube being a flexible plastic material, the sample collection tube including a flexible tube configured to hold a liquid and a receiving portion that is a material less flexible than the flexible tube, the receiving portion configured to receive the plug via the receiving mechanism, the receiving mechanism being complementary to the attachment mechanism below the ridge.

[0013] In an aspect, a biological sample delivery system for delivering a biological sample includes a plug for sealing a collection tube, the plug including an attachment mechanism for removably attaching the plug to the collection tube, the attachment mechanism being under a ridge, a ridge having a diameter larger than a body of the plug and generally at the center of the plug, and a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out, a collection end, the collection end attached to a lower portion of the plug and including a swab for biological sample collection, and a collection tube removably attached to the plug, the sample collection tube including a flexible tube configured to hold a liquid, the flexible tube being a flexible plastic material, and a receiving portion that is a material less flexible than the flexible tube, the receiving portion configured to receive the plug via the receiving mechanism, the receiving mechanism being complementary to the attachment mechanism under the ridge of the plug.

[0014] In an embodiment, a method for collecting and processing a biological sample with a biological sample and delivery system includes collecting a biological sample using a sample collector, the sample collector including a plug for sealing a collection tube, the plug including an attachment mechanism configured to removably attach the plug to the collection tube, the attachment mechanism being below a ridge, the ridge having a diameter greater than the body of the plug and generally at the center of the plug, and a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out to deliver a controlled amount of liquid of 20-40 milliliters per drop, a collection end, the collection end attached to a bottom of the plug, the collection end including a swab for biological sample collection, a handle, the handle attached to a top of the cap, the handle including a cut point for removing the handle, and a cap, the cap being removable by removably attachment to the plug via a cap fastening mechanism. a cap configured to seal the collection tube by sealing the plug with a plug attachment feature, the attachment feature of the plug being further over the ridge, the cap securing feature being complementary to the attachment feature, and the cap including a first orifice for dispensing the biological sample when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; collecting a biological sample; inserting the biological sample into the collection tube; removably attaching a sample collector to the collection tube, the collection tube including a flexible tube configured to hold a liquid, the flexible tube being a flexible plastic material, and a receiving portion being a material less flexible than the flexible tube, the receiving portion configured to receive the plug via the receiving feature, the receiving feature being complementary to the attachment feature below the ridge; removably attaching the sample collector to the collection tube; removing a handle from the sample collector to form a biological sample dispensing system; and dispensing the biological sample through the dispensing orifice when the cap is in the dispensing position. [Brief description of the drawings]

[0015] [Figure 1a] FIG. 1 is a diagram of a representative conventional collection swab. [Figure 1b] FIG. 1 is a diagram of a typical conventional collection tube receiving a typical conventional collection swab. [Figure 2a] FIG. 1 illustrates a sample collector of a biological sample collection system. [Figure 2b] FIG. 13 depicts the collection end and plug of the sample collector. [Figure 2c] FIG. 1 is a top down view of the plug. [Figure 2d] FIG. 13 depicts the handle and cap of the sample collector. [Figure 2e] FIG. 1 illustrates a collection end and plug of a sample collector having a supply orifice and a delivery orifice. [Figure 2f] FIG. 13 depicts a sample collector plug without the collection end attached. [Figure 3a] FIG. 1 is a diagram illustrating a collection tube of a biological sample collection system. [Figure 3b] FIG. 13 depicts a delivery system in which the sample collector includes a plug without a collection end attached. [Figure 3c] FIG. 1 depicts a delivery system in which the sample collector includes a plug and a collection end having a swab. [Figure 3d] FIG. 13 depicts a delivery system in which the sample collector includes a plug without a collection end attached and a cap. [Figure 3e] FIG. 1 depicts a delivery system in which the sample collector includes a plug, a collection end having a swab, and a cap. [Figure 4] FIG. 1 is a diagrammatic representation of a method for assembling a sample collector. [Figure 5a] FIG. 1 depicts a method for collecting and processing a biological sample using a biological sample and delivery system. [Figure 5b-1] FIG. 5b is a diagrammatic representation of the method depicted in FIG. 5a. [Figure 5b-2]FIG. 5b is a diagrammatic representation of the method depicted in FIG. 5a. [Figure 5b-3] FIG. 5b is a diagrammatic representation of the method depicted in FIG. 5a. [Figure 6a] FIG. 2 is a diagram of a dispensing attachment. [Figure 6b] FIG. [Figure 6c] FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] A biological sample collection system and a delivery system are described. The biological sample collection system provides for collection and processing of a biological sample (i.e., bodily fluids collected from the nose, throat, or other mucous membranes of an animal or human). The biological sample collection system includes a sample collector and a collection tube. The sample collector provides structure for sealing the biological sample in the collection tube for further processing without opening the collection tube, and may provide structure for collecting the biological sample. When the sample collector and the collection tube are removably attached, a delivery system is formed. The delivery system provides for further processing of the biological sample without opening the collection tube (i.e., without unlocking or removing the plug from the collection tube). The delivery system further provides for delivery of the processed biological sample without opening the collection tube.

[0017] 2a depicts a sample collector 200 of a biological sample collection system 250 (shown at 503 in FIG. 5b). The sample collector 200 includes a plug 207. The sample collector 200 may further include a collection end 201, a handle 202, a cutting point 204, and a cap 208.

[0018] 2b depicts the collection end and plug of a sample collector 200 of a biological sample collection system. Collection end 201 may include a swab 203. Collection end 201 and swab 203 are those of a conventional collection swab, such as representative conventional collection swabs 101 and 103, respectively. Collection end 201 and plug 207 may both be 40-60 millimeters (mm) in length.

[0019] The plug 207 of the sample collector 200 includes an attachment mechanism 212, a ridge 211, and a delivery orifice 209. The plug 207 may include a delivery orifice 210. The plug 207 allows sealing of the biological sample collection system to form a delivery system and processing of the biological sample without opening the collection tube. The collection end 201 may be attached to the plug 207, or the collection end and plug may be formed as a single piece. The plug 207 is of a diameter to be received by the collection tube 301, such as 4-12 mm in diameter (see Figures 3a-3e). The plug is of a length to be received by the collection tube 301 and to receive the cap 208, such as 9-12 mm in diameter.

[0020] The attachment mechanism 212 and ridges 211 removably attach and seal the sample collector in the collection tube 301 (see FIGS. 3a-3e). The attachment mechanism 212 is below the ridges 211 to receive the collection tube 301 in a removable attachment. The attachment mechanism 212 can also be above the ridges 211 to receive the cap 208 in a removable attachment. The attachment mechanism 212 receives the collection tube 301 and attaches to the plug 207 to form the delivery system 300 (see FIGS. 3b-3e). The attachment mechanism 212 can be a thread (as shown in FIG. 2b), a snap cap, or a groove and lock and combinations thereof.

[0021] The ridge 211 is generally in the center of the plug 207, such as 4-5 mm from the bottom of the plug 207. The ridge 211 is circular with a diameter larger than the body of the plug 207 and has a height of 0.5-2 mm. The ridge 211 provides that the plug 207 and the collection end 201 enter the collection tube 301 only a distance until the ridge 211 contacts the collection tube 301. The ridge 211 also seals the collection tube 301, which may contain the medium and the collection end 201 with the biological sample, to form the delivery system 300.

[0022] A delivery orifice 209 extends through the plug 207 to allow delivery of a controlled amount of liquid from the collection tube 301 for further processing and analysis. For example, a processed biological sample may be delivered from the collection tube 301 for polymerase chain reaction (PCR) analysis. The delivery orifice 209 is generally open at the top of the plug 207 (as shown in Figures 2e and 2f) and extends through the plug 207 to be open at the bottom plug 207. The delivery orifice is hollowed out to allow delivery of a controlled amount of liquid per drop, and the delivery orifice may be hollowed out to allow delivery of approximately 20-40 microliters per drop.

[0023] When the plug 207 includes the delivery orifice 210, the delivery orifice 210 extends through the plug 207 to allow liquid to enter the collection tube 301 to contact the biological sample for processing. For example, buffer, reagent, or water may be delivered into the collection tube 301. The delivery orifice 210 is open at the top of the plug 207 (as shown in Figures 2e and 2f) and extends through the plug 207 to open at the bottom of the plug 207. The delivery orifice 210 is 1-2 mm in diameter.

[0024] 2c is a top down view of plug 207. This view shows ridge 211, delivery orifice 209, and collection end 201.

[0025] FIG. 2d depicts the handle 202 and cap 208 of the sample collector 200. The handle 202 is cylindrical and configured for holding by a user to move the sample collector between collection and removably attaching the plug 207 to the collection tube 301. The handle is 100-120 mm in length. The handle includes a break point 204 configured to detach the handle 202 from the cap 208, for example, after collecting a biological sample and securing the plug 207 to the collection tube 301. The break point 204 is structurally weaker than the remainder of the handle 202, such that the break occurs at the break point 204 and not elsewhere on the handle 202. The handle 202 is attached to the cap 208 at the break point 204.

[0026] The cap 208 is configured for attachment to the plug 207 to prevent liquid from entering or exiting the collection tube 301 from the delivery orifice 210 and the supply orifice 209 when in a locked position (see 506 in FIG. 5b). The cap 208 is of a complementary shape to the plug 207, such as a dome shape, to fit over the plug 207. The cap 208 includes a cap fastening mechanism 213 that is complementary to the attachment mechanism 212 on the ridge 211 to removably attach the cap 208 to the plug 207. For example, the cap fastening mechanism 213 can be a receiving thread, a snap cap, or a groove insert that corresponds to the attachment mechanism 212 of the plug 207.

[0027] The cap 208 may include a first orifice 214 that corresponds to the dispensing orifice 209. The first orifice 214 extends through the cap 208. The first orifice 214 aligns with the dispensing orifice 209 when the cap 208 is in the dispensing position (e.g., the cap 208 is twisted ¼ or ½ from the locked position to align the first orifice 214 with the dispensing orifice 209) to enable dispensing of liquid from the collection tube 301 as described with respect to FIG.

[0028] The cap 208 may include a second orifice 215 that corresponds to the delivery orifice 210. The second orifice 215 extends through the cap 208. The second orifice 215 aligns with the delivery orifice 210 when the cap 208 is in the delivery position (e.g., the cap 208 is twisted ¼ or ½ from the locked position to align the second orifice 215 with the delivery orifice 210) to enable delivery of liquid to the collection tube 301 as described with respect to FIG. When the cap 208 includes the first orifice 214 and the second orifice 215, the first and second orifices may be staggered such that when the first orifice 214 is in the dispensing position, the second orifice 215 is not in the dispensing position, such that the dispensing orifice 210 remains sealed such that liquid does not exit the dispensing orifice when dispensing liquid from the dispensing orifice 209. Similarly, when the second orifice 215 is in the dispensing position, the first orifice 214 is not in the dispensing position, such that the dispensing orifice 209 remains sealed.

[0029] FIG. 2e depicts the collection end 201 and plug 207 of the sample collector 200 of the biological sample collection system, with the supply orifice 209 and delivery orifice 210 shown in solid lines for illustrative purposes, even though those orifices extend through the interior of the plug 207.

[0030] 2f depicts the sample collector 200 without the collection end 201. The plug 207 without the collection end 201 may be removably attached to the collection tube 301 to facilitate delivery of liquid to and from the collection tube 301.

[0031] FIG. 3a depicts a collection tube 301 of a biological sample collection system. The collection tube 301 is configured to receive the plug 207 of the sample collector 200 and the collection end 201 of the sample collector 200, as well as to hold and dispense liquid. The collection tube 301 is 30-60 mm in height and has an outer diameter of 5-12 mm. The collection tube 301 includes a flexible tube 302 and a receiving portion 303. The flexible tube 302 is a material such as a flexible plastic of polycarbonate or polyethylene that holds liquid but is flexible to allow conformability by a user's finger, for example, to dispense liquid.

[0032] The receiving portion 303 includes a receiving feature 312 configured to receive the plug 207. The receiving portion 303 is a less flexible material than the flexible tube 302, such as a rigid plastic, or is a thicker section of material of the flexible tube 302. The receiving feature 312 is complementary to the attachment feature 212 of the plug 207 below the ridge 211 to removably attach the plug 207 to the collection tube 301. For example, the receiving feature 312 can be a receiving thread, a snap cap, or a groove insert that corresponds to the plug 207.

[0033] FIG. 3b depicts a delivery system 300 in which the sample collector 200 includes a plug without a collection end attached and a collection tube 301, with the plug 207 removably attached to the collection tube 301 via a receiving feature 312 and an attachment feature 212 to form the delivery system 300.

[0034] FIG. 3c depicts a delivery system 300 in which the sample collector 200 includes a plug 207 and a collection end 201 having a swab 203, the plug 207 being removably attached to the collection tube 301 via a receiving mechanism 312 and an attachment mechanism 212 to form the delivery system 300.

[0035] 3d depicts a delivery system 300 in which the sample collector 200 includes a plug 207 without a collection end attached, and a cap 208, where the plug 207 is removably attached to the collection tube 301 via a receiving feature 312 and an attachment feature 212 to form the delivery system 300. The cap 208 is removably secured to the plug via a cap securing feature 213 and an attachment feature 212.

[0036] 3e depicts a delivery system 300 in which the sample collector 200 includes a plug 207, a collection end 201 having a swab 203, and a cap 208, with the plug 207 removably attached to the collection tube 301 via a receiving feature 312 and an attachment feature 212 to form the delivery system 300. The cap 208 is removably attached to the plug via a cap securing feature 213 and an attachment feature 212.

[0037] 6a, 6b, and 6c each depict a feeding system having a feeding fitting 601. The feeding fitting 601 is configured for additional precision in feeding the biological sample from the collection tube 301 through the feeding orifice 209 (i.e., the location where the biological sample will be fed), such as feeding into a smaller tube, a second collection tube, or feeding into multiple tubes simultaneously. The feeding fitting 601 includes a feeding fitting securing mechanism 613 that is complementary to the mounting mechanism 212 for securing the feeding fitting 601 to the plug 207. For example, the feeding fitting securing mechanism 613 can be a receiving thread, a snap cap, or a groove insert that corresponds to the plug 207. The feeding fitting securing mechanism 613 removably attaches the feeding fitting 601 to the plug 207.

[0038] FIG. 6a depicts a supply fitting 601 removably secured to plug 207, the supply fitting 601 including a tapered tube (e.g., a pipette tube) to enable accurate delivery of a biological sample into a smaller tube, such as a standard PCR tube.

[0039] FIG. 6b depicts a supply fitting 601 secured to the plug 207, which is a collection tube, to allow accurate delivery of the biological sample to the collection tube.

[0040] FIG. 6c depicts a supply fitting 601 secured to plug 207, the supply fitting 601 including multiple channels to enable precise simultaneous delivery of biological samples to multiple receptacles, such as multiple well plates.

[0041] 4 is a diagrammatic representation of a method of assembling a sample collector 200. Once the handle 202 and cap 208 are formed as a single piece, and the plug 207 and collection end 201 are formed as a single piece, they may be assembled as shown at 401, where the attachment feature 212 on the ridge 211 is removably attached to the cap receiving feature 213. Once secured, at 402, the sample collector 200 is formed. The sample collector 200 may be sterilized prior to packaging at 403. At 403, the sample collector is packaged in a sealed container, such as a paper or plastic container.

[0042] Figure 5a is a method 500 for collecting and processing a biological sample using a biological sample and delivery system, and Figure 5b is a corresponding diagrammatic representation of method 500. At 501 in Figures 5a and 5b, the sample collector 200 is removed from a sealed packaging, such as that described at 403, and the sealed packaging is opened from the handle end of the sample collector 200 such that the handle 202 is grasped by a user.

[0043] At 502 in Figures 5a and 5b, a biological sample is collected according to a collection protocol for the particular biological sample. For example, when the biological sample is a nasal specimen, the swab 203 of the sample collector 200 is inserted into the nose, rotated 3-4 complete rotations, and removed from the nostril with the biological sample on the swab 203 of the sample collector.

[0044] At 503 in Figures 5a and 5b, the swab 203 with the biological sample is inserted into a collection tube 301. The collection tube 301 may contain a medium 307 if the protocol for processing the biological specimen specifies a medium. For example, when the biological sample is a nasal specimen, the medium 307 may include a standard viral transport media (VTM) or a universal transport media (UTM) and a buffer configured for use with the biological sample. After the biological sample contacts the medium, the biological sample is in solution with the medium 307, and this solution is referred to as the biological sample.

[0045] At 504 in Figures 5a and 5b, the plug 207 of the sample collector 200 is removably attached to the collection tube 301 via the fixing mechanism 312 and the attachment mechanism 212, and the collection end 201 extends into the collection tube 301 up to the ridge 211 where the plug 207 is fully removably attached to the collection tube 301.

[0046] At 505 in Figures 5a and 5b, the handle is detached from the sample collector 200 via the break point 204 to form a delivery system. For example, a user may break the handle at the break point 204 and discard the handle 202. Removing the handle forms the delivery system depicted at 506 in Figure 5b, where the delivery system is shown. The delivery system shown at 506 includes a cap 208 that is fully removably secured to the plug 207 via the cap securing mechanism 213 and the attachment mechanism 212 on the ridge. The fully removably secured plug 207 and cap 208 are in a locked position, such that the medium contacted with the biological specimen will be contained within the collection tube and will not leak or exit the collection tube 301 when inverted.

[0047] At 507 in FIGS. 5 a and 5 b , the cap 208 is unsecured (ie removed) from the plug 207 to place the dispensing system in a dispensing position where liquid can be dispensed through the dispensing orifice 209 .

[0048] At 508, the biological sample is delivered through the delivery orifice 209. The biological sample delivered through the delivery orifice 209 is volume controlled such that each drop is a consistent approximation of the sample, such as 20-40 microliters per drop. The biological sample may be delivered into a second collection tube 301 configured to receive a sample collector that includes a plug 207 and does not include a collection end 201, for further processing and delivery.

Claims

1. 1. A sample collector for collecting a biological sample, the sample collector comprising: A plug for sealing a collection tube, said plug comprising: an attachment mechanism for removably attaching the plug to the collection tube, the attachment mechanism being below a ridge; the ridge having a diameter greater than the body of the plug and generally in the center of the plug; a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out; A plug comprising: a collection end, the collection end attached to a bottom of the plug, the collection end including a swab for biological sample collection; a handle, the handle attached to the top of the plug, the handle including a cut point for removing the handle; A sample collector comprising:

2. a cap configured to seal the collection tube by releasable attachment to the plug via a cap fastening mechanism; a cap, the attachment mechanism of the plug being on top of the ridge, the cap fastening mechanism being complementary to the attachment mechanism, and the handle being attached to the top of the cap; The sample collector of claim 1 , further comprising:

3. the cap further comprising a first orifice for dispensing liquid when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; The sample collector of claim 2 .

4. the plug further comprises a delivery orifice for delivering liquid to the collection tube, the delivery orifice extending through the plug adjacent the supply orifice; The sample collector of claim 2 .

5. the cap further comprising a second orifice for dispensing liquid when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; the second orifice is offset from the first orifice such that when the cap is in the dispensing position, the first orifice is not aligned with the delivery orifice and is not in the delivery position; The sample collector of claim 4.

6. a collection tube configured to receive the collection end and the plug, the sample collection tube comprising: a flexible tube configured to hold a liquid, said flexible tube being a flexible plastic material; a receiving portion that is a material less flexible than the flexible tube, the receiving portion configured to receive the plug via a receiving mechanism; a receiving portion, the receiving feature being complementary to the attachment feature beneath the ridge of the plug; A collection tube The sample collector of claim 1 , further comprising:

7. The collection tube has a height of 30-60 millimeters and an outer diameter of 5-12 millimeters. The sample collector of claim 6.

8. the attachment mechanism is selected from the group consisting of threads, snap receivers, or grooves and locking mechanisms, and combinations thereof; The sample collector of claim 6.

9. 1. A biological sample collection system for containing a biological sample, the biological sample collection system comprising: A plug for sealing a collection tube, said plug comprising: an attachment mechanism for removably attaching the plug to the collection tube, the attachment mechanism being below a ridge; and the ridge having a diameter greater than the body of the plug and generally in the center of the plug; a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out; A plug comprising: a handle, the handle attached to a top of the plug, the handle including a cut point for removing the handle; A collection tube configured to receive the plug, the sample collection tube comprising: a flexible tube configured to hold a liquid, the flexible tube being a flexible plastic material; a receiving portion that is a material less flexible than the flexible tube, the receiving portion configured to receive the plug via a receiving mechanism; a receiving portion, the receiving feature being complementary to the attachment feature beneath the ridge; A collection tube; A biological sample collection system comprising:

10. a cap configured to seal the collection tube by releasable attachment to the plug via a cap fastening mechanism; a cap, the attachment mechanism of the plug being on top of the ridge, the cap fastening mechanism being complementary to the attachment mechanism, and the handle being attached to the top of the cap; The system of claim 9 further comprising:

11. the cap further comprising a first orifice for dispensing liquid when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; The system of claim 10.

12. 1. A biological sample delivery system for delivering a biological sample, the biological sample delivery system comprising: A plug for sealing a collection tube, said plug comprising: an attachment mechanism for removably attaching the plug to the collection tube, the attachment mechanism being below a ridge; the ridge having a diameter greater than the body of the plug and generally in the center of the plug; a delivery orifice for delivering a controlled amount of liquid from the collection tube, the delivery orifice extending through the plug and hollowed out; A plug comprising: a collection end, the collection end attached to a bottom of the plug, the collection end including a swab for biological sample collection; a collection tube removably attached to the plug, the sample collection tube comprising: a flexible tube configured to hold a liquid, said flexible tube being a flexible plastic material; a receiving portion that is a material less flexible than the flexible tube, the receiving portion configured to receive the plug via a receiving mechanism; a receiving portion, the receiving feature being complementary to the attachment feature beneath the ridge of the plug; A collection tube; A biological sample supply system comprising:

13. a cap, the cap sealing the collection tube, the cap being removably attached to the plug via a cap fastening mechanism; The attachment mechanism of the plug is further on the ridge, and the cap fastening mechanism is complementary to the attachment mechanism. The system of claim 12 further comprising:

14. the cap further comprising a first orifice for dispensing liquid when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; The system of claim 13.

15. the plug further comprises a delivery orifice for delivering liquid to the collection tube, the delivery orifice extending through the plug adjacent the supply orifice; The system of claim 13.

16. the cap further comprising a second orifice for dispensing liquid when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; the second orifice is offset from the first orifice such that when the cap is in the dispensing position, the first orifice is not aligned with the delivery orifice and is not in the delivery position; The system of claim 15.

17. a delivery fitting configured to precisely dispense liquid from the collection tube, the delivery fitting removably attached to the plug via a delivery fitting fastening mechanism; the attachment mechanism of the plug is further on the ridge, and the supply fitting fastening mechanism is complementary to the attachment mechanism. The system of claim 12 further comprising:

18. 1. A method for collecting and processing a biological sample in a biological sample collection and delivery system, the method comprising: Collecting a biological sample using a sample collector, the sample collector comprising: A plug for sealing a collection tube, said plug comprising: an attachment mechanism configured to removably attach the plug to the collection tube, the attachment mechanism underlying a ridge; the ridge having a diameter greater than the body of the plug and generally in the center of the plug; a delivery orifice for delivering a controlled amount of liquid from said collection tube, said delivery orifice extending through said plug and hollowed out to deliver said controlled amount of liquid of 20-40 milliliters per drop; A plug comprising: a collection end, the collection end attached to a bottom of the plug, the collection end including a swab for biological sample collection; a handle, the handle attached to the top of the cap, the handle including a cut point for removing the handle; a cap configured to seal the collection tube by releasable attachment to the plug via a cap fastening mechanism; a cap, the attachment mechanism of the plug further comprising: a cap on the ridge, the cap fastening mechanism being complementary to the attachment mechanism, the cap including a first orifice for dispensing the biological sample when aligned with the dispensing orifice when the cap is in a dispensing position on the plug; collecting a biological sample; Inserting the biological sample into the collection tube; Removably attaching the sample collector to the collection tube, the collection tube comprising: a flexible tube configured to hold a liquid, said flexible tube being a flexible plastic material; a receiving portion that is a material less flexible than the flexible tube, the receiving portion configured to receive the plug via a receiving mechanism; a receiving portion, the receiving feature being complementary to the attachment feature beneath the ridge; removably attaching the sample collector to the collection tube; removing the handle from the sample collector to form the biological sample delivery system; dispensing the biological sample through the dispensing orifice when the cap is in a dispensing position; A method comprising:

19. The collecting comprises a medium for contacting the biological sample.

20. The method of claim 18.

20. 20. The method of claim 18, wherein the swab of the collecting end is selected from the group consisting of nylon, cotton, paper, and synthetic fibers.

Citation Information

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