WO2025160159A1 - Device for collecting samples - Google Patents

Abstract

A device for collecting a sample includes a tube having an open end and a second end having dropper tip for dispensing the sample; and a filter or analyte manipulation device in the tube adjacent to the dropper tip. Various components may be attached to the tube to facilitate collecting and dispensing a sample, include a funnel, a plunger and a separate dropper tip. The device may be used with a swab or a fluid solution.

Description

DEVICE FOR COLLECTING SAMPLES

RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/624,186, titled “Device for Collecting Samples,” filed January 23, 2024, which is incorporated herein by reference in its entirety.

BACKGROUND

[0001] Collecting biological samples for subsequent analysis may be a first step for a wide variety of testing situations. The skill level of the person collecting the sample may also vary, and include both health care professionals and users, for example. It may be done in point-of-care facilities, a home, a workplace, or even a car, to give just a few examples. In addition, biological samples may be collected in many ways, some of which are in fluid form such as saliva, an oral rinse or urine, and some which are combined with a fluid before analysis, such as a nasal swab or feces.

[0002] In addition to a target analyte of interest, biological samples may include impurities like mucins and other debris. Removing mucins in nasal samples, saliva samples, oral rinse samples, and likely also feces, is important for rapid or lab-based analyte detection (e.g. antigens, antibodies, small molecules, nucleic acids). For example, mucins are a PCR (polymerase chain reaction) inhibitor and can increase viscosity in nasal or saliva samples to a degree that impedes sample flow through a lateral flow test (LFT) or lab-on-a-ship microfluidic device. This can cause both false negative results with respect to the target analyte, and failed tests, where not enough material passes through the testing device to allow the control line or spot to undergo a visual change.

SUMMARY

[0003] In a first aspect, a device for collecting a sample includes a tube having an open end and a second end having dropper tip for dispensing the sample and a filter or analyte manipulation device in the tube adjacent to the dropper tip.

[0004] In another aspect, a device for collecting samples includes a tube having a nopen end with an integral funnel and a second end, a mechanical RNA/DNA shearing device in the tube adjacent to the second end, a debris filter in the tube, and a plunger sized to fit inside the tube. [0005] In yet another aspect, a device for collecting samples includes a tube having a threaded open end and a second end having a dropper tip, a filter in the tube adjacent to the dropper tip, and at least one of a threaded funnel removably attached to the threaded open end; and/or a threaded cap comprising a plunger sized to fit inside the tube removably attached to the threaded open end.

[0006] In a further aspect, a sample collection system for use with point-of-care, home or workplace test kits for detecting respiratory pathogens or other biological or chemical analytes includes a collection tube having a threaded open end, a funnel having threads for cooperatively engaging with threads of the open end of the collection tube for receiving a liquid solution after gargling by a user, wherein the funnel further comprises an air gap in the threads that allows air to escape while the liquid solution drains from the funnel into the collection tube, and a filter built into the funnel that filters debris from the gargled liquid solution.

[0007] In yet a further aspect, a method of collecting a sample using any of the devices disclosed herein may include depositing a sample into the tube, and dispensing the sample through a dropper tip incorporated within or attached to the tube.

BRIEF DESCRIPTION OF THE FIGURES

[0008] FIGS 1 A - IE are side schematic views of a device for collecting samples, in embodiments.

[0009] FIGS. 2 A - 2F show side schematic views of another device for collecting samples, in embodiments.

[0010] FIGS. 3A and 3B show side schematic views of a device for collecting samples, in embodiments.

[0011] FIGS. 4A and 4B show side schematic views of a flexible device for collecting samples, in embodiments.

[0012] FIGS. 5A and 5B show side schematic views of a device for collecting samples that uses a plunger, in embodiments.

[0013] FIG. 6 is a flowchart of a method of using any one of the devices of FIGS 1 A - IE, in embodiments.

DETAILED DESCRIPTION

[0014] Embodiments are discussed herein in terms of biological samples, but any of the disclosed embodiments may be used for the collection of any substance containing a target analyte of interest, both fluid and solid, biological or nonbiological. The biological sample may be collected as a fluid, such as saliva or an oral rinse. A solid sample or one collected using a swab may be combined with a buffer or fluid that has been pre-loaded in a tube. Once collected, samples may be tested for a target analyte in any manner. In particular, they may be added to a sample well of a rapid diagnostic test (RDT) such as a lateral flow test, a vertical flow test or a lab-on-a chip microfluidic device. Any of the devices disclosed herein may be part of a sample collection system for use with point-of-care, home or workplace test kits including a lateral flow test cartridge for detecting respiratory pathogens or other biological or chemical analytes.

[0015] FIGS 1 A - IE are side schematic views of a device 100 for collecting and dispensing samples. FIGS. 1 A - IE are best viewed together in the following description.

[0016] Device 100 includes a tube 102 and one or more components that may be attached to and removed from tube 102 during different steps of collecting and dispensing a sample. Tube 102 has a first end 104 and a second end having a dropper tip 106. First end 104 is open and may include external threads. Dropper tip 106 may be closed with a cap (not shown) or with a removable seal. In embodiments, filter 114 is positioned adjacent to dropper tip 106. Filter 114 may be a mechanical RNA/DNA shearing device, for example. In embodiments, filter 114 may be a Sepharose gel filtration column that will bind mucins or a filter containing anti-mucin antibodies. Filter 114 may also be a frit or polyethersulfone (PES) filter. In embodiments, more than one filter 114 may be used in device 100, depending on the sample and target analyte being collected.

[0017] Tube 102 may be filled with a buffer or fluid 109 for receiving a sample collected on a swab. For example, tube 102 may be filled with a lysis buffer for liberating target analytes, for example by degrading viral capsids, which encapsidate viral RNA or DNA. In this embodiment, filter 114 may be a matrix filled with anti-proteinase K antibodies that bind proteinase K protein after it liberates antigens from virions, preventing this protein (which will also break down protein analytes) from being deposited into a sample well of a rapid diagnostic test (RTD).

[0018] Tube 102 may be used to receive an oral rinse or gargle by attaching a funnel 108 to first end 104 of tube 102. In embodiments, funnel 108 is internally threaded and engages with external threads on first end 104 of tube 102 as shown in FIGS. 1A and IB. A thread block may be included to prevent the external threads of first end 104 and the internal threads on funnel 108 from fulling engaging, thus providing a ventilation gap to assist with draining fluid from funnel 108 into tube 102. Funnel 108 may include a debris filter 105 for preventing large particles from entering tube 102. Filter 105 may be a mesh screen or any of the filters discussed herein.

[0019] Device 100 may be used with cap 110 that includes plunger 112, as shown in FIG. 1C. Cap 110 is internally threaded similarly to funnel 108 so that it may engage with the external threads on first end 104 of tube 102 after funnel 108 is removed, as shown in FIGS. 1C and ID. After cap 110 is secured to tube 102, plunger 112 may be depressed to force fluid through filter 114 and out of dropper tip 106 into a sample well of an RDT or any device that may be used to analyze the collected sample for a target analyte, as shown in FIG. IE.

[0020] In embodiments, tube 102 may be made of a flexible material that may be squeezed using pressure against the sides of the tube. In this embodiment, cap 110 does not include plunger 112 and instead forms an airtight seal when attached to tube 102. This allows a compression of tube 102 to force fluid through one or more filters 1 14 and dispense the fluid from dropper tip 106.

[0021] In embodiments, dropper tip 106 may be integrally formed with tube 102, or it may be a separate cap attached to an end of tube 102.

[0022] FIGS. 2A - 2F are schematic side views of a device 200 for collecting samples. FIGS. 2A - 2F are best viewed together in the following description. Similarly to device 100, device 200 includes a tube 202 and one or more components that may be attached to or removed from tube 202 during different steps of collecting and dispensing a sample. Tube 202 has a first end 204 that is open and may include external threads, and a second end that incorporates a plunger 212. Plunger 212 may be inserted directly into tube 202 or may be part of a separate cap similar to cap 110 of device 100. A variety of manufacturing techniques may be used to secure plunger 212 in the end of tube 202.

[0023] Tube 202 may be used to receive an oral rinse or gargle sample by attaching a funnel 208 to first end 204 of tube 202. In embodiments, funnel 208 is internally threaded and engages with the external threads on first end 204 of tube 202 as shown in FIGS. 2 A and 2B. A thread block 207 may be included to prevent the external threads of first end 204 and the internal threads on funnel 208 from fully engaging, thus providing a ventilation gap to assist with draining fluid from funnel 208 into tube 202. Funnel 208 may include a debris filter 205 for preventing large particles from entering tube 202. Filter 205 may be a mesh screen or any of the filters discussed herein.

[0024] After tube 202 is filled with a fluid 209 containing a target analyte, funnel 208 may be removed so that cap 210 may be attached. Cap 210 includes a dropper tip 206 and one or more filters 214 adjacent to dropper tip. Filter 214 is an example of filter 114 and may be a mechanical RNA/DNA shearing device or a Sepharose gel filtration column that binds mucins or a filter containing anti-mucin antibodies, for example. Cap 210 may be internally threaded so that it may engage with the external threads on first end 104 of tube 202, as shown in FIGS. 2C - 2F. After cap 210 is secured to tube 202, device 200 may be angled or inverted as shown in FIG. 2E so that plunger 212 may be depressed to force fluid through filter 214 and out of dropper tip 206 into a sample well of an RDT or any device that may be used to analyze the collected sample for a target analyte as shown in FIG. 2F.

[0025] As described above for FIGS. 1 A - 1 E, tube 202 may be filled with a buffer or fluid 209 for receiving a sample collected on a swab for dissolving the sample. In embodiments, tube 102 may be filled with a lysis buffer for liberating target analytes, like viral capsids. In this embodiment, filter 214 in cap 210 may be a matrix filled with antiproteinase K antibodies that bind proteinase K protein after it liberates analytes like RNA from virions, preventing this protein (which will also break down protein analytes) from being deposited into a sample well of a rapid diagnostic test (RTD).

[0026] FIGS. 3A and 3B are side schematic views of a device 300 for collecting samples, in embodiments. FIGS. 3A and 3B are best viewed together in the following description. Similarly to device 100, device 300 includes tube 302 with a first end 304 and a second end, First end 304 is externally threaded and the second end is closed. The second end may be curved as shown or have a more flattened shape. Tube 302 is made of a flexible material so that the sides of the tube may be pressed and deformed towards each other to reduce the internal volume of tube 302. An internally threaded funnel 308 with a debris filter 305 may be attached to tube 302 so that a sample fluid such as saliva or an oral rinse may be deposited in tube 302. Filter 305 is an example of filter 105 or 205. As described above, tube 302 may be filled with a buffer or fluid for receiving a sample collected on a swab instead of or in addition to using funnel 308.

[0027] Funnel 308 may be removed and replaced with cap 310 having a dropper tip 306 and a filter 314. Filter 314 may be an example of filter 114 or filter 214. Dropper tip 306 may be sealed with a small cap or adhesive seal. After cap 310 is secured to tube 302, device 300 may then be inverted so that fluid in tube 302 may be squeezed into a sample well of an RDT or other device for performing analysis of a target analyte in the sample fluid.

[0028] FIGS. 4A and 4B are side schematic views of a device 400 for collecting samples. Device 400 includes tube 402 and one or more components that may be attached to and removed from tube 402 during different steps of collecting and dispensing a sample. Tube 402 has a first end 104 and a second end having a dropper tip 406. Dropper tip 406 may be integrally formed with tube 402 and may be sealed with cap 418 or a removable seal.

Tube 402 is made of a flexible material so that the sides of the tube may be pressed and deformed towards each other to reduce the internal volume of tube 402.

[0029] First end 404 is open, however, in this embodiment, first end 404 is internally threaded. An externally threaded funnel 408 with a debris filter 407may be attached to tube 402 so that a sample fluid such as saliva or an oral rinse may be deposited in tube 402. Filter 405 is an example of filter 105, 205, or 305. As shown in FIG. 4A, the external threads of funnel 408 include a longitudinal gap 415, or break, that is aligned across all threads. The internal threads of tube 402 include a similar gap 416. When funnel 408 is attached to tube 402, gap 415 and gap 416 align to provide a path for air flow so that fluid drains from funnel 408 into tube 402 more quickly. In embodiments, both gap 415 and gap 416 are wide enough that they don’t have to be exactly aligned.

[0030] Filter 414 is positioned at the second end of tube 402 close to dropper tip 406. Filter 410 is an example of filter 114, 214 or 314. Tube 402 may be squeezed to reduce the volume of tube 402, force the sample fluid through filter 414 and out through tip 406 into a sample well of an RDT or other device for performing analysis of a target analyte in the sample fluid. In embodiments, funnel 408 may be removed from tube 402 and replaced with insert 420, which is also internally threaded with a gap 419 to provide a path for air flow with fluid in tube 402 is dispensed through dropper tip 406.

[0031] FIGS. 5A and 5B are sides schematic views of device 500 for collecting samples. Device 500 includes tube 502 and one or more components that may be used with tube 502 during different steps of collecting and dispensing a sample. Tube 502 includes a funnel 504 that may be integrally formed with tube 502. The end of tube 502 opposite funnel 504 is externally threaded for receiving internally threaded dropper cap 510 with dropper tip 506. The external threads on tube 502 may include gap 515, which is an example of gap 415. Similarly, the internal threads on dropper cap 510 may include gap 516, which is an example of gap 416. Dropper cap 510 may include a foil seal 518 that is removed before cap 510 is attached to tube 502. In embodiments, dropper tip 506 may also be integrally formed with tube 502.

[0032] Filter 514 is positioned at the open end of tube 502 that is attached to dropper cap 510. Filter 514 is an example of filter 114, 214, 314 or 414. Debris filter 505 is positioned a distance above the filter 514. Debris filter 505 is an example of filter 105, 205, 205, or 405.

[0033] After a sample fluid is deposited in tube 502, plunger 520 is inserted through funnel 504 then pushed through tube 502 to force sample fluid through filters 505 and 514, then out through dropper tip 506 into a sample well of an RDT or other device for performing analysis of a target analyte in the sample fluid. The position of filter 505 is selected so that plunger 520 may be fully inserted into tube 502. Plunger 520 is sized to fit inside the diameter of tube 502 and form a seal.

[0034] FIG. 6 is a flowchart of a method 600 of using the device 100 of FIGS 1A - IE to collect a sample. Similar methods may be used for devices 200 - 500. Method 600 includes steps 604, 608 and 610. In embodiments, method 600 also includes steps 602 and 606.

[0035] Step 602 includes attaching a funnel to a tube. In an example of step 602, funnel 108 includes a debris filter 105 and is attached to tube 102 using a threaded attachment. The threads are designed to provide an air gap that helps fluid drain from the funnel into the tube. Tube 102 includes a filter 114 at its opposite end and a dropper tip 106.

[0036] Step 604 includes depositing a sample fluid into the tube. In an example of step 604, saliva or an oral rinse is deposited in the tube. Other forms of a sample of a target analyte may be provided. For example, for a sample collected on a swab, tube 102 may be prefilled with a buffer and the swab may be swirled in the buffer to add the target analyte.

[0037] Step 606 includes removing the funnel from the tube. In an example of step 606, funnel 108 is unscrewed and removed from tube 102.

[0038] Step 608 includes attaching a cap with a plunger to the tube. In an example of step 608, a cap 110 with plunger 112 is threaded onto the open end of tube 102. Plunger 112 is initially located in a retracted position.

[0039] Step 610 includes pressing the plunger to dispense sample fluid. In an example of step 610, plunger 112 is depressed to force sample fluid past filter 114 and out of dropper tip 106.

[0040] For purposes of illustration, several embodiments of a device for collecting samples are shown, however, other embodiments that combine the disclosed components in different ways are contemplated. Any of the components may be formed in an integral or detachable way with other components, for example.

[0041] In embodiments, samples may be collected from using a swab or a saline gargle collection system. A saline gargle sample collection system may include one or more of the components disclosed herein.

[0042] Any of the tubes disclosed herein may be pre-filled with saline and sealed with an adhesive seal that is removed before use. The seal may be made of foil or another suitable material that prevents the saline from leaking. The fluid may be used by a test subject to rinse or gargle, then returned to the tube using a funnel. The tube may also be filled with water or any fluid that facilitates dilution of throat-borne pathogens.

[0043] A threaded funnel may engage with threads at the open end of any of the disclosed tubes. After gargling the solution, the funnel is used to spit it back into the collection tube. The funnel may include a block to stop it from rotating past a certain point, or a built-in air gap in the threading that allows air to escape from the tube so the fluid drains from the funnel into the tube very quickly. This feature reduces the sample collection time and therefore the total test time. It eliminates the need to tap the tube vigorously to speed up drainage with the associated risk of splashing infectious material out of the funnel. Other mechanisms for providing an air flow path out of the funnel/collection tube are also contemplated. The threads on the funnel and the tube may be internally and externally threaded, or vice versa.

[0044] A filter may be built into the funnel to remove debris before fluid enters the tube. Debris may include particles of food or other substances from a user’ s mouth or throat.

[0045] With a saline gargle system of sample collection, there is a very large amount of fluid available for testing. In addition, some respiratory pathogens that cause symptoms similar to SARS-CoV-2 may only be found in the throat, not in nasal cavities. Thus, a saline gargle sample collection system may be useful for providing samples to multiple test strips.

[0046] In any of the embodiments disclosed herein, a mechanism to physically, enzymatically, or chemically shear RNA/DNA may be provided. For example, shearing may be done by forcing the sample fluid through one or more small bore needles, including a microneedle array of the sort used for vaccine patches, where the inside diameter of each microneedle may be as little as 5 microns. A microneedle array may include small bore blunt- end needles. Mechanical shearing of RNA/DNA may alternatively be done acoustically, such as with sonication.

[0047] In embodiments, substances such as cell/virion lysis buffer ingredients, and enzymes or chemicals for shearing RNA/DAN, may be sprayed onto the bottom and side walls of any of the tubes disclosed herein, then dried in place. These ingredients may then be solubilized when a sample fluid is deposited in the tube by a user.

[0048] Changes may be made in the above methods and systems without departing from the scope hereof. It should thus be noted that the matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. Herein, and unless otherwise indicated: (a) the adjective "exemplary" means serving as an example, instance, or illustration, and (b) the phrase “in embodiments” is equivalent to the phrase “in certain embodiments,” and does not refer to all embodiments. The following claims are intended to cover all generic and specific features described herein, as well as all statements of the scope of the present method and system, which, as a matter of language, might be said to fall therebetween.

Combination of Features

[0049] Features described above as well as those claimed below may be combined in various ways without departing from the scope hereof. The following examples illustrate possible, non-limiting combinations of features and embodiments described above. It should be clear that other changes and modifications may be made to the present embodiments without departing from the spirit and scope of this invention:

[0050] Embodiment 1. A device for collecting a sample, comprising: a tube having an open end and a second end having dropper tip for dispensing the sample; and a filter or analyte manipulation device in the tube adjacent to the dropper tip.

[0051] Embodiment 2. The device of embodiment 1 , wherein the tube includes threads at the open end, further comprising: a threaded funnel cooperatively engaging with the threads at the open end of the tube.

[0052] Embodiment 3. The device of embodiment 2, wherein the threaded funnel includes an air gap that allows air to escape from the tube when a sample drains from the threaded funnel into the tube.

[0053] Embodiment 4. The device of either of embodiments 2 or 3, further comprising a debris filter in the threaded funnel that filters debris before the sample flows into the tube.

[0054] Embodiment 5. The device of any one of embodiments 1-4, wherein the filter or analyte manipulation device comprises a mechanical RNA/DNA shearing device, a Sepharose gel filtration column, or a frit filter.

[0055] Embodiment 6. The device of any one of embodiments 1-5, wherein the tube is coated with dried enzymes or chemicals.

[0056] Embodiment 7. The device of any one of embodiments 1-6, wherein the tube includes threads at the open end, further comprising:

[0057] a threaded cap having a plunger sized to fit inside the tube, the threaded cap cooperatively engaging with the threads at the open end of the tube.

[0058] Embodiment 8. The device of any one of embodiments 1-7, wherein the tube is flexible and includes threads at the open end, and the device further comprises a threaded cap cooperatively engaging with the threads at the open end of the tube, the threads comprising an air gap that allows air to escape when sides of the tube are compressed to dispense the sample from the dropper tip.

[0059] Embodiment 9. A device for collecting samples, comprising: a tube having an open end with an integral funnel and a second end; a mechanical RNA/DNA shearing device in the tube adjacent to the second end; a debris filter in the tube; and a plunger sized to fit inside the tube.

[0060] Embodiment 10. The device of embodiment 9, wherein the second end of the tube is threaded, the device further comprising a cap incorporating a dropper tip and threads for cooperatively engaging with the threaded second end of the tube.

[0061] Embodiment 11. A device for collecting samples, comprising: a tube having a threaded open end and a second end having a dropper tip; a filter in the tube adjacent to the dropper tip; and at least one of a threaded funnel removably attached to the threaded open end; and/or a threaded cap comprising a plunger sized to fit inside the tube removably attached to the threaded open end.

[0062] Embodiment 12. The device of embodiment 11, wherein the filter is a mechanical RNA/DNA shearing device.

[0063] Embodiment 13. The device of embodiment 12, wherein the mechanical RNA/DNA shearing device is one or more small bore needles with inside diameter of 5 microns to 1 mm.

[0064] Embodiment 14. A sample collection system for use with point-of-care, home or workplace test kits for detecting respiratory pathogens or other biological or chemical analytes, comprising: a collection tube having a threaded open end; a funnel having threads for cooperatively engaging with threads of the open end of the collection tube for receiving a liquid solution after gargling by a user, wherein the funnel further comprises an air gap in the threads that allows air to escape while the liquid solution drains from the funnel into the collection tube; and a filter built into the funnel that filters debris from the gargled liquid solution.

[0065] Embodiment 15. The sample collection system of embodiment 14, wherein a second end of the collection tube has a plunger, the sample collection system further comprising: a cap with dropper tip and threads for cooperatively engaging with the threaded open end of the collection tube; and a filter in the cap adjacent to the dropper tip that filters the gargled liquid solution before it is transferred to a sample well of the test kit.

[0066] Embodiment 16. The sample collection system of either of embodiments 14 or

15, wherein the tube is flexible and includes threads at the open end, and the system further comprises: a threaded cap having a dropper tip, the threaded cap cooperatively engaging with the threads at the threaded open end of the collection tube, the threads comprising an air gap that allows air to escape when sides of the collection tube are compressed to dispense the sample from the dropper tip.

[0067] Embodiment 17. The sample collection system of any of embodiments 14-16, wherein the collection tube is pre-filled with a liquid solution and sealed with a removable seal.

[0068] Embodiment 18. The sample collection system of any of embodiments 14-17, comprising:

[0069] a threaded cap with dropper for cooperatively engaging with the threads of the open end of the collection tube.

[0070] Embodiment 19. A method of collecting a sample using the device of embodiment 11, comprising: depositing a sample into the tube; attaching the threaded cap to the threaded open end of the tube; and dispensing the sample through the dropper tip using the plunger.

[0071] Embodiment 20. The method of embodiment 19, further comprising: attaching the threaded funnel to the tube before depositing the sample into the tube; and removing the threaded funnel from the tube before attaching the threaded cap.

Claims

CLAIMS What is claimed is:

1. A device for collecting a sample, comprising: a tube having an open end and a second end having dropper tip for dispensing the sample; and a filter or analyte manipulation device in the tube adjacent to the dropper tip.

2. The device of claim 1, wherein the tube includes threads at the open end, further comprising: a threaded funnel cooperatively engaging with the threads at the open end of the tube.

3. The device of claim 2, wherein the threaded funnel includes an air gap that allows air to escape from the tube when a sample drains from the threaded funnel into the tube.

4. The device of claim 2, further comprising a debris filter in the threaded funnel that filters debris before the sample flows into the tube.

5. The device of claim 1, wherein the filter or analyte manipulation device comprises a mechanical RNA/DNA shearing device, a Sepharose gel filtration column, or a frit filter.

6. The device of claim 1, wherein the tube is coated with dried enzymes or chemicals.

7. The device of claim 1, wherein the tube includes threads at the open end, further comprising: a threaded cap having a plunger sized to fit inside the tube, the threaded cap cooperatively engaging with the threads at the open end of the tube.

8. The device of claim 1 , wherein the tube is flexible and includes threads at the open end, and the device further comprises: a threaded cap cooperatively engaging with the threads at the open end of the tube, the threads comprising an air gap that allows air to escape when sides of the tube are compressed to dispense the sample from the dropper tip.

9. A device for collecting samples, comprising: a tube having an open end with an integral funnel and a second end; a mechanical RNA/DNA shearing device in the tube adjacent to the second end; a debris filter in the tube; and a plunger sized to fit inside the tube.

10. The device of claim 9, wherein the second end of the tube is threaded, the device further comprising a cap incorporating a dropper tip and threads for cooperatively engaging with the threaded second end of the tube.

11. A device for collecting samples, comprising: a tube having a threaded open end and a second end having a dropper tip; a filter in the tube adjacent to the dropper tip; and at least one of a threaded funnel removably attached to the threaded open end; and/or a threaded cap comprising a plunger sized to fit inside the tube removably attached to the threaded open end.

12. The device of claim 11, wherein the filter is a mechanical RNA/DNA shearing device.

13. The device of claim 12, wherein the mechanical RNA/DNA shearing device is one or more small bore needles with inside diameter of 5 microns to 1 mm.

14. A sample collection system for use with point-of-care, home or workplace test kits for detecting respiratory pathogens or other biological or chemical analytes, comprising: a collection tube having a threaded open end; a funnel having threads for cooperatively engaging with threads of the open end of the collection tube for receiving a liquid solution after gargling by a user, wherein the funnel further comprises an air gap in the threads that allows air to escape while the liquid solution drains from the funnel into the collection tube; and a filter built into the funnel that filters debris from the gargled liquid solution.

15. The sample collection system of claim 14, wherein a second end of the collection tube has a plunger, the sample collection system further comprising: a cap with dropper tip and threads for cooperatively engaging with the threaded open end of the collection tube; and a filter in the cap adjacent to the dropper tip that filters the gargled liquid solution before it is transferred to a sample well of the test kit.

16. The sample collection system of claim 14, wherein the tube is flexible and includes threads at the open end, and the system further comprises: a threaded cap having a dropper tip, the threaded cap cooperatively engaging with the threads at the threaded open end of the collection tube, the threads comprising an air gap that allows air to escape when sides of the collection tube are compressed to dispense the sample from the dropper tip.

17. The sample collection system of claim 14, wherein the collection tube is pre-filled with a liquid solution and sealed with a removable seal.

18. The sample collection system of claim 14, comprising: a threaded cap with dropper for cooperatively engaging with the threads of the open end of the collection tube.

19. A method of collecting a sample using the device of claim 11, comprising: depositing a sample into the tube; attaching the threaded cap to the threaded open end of the tube; and dispensing the sample through the dropper tip using the plunger.

20. The method of claim 19, further comprising: attaching the threaded funnel to the tube before depositing the sample into the tube; and removing the threaded funnel from the tube before attaching the threaded cap.