US-12616392-B2 - Devices, methods and kits for biological sample capture and processing

Abstract

Breath liquid particles and vapor are captured in a device presenting a surface and chamber space that condenses or freezes the vapor and aerosol particulates. One or more breaths are exhaled through the device. Capture can be performed on the freezing surface immobilizing water upon contact. The chamber space within the device may freeze liquid breath particles and vapor to collect them. After collection, the liquid is gathered and collected either by draining, pushing, or centrifugal force into a vial. The liquid may be collected and combined with a sample preparation reagent such as a virus lysing reagent, an internal standard, etc. After collection, the sample is analyzed. Analysis may be performed by PCR, qPCR RT-PCR, RT-qPCR, LAMP or any nucleic acid detection method, mass spectrometry, spectrophotometry or any analytical tool or method. Nucleic acid amplification reagents may contain a lysing reagent such as acetonitrile.

Inventors

• Douglas T. Gjerde
• Daniel Robert Bollinger

Assignees

• VOSBIO, INC.

Dates

Publication Date

20260505

Application Date

20220916

Claims (20)

1. 1 . A method for detecting a target in a biological sample obtained from an exhaled breath of a user, wherein the method uses a device for collecting the biological sample from the exhaled breath which comprises a tube adapted to allow the user to breathe into the device, a collection chamber in fluid communication with the tube, the collection chamber having a capture surface, a cooling element capable of cooling the capture surface to a temperature below the freezing point of water and a turbulence inducer comprising formations disposed within or around an outer surface of the tube to cause the flow of the exhaled breath to become turbulent to enhance contact between the capture surface and the exhaled breath, wherein the method comprises breathing into the tube to provide the biological sample when the exhaled breath condenses or freezes on the capture surface of the collection chamber; and analyzing a volume of the biological sample to detect the presence of the target.
2. 2 . The method of claim 1 , wherein the tube has a first end for the user to exhale into the device and wherein the collection chamber is a vial having an interior capture surface, the vial being disposed over a second end of the tube, wherein the flow of the exhaled breath reverses around interior walls of the vial so that the biological sample condenses or freezes on the capture surface.
3. 3 . The method of claim 1 , wherein the biological sample is a frozen sample, a combination of liquid and frozen sample, or liquid sample.
4. 4 . The method of claim 1 , wherein the collection chamber has a volume between 0.5 and 50 μL.
5. 5 . The method of claim 1 , wherein the tube is used in a vertical configuration.
6. 6 . The method of claim 1 , wherein the tube is used in a horizontal configuration to enable capture of the exhaled breath without the capture of saliva or dribble.
7. 7 . The method of claim 1 , wherein the tube is used in a configuration between horizontal and vertical.
8. 8 . The method of claim 1 , wherein the turbulence inducer is an insert disposed around the tube.
9. 9 . The method of claim 8 , wherein the collection chamber is a syringe barrel, the tube fits into the barrel of the syringe, and the turbulence inducer fits around the outer surface of the tube.
10. 10 . The method of claim 1 , wherein the turbulence inducer comprises formations disposed within the outer surface of the tube sufficient to induce turbulent flow of the exhaled breath passing over them.
11. 11 . The method of claim 1 , wherein the tube is open at a first end to allow the user to breathe into the device and comprises an end wall towards a second end to deflect the exhaled breath over the capture surface to enhance contact between the capture surface and the exhaled breath.
12. 12 . The method of claim 1 , wherein the collection chamber, the tube, or both the collection chamber and the tube is removable.
13. 13 . The method of claim 1 , wherein the method has a sampling time during which the user breathes into the device of 5 min, 4 min, 3 min, 2 min, 1 min, 45 seconds, 30 seconds, 25 seconds, 20 seconds, 15 seconds, 10 seconds, or less.
14. 14 . The method of claim 1 , wherein the biological sample is captured in 6 exhaled breaths or fewer.
15. 15 . The method of claim 1 , wherein the biological sample is a liquid sample, a particulate sample, or a vapor sample in the exhaled breath.
16. 16 . The method of claim 1 , wherein the collection chamber is a removable vial.
17. 17 . The method of claim 1 , wherein the cooling element uses thermoelectric cooling to cool the capture surface.
18. 18 . The method of claim 1 , wherein the cooling element is a Peltier device.
19. 19 . The method of claim 1 , wherein the capture surface is cooled to −10° C. or colder.
20. 20 . The method of claim 1 , wherein the capture surface has a surface area of less than 50 cm 2 .

Description

FIELD OF THE INVENTION The present invention relates to devices, methods and kits for capturing and processing biological samples from breath, in particular for capturing biological samples that are liquid, particulate or vapor. BACKGROUND OF THE INVENTION Sample collection for the detection of virus and other markers is sometimes difficult, especially for children. A breath sample is less intrusive and a desirable way to sample for virus. In principle if someone is shedding and exhaling virus, the person is infectious and may spread the viral disease. However, liquid from breath is not easy to collect. Current breath liquid collection is an arduous process taking time and effort of an individual breathing into an apparatus. In addition, breath generally contains a lower viral load than a saliva or nostril swab sample. In current technology, there are limitations in capturing exhaled breath quickly and efficiently. For purposes of widespread, rapid testing for infectiousness, breath needs to be collected rapidly from large numbers of people. Many conventional systems recommend 5-10 minutes of breath to be collected prior to analysis, typically yielding a sample of 1 mL of liquid. Conventional systems may also require a cooling sleeve to be cooled in a freezer several times to provide cooling, making those systems impractical for large-scale use. Other devices for breath collection utilize similar or longer timelines, requiring at least 10 minutes each. Many such devices can collect only 1-2.4 μL/s liquid from breath, which is too small a sample for many purposes, where larger liquid volumes, e.g., 1 mL or more, need to be collected in order to remove and recover usable liquid biological sample for processing. U.S. Pat. No. 7,118,537 describes a device for condensing samples of fluid from breath in which a sleeve surrounding a collection tube may be chilled, e.g., in a home refrigerator, to improve efficiency of collection. Accordingly, there exists a need to capture the liquid particles and vapor quickly as 1 min or less from a breath sample for viral, bacterial, biological and chemical analysis. There further exists a need to quickly capture a large part (or all) of the liquid that is present in the breath sample is captured and available to be processed for detection. SUMMARY OF THE INVENTION Broadly, the present invention provides methods, devices and kits for collecting a biological sample, e.g., in the form of liquid particles, aerosol particles and/or vapor by capturing them in a device comprising a surface and chamber space that condenses or freezes the biological sample when a user exhales one or more breaths through the device. Capture can be performed on the freezing surface immobilizing water upon contact. The chamber space within the device may freeze liquid breath particles and vapor to collect them. The collected sample may be a frozen sample, a combination of liquid and frozen sample or liquid sample, for example depending on the temperature of a capture surface and the time between collection and processing. After collection, the liquid biological sample is gathered and collected for example, by draining, pushing, scraping or centrifugal force into a vial. The liquid may be collected and combined with a sample preparation reagent such as a virus lysing reagent, an internal standard, etc. After collection, the sample is analyzed. Analysis may be performed by PCR, qPCR RT-PCR, RT-qPCR, digital PCR, LAMP or any nucleic acid detection method, mass spectrometry, spectrophotometry or any analytical tool or method. Nucleic acid amplification reagents or associated reagents may contain a lysing reagent such as acetonitrile. In a first aspect, the present invention provides a method for detecting a target in a biological sample obtained from breath of a user, wherein the method uses a device for collecting a biological sample from breath which comprises a tube adapted to allow the user to breathe into the device, a collection chamber in fluid communication with the tube, the collection chamber having a capture surface, wherein collection chamber is a closed end tube or ends in a vial, a cooling element capable of cooling the capture surface to a temperature below the freezing point of water and a turbulence inducer disposed in or around the tube to cause the flow of breath to become turbulent to enhance contact between the capture surface and the exhaled breath of the user, wherein the method comprises breathing into the tube to provide a biological sample when the breath of the user condenses or freezes on the capture surface of the collection chamber;optionally allowing a frozen biological sample to melt to form a liquid biological sample for analysis;optionally processing the frozen or liquid biological sample; andanalyzing a volume of the biological sample to detect the presence of the target. In a further aspect, the present invention provides a method for detecting a target in a biological samp