SAMPLE COLLECTION DEVICES, KITS AND METHODS OF USE

• US 20150024400A1
• Filed: 02/22/2013
• Published: 01/22/2015
• Est. Priority Date: 02/22/2012
• Status: Active Grant

• Current Assignee: Life Technologies Corporation (Thermo Fisher Scientific Incorporated)
• Original Assignee: Life Technologies Corporation (Thermo Fisher Scientific Incorporated)
• Inventors: Liu, Jason Yingjie
• Granted Patent: US 9,719,130 B2
• Time in Patent Office: Days
• US Class Current: 435/6.12
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: G01N 1/30 Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis

Abstract

Devices, methods, and kits are disclosed for collection, labeling and analysis of samples containing a substance of interest. Such devices and methods are used in forensic, human identification, access and importation control, and other investigative technologies to collect even limited amounts of a substance of interest that may be present on a substrate and to facilitate analysis to identify the substance of interest.

Claims

1. A sample collection device comprising:

an active collection component comprising a first surface area configured to be an active collection surface area;

a handling component;

wherein the active collection component is detachably connected to at least one of a first or a second portion of the handling component; and

wherein the device is configured to;

a) collect a sample from at least a first surface area of a substrate to the active collection surface area; and

b) permit analysis of the sample concentrated on at least a first portion of the active collection surface area.

2. The sample collection device of claim 1, wherein the active collection component comprises material configured to be compatible with reaction conditions of the analysis.

3. The sample collection device of any one of the preceding claims, wherein the active collection surface area is configured to be the surface area encompassing an exterior edge of an angled fold of the active collection component, wherein the angled fold is formed over the first portion of the handling component.

4. The sample collection device of claim 3, wherein the at least first portion of the active collection surface area is one or more punches taken from the surface area encompassing the angled fold.

5. The sample collection device of any one of the preceding claims, wherein the active collection surface area is configured to provide at least a second portion of the active collection surface area for archiving.

6. The sample collection device of any one of the preceding claims, wherein the active collection component is configured in a sheet form.

7. The sample collection device of any one of the preceding claims, wherein the active collection component comprises fibrous material.

8. The sample collection device of claim 7, wherein the fibrous material comprises natural fibers, synthetic polymeric fibers or a combination thereof.

9. The sample collection device of any one of claims 7-8, wherein the fibrous material is Nylon®

fibers, cotton, Dacron, or paper, and optionally, wherein the fibrous material is chemically treated.

10. The sample collection device of any one of the preceding claims, wherein the first portion of the handling component further comprises a layer of absorbent material underlying the active collection component.

11. The sample collection device of any one of the preceding claims wherein the first portion of the handling component comprises a stiffening support for the active collection component.

12. The sample collection device of any one of claims 3-10, wherein a length of the active collection component along the angled fold is about 20 mm or less.

13. The sample collection device of any one of claims 3-12, wherein the exterior edge of the angled fold forms an acute angle.

14. The sample collection device of any one of the preceding claims, wherein the active collection surface area is at least about 50% smaller than the at least first surface area of the substrate.

15. The sample collection device of any one of the preceding claims, wherein the collecting of the sample to the at least first portion of the active collection surface thereby concentrates the sample from the substrate.

16. The sample collection device of any one of claims 4-10, wherein the at least first portion of the active collection surface area is configured to fit within a reaction volume of about 2 ul to about 100 ul.

17. The sample collection device of any one of the preceding claims, wherein the active collection component, the handling component, or both comprise an identifier to associate the sample with the substrate from which the sample was collected, wherein the identifier is alphanumeric, graphical, magnetic, or electromagnetic.

19. A kit comprising a sample collection device of any one of claims 1-17, and optionally, instructions for its use.

20. The kit of claim 19, wherein the kit further comprises reagents for stabilizing the sample on the active collection component for archiving or shipping.

21. The kit of any one of claims 19-20, wherein the kit comprises at least one enclosure to protect the active collection component from contamination while archiving or shipping.

22. The kit of any one of claims 19-21, wherein any combination of the active collection component, the handling component or the at least one enclosure, comprises an identifier to associate the sample with the substrate from which the sample was collected, wherein the identifier is alphanumeric, graphical, magnetic, or electromagnetic.

23. A method for collection of a sample, comprising:

a. providing a sample collection device of any one of claims 1-17;

b. providing a substrate comprising a sample; and

c. collecting the sample by contacting an active collection surface area of an active collection component of the sample collection device to at least a first surface area of the substrate.

24. The method of claim 23, further comprising the step of detaching the active collection component from at least one of a first or a second portion of the handling component of the sample collection device.

25. The method of any one of claims 23-24, further comprising the step of providing an identifier to associate the sample collected to the active collection surface area with the substrate from which the sample was collected, wherein the identifier is alphanumeric, graphical, magnetic, or electromagnetic.

26. The method of any one of claims 23-25, further comprising the step of shipping the active collection component to another location for archiving or testing.

27. The method of any one of claims 23-26, further comprising the step of separating at least a first portion of the active collection surface area from the active collection component.

28. A method of identification of a substance of interest in a sample on a substrate, comprising the steps of:

a. performing the method of any one of claims 23-27; and

b. subjecting the sample to an analysis to identify the substance of interest.

29. The method of claim 28, further comprising the step of sending the identification of the substance of interest to at least one of a law enforcement agency, immigration control agency, forensics investigative agency, food safety agency, public health agency, or financial services agency.

18. A handling component configured to support an active collection component for collection of a sample, comprising a support portion and a handle portion, wherein the support portion tapers to a thin edge.