SANITARY SWAB COLLECTION SYSTEM, MICROFLUIDIC ASSAY DEVICE, AND METHODS FOR DIAGNOSTIC ASSAYS

• US 20100274155A1
• Filed: 01/28/2010
• Published: 10/28/2010
• Est. Priority Date: 07/31/2007
• Status: Active Grant

• Current Assignee: Perkinelmer Health Sciences Incorporated (Perkinelmer Incorporated)
• Original Assignee: Micronics Inc. (Sony Group Corp.)
• Inventors: Haab, Joan, Gerdes, John, Clemmens, John, Battrell, C. Frederick, Capodanno, Jason
• Granted Patent: US 8,216,832 B2
• Time in Patent Office: Days
• US Class Current: 600/572
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/082 Handling hazardous material
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0854 Double walls
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0415 electrical forces, e.g. electrokinetic
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: G01N 1/02 Devices for withdrawing samples sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising

Abstract

Biohazard specimen collection containers are provided with an external disposable skin, that is stripped away and discarded after the biohazardous specimen is collected, thus reducing or eliminating objectionable or dangerous residues on the outside surfaces of the container. Further, we teach that the sample collection container with external disposable skin may also serve as an integrated microfluidic biosample processing and analytical device, thereby providing a single entry, disposable assay unit, kit and system for “world-to-result” clinical diagnostic testing. These integrated assay devices are provided with synergic, multiple safe-handling features for protecting healthcare workers who handle them. The modified collection containers and analytical devices find application, for example, in PCR detection of infectious organisms or pathogenic markers collected on a swab.

Claims

1. A swab collection device for sanitary collection of a biohazardous sample on a swab, comprising:

a) a body (10,30,45,131,140) with external surfaces (11), at least one internal hollow volume (33,36) for receiving said swab, and a sealable closure (7,34,35,165) for separating said external surfaces (11) from said internal hollow volume (33,36,156) following collection of the swab,

b) wherein said external surfaces are further characterized as comprising at least one disposable external skin layer (2,3,50,60,71,72,81,132,133,142,144,155,159), whereby after the swab (20,32,152,158) with biohazardous sample is enclosed and sealed within the internal hollow volume, any biohazardous residues accumulated on the external surfaces of the device body during sampling are removed by removing and disposing of the disposable external skin layer immediately after the sample collection process is completed and before further processing and transport.

2. The swab collection device of claim 1, further comprising a valved (37) microfluidic channel (39) fluidly joining a first compartment (33) of said internal hollow volume for receiving said swab and a second compartment of said internal hollow volume having a microfluidic assay circuit (42), said microfluidic assay circuit for performing a fluidic operation on said sample collected on said swab.

3. The swab collection device of claim 2, further comprising at least one on-board liquid reagent (40,41) for performing the fluidic operation.

4. The swab collection device of claim 3, wherein said fluidic operation is selected from sample analysis or sample preparation.

5. The swab collection device of claim 1, wherein said disposable skin layer is composed of a plastic.

6. The swab collection device of claim 1, wherein said disposable external skin layer (2,3,) is composed of a polyethylene layer adhered to said external surface or surfaces.

7. The swab collection device of claim 1, wherein said disposable external skin layer (2,3,50,60,71,72,81,132,133,142,144,155,159) comprises a paper.

8. The swab collection device of claim 1, wherein said disposable external skin layer (2,3,50,60,71,72,81,132,133,142,144,155,159) comprises a paper/plastic composite.

9. The swab collection device of claim 1, wherein said disposable external skin layer (2,3) is a film.

10. The swab collection device of claim 1, wherein said disposable skin layer (2,3,50,60,71,72,81,132,133,142,144,155,159) further comprises an absorbent bat.

11. The swab collection device of claim 1, wherein said disposable skin layer (71,72,132,133,142,144,155,159) is a molded article.

12. The swab collection device of claim 1, wherein said disposable skin layer (71,72,132,133,142,144,155,159) is a clamshell comprising two Styrofoam blocks.

13. The swab collection device of claim 1, wherein said disposable skin layer (50,81) is composed of a heatshrinkable plastic.

14. The swab collection device of claim 1, wherein said disposable skin layer (2,3) further comprises a tab (4,5) for peeling and an underlayer of a removable pressure sensitive adhesive.

15. The swab collection device of claim 1, wherein said disposable skin layer (132,133, 155,159) further comprises a tearstrip (168) for tearing.

16. The swab collection device of claim 1, wherein said disposable skin layer (60) further comprises a circumferential sealing rib (61) for interlocking with a female seal groove (62) on said exterior surface.

17. The swab collection device of claim 1 comprising a swab receiving chamber (33,156) wherein said sealable closure (7,34,35,165) is fitted to a swab receiving orifice (134,141,153) for receiving said swab (20,32,152,158).

18. The swab collection device of claim 1, further comprising an internal reservoir containing an extraction reagent (41).

19. The swab collection device of claim 18 wherein said extraction reagent is contained in a frangible blister pack.

20. A kit comprising a tray or box provided with a swab collection device of claim 1.

21. The swab collection device of claim 1, wherein said disposable external skins comprise labeling information.

22. A method for collecting a biohazardous sample, comprising the steps of:

a) providing a swab and a microfluidic analytical device with body and with swab receiving orifice, said swab with specimen collection tip and handle, said tip and handle joined by a frangible shaft with breakpoint, said body with external surfaces and internal hollow volume, said external surfaces with disposable skin or skins, said swab receiving orifice with sealable closure;

b) using said swab to collect a biohazardous sample and inserting said specimen collection tip into said swab receiving orifice to the breakpoint on the handle;

c) breaking off the swab handle at the breakpoint and sealing the swab specimen collection tip within the body of the device by closing the sealable closure over the swab receiving orifice; and

,

d) removing said disposable skin or skins from said external surfaces immediately after the sample collected process is completed and before further processing and transport.

23. A method for collecting a biohazardous sample, comprising the steps of:

a) providing a swab and a microfluidic analytical device with body and with swab receiving orifice, said swab with specimen collection tip and handle, said tip and handle joined by a frangible shaft with breakpoint, said body with external surfaces and internal hollow volume, said external surfaces with disposable skin or skins, said swab receiving orifice with sealable closure;

b) using said swab to collect a biohazardous sample and inserting said specimen collection tip into said swab receiving orifice to the breakpoint on the handle;

c) breaking off the swab handle at the breakpoint and sealing the swab specimen collection tip within the body of the device by closing the sealable closure over the swab receiving orifice;

d) removing said disposable skin or skins from said external surfaces immediately after the sample collection process is completed and before further processing and transport; and

,

e) performing an analysis of said biohazardous sample by self-contained, integrated analysis means and displaying a result.

24. A method for collecting a biohazardous sample, comprising the steps of:

a) providing a swab and a microfluidic analytical device with body and with swab receiving orifice, said swab with specimen collection tip and handle, said tip and handle joined by a frangible shaft with breakpoint, said body with external surfaces and internal hollow volume, said external surfaces with disposable skin or skins, said swab receiving orifice with sealable closure;

b) using said swab to collect a biohazardous sample and inserting said specimen collection tip into said swab receiving orifice to the breakpoint on the handle;

c) breaking off the swab handle at the breakpoint and sealing the swab specimen collection tip within the body of the device by closing the sealable closure over the swab receiving orifice;

d) removing said disposable skin or skins from said external surfaces immediately after the sample collection process is completed and before further processing and transport; and

,

e) performing at least one sample processing step on said biohazardous sample.

25. A method for collecting a biohazardous sample, comprising the steps of:

a) providing a swab and a specimen collection container with body and with swab receiving orifice, said swab with specimen collection tip and handle, said tip and handle joined by a frangible shaft with breakpoint, said body with external surfaces and internal hollow volume, said external surfaces with disposable skin or skins, said swab receiving orifice with sealable closure;

b) using said swab to collect a biohazardous sample and inserting said specimen collection tip into said swab receiving orifice to the breakpoint on the handle;

c) breaking off the swab handle at the breakpoint and sealing the swab specimen collection tip within the body of the device by closing the sealable closure over the swab receiving orifice; and

,

d) removing said disposable skin or skins from said external surfaces immediately after the sample collection process is completed and before further processing and transport.

26. A method for collecting a biohazardous sample, comprising the steps of:

a) providing a sample and a specimen collection container with body and with sample receiving orifice, said body with external surface and internal hollow volume, said external surface with disposable skin or skins, said sample receiving orifice with sealable closure;

b) inserting said sample into said sample receiving orifice;

c) closing said sealable closure said sample receiving orifice;

thereby capturing said sample; and

,

d) removing said disposable skin or skins from said external surface;

thereby renewing said external surface immediately after the sample collection process is completed and before further processing and transport.

27. The steps, features, integers, compositions and/or compounds disclosed herein or indicated in the specification of this application individually or collectively, and any and all combinations of two or more of said steps or features.