Diagnostic testing device and method of use thereof

• US 20020106809A1
• Filed: 02/06/2001
• Published: 08/08/2002
• Est. Priority Date: 02/06/2001
• Status: Active Grant

• Current Assignee: Avitar, Inc.
• Original Assignee: Avitar, Inc.
• Inventors: Cesarczyk, Edward J.
• Granted Patent: US 6,821,788 B2
• Time in Patent Office: Days
• US Class Current: 436/165
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A specimen collecting and testing device has a housing containing a test membrane. An elongated handle having a foam member is slidably received in the housing. Once the foam member obtains a specimen, the device is held vertically with the foam member pointing upwards and the handle with the foam member is drawn through the housing. In so doing, specimen is expelled from the foam member and delivered to a fluid chamber positioned along the test membrane. The device is then positioned horizontally and specimen that collects in the fluid chamber passes through an aperture in the fluid chamber and onto the test membrane located beneath the aperture. The test membrane may then be observed for optical changes in the case of an instant-type test, or removed for further processing. The device is particularly useful for collecting samples of urine or oral fluid for use in drug testing, pregnancy testing and the like; for testing of specimen for any of a variety of analytes such as HIV, hepatitis B, hepatitis C, etc.; and, for collecting samples of DNA for PCR testing.

Claims

1. A specimen collecting and testing device comprising:

an elongate, hollow housing having a proximal end and a distal end;

at least one test membrane or sample collecting strip positioned within the housing, the test membrane carrying diagnostic test chemistry;

a fluid chamber, for holding specimen, positioned adjacent to the test membrane or sample collecting strip;

at least one elongate handle member, having a proximal end and a distal end, slidably received in the housing; and

a foam member, for collecting specimen, extending from the proximal end of the handle whereby, when the handle is drawn through the housing, collected specimen is deposited from the foam member into the fluid chamber and onto the test membrane or sample collecting strip.

2. The specimen collecting device of claim 1 further comprising an aperture in the fluid chamber through which specimen deposited in the fluid chamber passes onto the test membrane or sample collecting strip.

3. The specimen collecting and testing device of claim 1 further comprising a barrier or compression area on the proximal side of the fluid chamber, whereby, as the handle is drawn through the housing, the foam member contacts and is compressed by the barrier or compression area, thereby expelling specimen that is collected by the foam member into the fluid chamber.

4. The specimen collecting and testing device of claim 1, further comprising a barrier or compression area, whereby the barrier or compression area assists in extracting specimen of various viscosities from the foam member.

5. The specimen collecting and testing device of claim 4, wherein the barrier or compression area is V-shaped, U-shaped, straight, flat and/or chamfered.

6. The specimen collecting device of claim 1 further comprising a backup chamber, whereby specimen in excess to the capacity of the fluid chamber flows into the backup chamber.

7. The specimen collecting device of claim 1, wherein a barrier forms the distal side of the fluid chamber and prevents specimen deposited in the fluid chamber from flowing over or around the barrier onto the test membrane.

8. The specimen collecting device of claim 1 wherein a barrier forms the proximal end of the fluid chamber and is sized to meter the amount of specimen in the fluid chamber.

9. The specimen collecting and testing device of claim 1, wherein the elongate, hollow housing has an outer surface with at least one flat area, whereby, when the specimen collecting and testing device is placed on a surface, the at least one flat area prevents the specimen collecting and testing device from rolling.

10. The specimen collecting and testing device of claim 1, wherein the housing is made of plastic.

11. The specimen collecting and testing device of claim 1, wherein the foam member comprises a material selected from the group consisting of polyurethane foam, polyethylene foam, polyvinylchloride foam, ethylvinylacetate foam, polyethylene/ethylvinylacetate foam, polyester foam and polyether foam.

12. The specimen collecting and testing device of claim 11, wherein the foam member comprises a polyurethane foam.

13. The specimen collecting and testing device of claim 1, wherein the handle member is hollow.

14. The specimen collecting and testing device of claim 13, wherein a portion of the foam member is disposed in the hollow handle member.

15. The specimen collecting and testing device of claim 1, wherein the handle member is made of paper or plastic.

16. The specimen collecting and testing device of claim 1, wherein the foam member extends from an end of the handle member a distance of about 25% to about 400% of a mean diameter of the handle or a mean diameter of an uncompressed cross sectional area of the foam member.

17. The specimen collecting and testing device of claim 1, wherein at least a portion of the housing comprises a transparent material such that the test membrane can be viewed through the portion of the housing.

18. The specimen collecting and testing device of claim 1, wherein at least a portion of the housing is removable, such that the test membrane or sample collecting strip can be viewed or removed through the removable portion of the housing.

19. The specimen collecting and testing device of claim 1, wherein at least a portion of the housing is open, such that the test membrane or sample collecting strip can be viewed through or removed through the open portion of the housing.

20. The specimen collecting and testing device of claim 1, wherein the at least one test membrane or sample collecting strip is removably positioned within the housing.

21. The specimen collecting and testing device of claim 1 wherein the sample collecting strip is impregnated with preservatives.

22. A method of collecting a sample of fluid specimen for diagnostic testing, the method comprising:

providing a specimen collecting and testing device including;

an elongate, hollow housing having a proximal end and a distal end;

at least one test membrane or sample collecting strip positioned within the housing, the test membrane carrying diagnostic test chemistry;

a fluid chamber, for holding specimen, positioned adjacent to the test membrane or sample collecting strip;

an aperture in the fluid chamber positioned adjacent to the test membrane or sample collecting strip;

at least one elongate handle member, having a proximal end and a distal end, slidably received in the housing; and

a foam member, for collecting specimen, extending from the proximal end of the handle;

wetting the foam member with specimen;

positioning the device vertically with the foam member extending upwards;

sliding the handle member through the housing, thereby drawing the wetted foam member across the fluid chamber and delivering the collected specimen to the fluid chamber; and

positioning the device horizontally so as to level off the specimen in the fluid chamber and allow the specimen to flow through the aperture and onto the test membrane or sample collecting strip.

23. The method of claim 22, wherein the specimen collecting and testing device further comprises a barrier or compression area on the proximal side of the fluid chamber, the method further comprising compressing the foam member by the barrier or compression area, thereby expelling collected specimen which flows downwards into the fluid chamber.

24. The method of claim 22, further comprising the step of removing the test membrane or sample collecting strip from the housing after the delivery of the specimen for further processing.

25. The method of claim 22, wherein the specimen collecting and testing device further includes a backup chamber proximate to the fluid chamber and wherein said step of positioning the device horizontally so as to level off the specimen in the fluid chamber further comprises allowing specimen in excess to the capacity of the fluid chamber to flow into the backup chamber.