Diagnostic testing device

• US 6,150,178 A
• Filed: 03/24/1999
• Issued: 11/21/2000
• Est. Priority Date: 03/24/1999
• Status: Expired due to Term

• Current Assignee: Avitar, Inc.
• Original Assignee: Avitar, Inc.
• Inventors: Phildius, Peter P., Cesarczyk, Edward J.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/275,476
• Time in Patent Office: 608 Days
• Field of Search: 422/58, 422/61, 422/100, 422/101, 436/165, 436/169, 436/177-178
• 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: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 33/521 Single-layer analytical elements

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 housing is moved with respect to the handle and the foam member is moved inside the housing and slid past the test membrane. In so doing, specimen is delivered to the test membrane. 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:

a housing having a bore and retaining members in the bore for receiving at least one membrane, the membrane carrying diagnostic test chemistry;

at least one hollow handle member being dimensioned to be slidably received in the bore of the housing; and

an elongated foam member having a length along a longitudinal axis and being circumscribed by the handle member along a portion of the length, the foam member having a portion protruding from an end of the handle member for collecting specimen, the protruding portion being dimensioned to be slidably received in the bore of the housing for making contact with the membrane after collecting the specimen,

whereby the foam member is protruding from the housing for sample collection and the protruding portion of the foam member is drawn across the membrane as the handle member is drawn through the bore of the housing, thereby delivering the collected specimen to the membrane.

2. The specimen collecting and testing device of claim 1,

wherein the housing is made of paper or plastic.

3. 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.

4. The specimen collecting and testing device of claim 1,

wherein the hollow handle member is made of paper or plastic.

5. The specimen collecting and testing device of claim 1,

wherein the foam member comprises a polyurethane foam.

6. The specimen collecting and testing device of claim 1,

wherein the foam member protrudes from an end of the handle member a distance of about 25% to about 400% of mean diameter of an uncompressed cross sectional area of the foam member.

7. The specimen collecting and testing device of claim 1,

further comprising a retaining member dimensioned to sidably receive an end of the housing, the retaining member for mechanically preventing the membrane from sliding from the bore of the housing.

8. The specimen collecting and testing device of claim 7,

wherein the retaining member further comprises one of a tab or a slot, and

wherein the housing contains one of a mating tab or slot for receiving the tab or the slot on the retaining member for maintaining said retaining member on the housing.

9. The specimen collecting and testing device of claim 2,

wherein the housing comprises a transparent plastic.

10. The specimen collecting and testing device of claim 1,

wherein the handle member comprises a plurality of handle members that may all be slidably received in the bore of the housing at the same time.

11. The specimen collecting and testing device of claim 1,

wherein the membrane further comprises a retaining clip for holding the membrane in the bore of the housing.

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

providing a specimen collecting and testing device including

a housing having a bore and retaining members in the bore for receiving at least one membrane, the membrane carrying diagnostic test chemistry,

at least one hollow handle member being dimensioned to be slidably received in the bore of the housing, and

an elongated foam member having a length along a longitudinal axis and being circumscribed by the handle member along a portion of the length, the foam member having a portion protruding from an end of the handle member and housing for collecting specimen, the protruding portion being dimensioned to be slidably received in the bore of the housing for making contact with the membrane after collecting the specimen;

wetting the protruding portion of the foam member with specimen; and

sliding the hollow handle member through the bore of the housing, thereby drawing the protruding portion of the wetted foam member across the membrane and delivering the collected specimen to the membrane.

13. The method of claim 12,

wherein the step of providing at least one hollow handle member comprises providing a plurality of handle members, and

wherein the step of sliding the handle member through the bore of the housing comprises sliding all of the handle members through the bore at the same time.

14. The method of claim 12,

further comprising the step of removing the membrane from the housing after the delivery of the specimen for further processing.

15. A specimen collecting and testing device comprising:

a housing member having a first end and a second end and a bore therethrough connecting said first and second ends;

at least one membrane carrying diagnostic test chemistry and including a face portion for receiving specimen; and

an elongated foam member having a length along a longitudinal axis and an end portion for collecting specimen,

wherein the housing member circumscribes a portion of the elongated foam member and is adapted to receive and hold the face portion of the membrane in contact with the elongated foam member, thereby enabling delivery of the specimen to the membrane within the housing member whereby the foam member protrudes form the housing for sample collection.

16. The specimen collecting and testing device of claim 15,

further comprising

a membrane holder having a portion with a forward face adapted to be received in mating fashion inside the bore at the first end of the housing, the portion adapted to be received in the bore further carrying the membrane with the face portion of the membrane disposed on the forward face,

wherein the circumscribed portion of the foam member is received in mating fashion inside the bore from the second end of the housing, and

wherein the circumscribed portion of the foam member at least partially contacts the face portion of the membrane when the membrane holder is inserted into the bore at the first end of the housing.

17. The specimen collecting and testing device according to claim 15,

wherein the housing is made of paper or plastic.

18. The specimen collecting and testing device according to claim 15,

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.

19. The specimen collecting and testing device of claim 16,

wherein the membrane holder member is made of paper or plastic.

20. The specimen collecting and testing device of claim 15,

wherein the foam member comprises a polyurethane foam.

21. The specimen collecting and testing device of claim 15,

wherein the foam member protrudes from the second end of the housing a distance of about 25% to about 400% of mean diameter of an uncompressed cross sectional area of the foam member.

22. The specimen collecting and testing device of claim 17,

wherein the housing comprises a transparent plastic.

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

providing a specimen collecting and testing device comprising

a housing member having a first end and a second end and a bore therethrough connecting said first and second ends,

at least one membrane carrying diagnostic test chemistry and including a face portion for receiving specimen, and

an elongated foam member having a length along a longitudinal axis and an end portion which protrudes from the housing for collecting the specimen,

wherein the housing member circumscribes a portion of the elongated foam member and is adapted to receive and hold the face portion of the membrane in contact with the elongated foam member, thereby enabling delivery of the specimen to the membrane within the housing member;

wetting the end portion of the foam member with specimen; and

delivering the specimen to the membrane by capillary action.

24. The method of claim 23,

wherein the step of providing a specimen collecting and testing device further comprises

providing a membrane holder having a portion with a forward face adapted to be received in mating fashion inside the bore at the first end of the housing, the portion adapted to be received in the bore further carrying the membrane with the face portion of the membrane disposed on the forward face,

wherein the circumscribed portion of the foam member is adapted to be received in mating fashion inside the bore from the second end of the housing, and

wherein the circumscribed portion of the foam member at least partially contacts the face portion of the membrane when the membrane holder is inserted into the bore at the first end of the housing.

25. A specimen collecting and testing device comprising:

a handle member having a first end and a second end and a bore therethrough;

at least one membrane carrying diagnostic test chemistry;

an elongated foam member having a length along a longitudinal axis and an uncompressed cross sectional area in a plane perpendicular to the longitudinal axis,

wherein the handle member is adapted to removably receive a first portion of the elongated foam member at the first end thereof and the foam member has a second portion protruding from the first end for collecting specimen; and

a housing member adapted to receive the membrane and comprising a bore slidably receiving the handle member, wherein the handle member is adapted to be adjusted to protrude form the housing for collecting the specimen and adapted to be withdrawn from the housing member for contacting the protruding second portion of the foam member to the membrane, thereby delivering the specimen to the membrane.

26. The specimen collecting and testing device of claim 25,

wherein the handle member further comprises a handle cap at the second end.

27. The specimen collecting and testing device of claim 25,

wherein the handle member and the housing member are made of paper or plastic.

28. The specimen collecting and testing device according to claim 25,

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.

29. The specimen collecting and testing device of claim 25,

further comprising a security hood attached to the housing member.

30. The specimen collecting and testing device of claim 25,

wherein the foam member comprises a polyurethane foam.

31. The specimen collecting and testing device of claim 25,

wherein the foam member protrudes from the first end of the handle member a distance of about 25% to about 400% of mean diameter of the uncompressed cross sectional area of the foam member.

32. The specimen collecting and testing device of claim 25,

wherein the housing member comprises a transparent plastic.

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

providing a specimen collecting and testing device comprising

a handle member having a first end and a second end and a bore therethrough,

at least one membrane carrying diagnostic test chemistry,

an elongated foam member having a length along a longitudinal axis and an uncompressed cross sectional area in a plane perpendicular to the longitudinal axis,

wherein the handle member is adapted to removably receive a first portion of the elongated foam member at the first end thereof and the foam member has a second portion protruding from the first end for collecting specimen, and

a housing member adapted to receive the membrane and comprising a bore slidably receiving the handle member, wherein the handle member is adapted to be adjusted to protrude form the housing for collecting the specimen and adapted to be withdrawn from the housing member for contacting the protruding second portion of the foam member to the membrane, thereby delivering specimen to the membrane;

wetting the protruding second portion of the foam member with specimen; and

delivering the specimen to the membrane by capillary action.

34. A specimen collecting and testing device comprising:

at least one membrane carrying diagnostic test chemistry;

an elongated foam member having a length along a longitudinal axis and an uncompressed cross sectional area in a plane perpendicular to the longitudinal axis; and

a housing member circumscribing a portion of the elongated foam member which is adapted to protrude from the housing, and the housing member is adapted to receive and hold said membrane for contact with the elongated foam member,

whereby a fluid sample collected by the foam member is transferred to said membrane for diagnostic testing.