Collection device for biological samples and methods of use

• US 6,258,045 B1
• Filed: 10/08/1999
• Issued: 07/10/2001
• Est. Priority Date: 10/09/1998
• Status: Expired due to Fees

• Current Assignee: Healthpoint Diagnostix Incorporated
• Original Assignee: Flexsite Diagnostics, Inc.
• Inventors: Stangarone, Robert, Peddicord, Julie, Ray, Robert A.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/415,304
• Time in Patent Office: 641 Days
• Field of Search: 600/573, 600/575, 600/584, 604/403, 604/406, 422/50, 422/56, 422/58, 436/74, 436/169, 436/170
• US Class Current: 600/573
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A device for remote-site biological sample collection for laboratory analysis is described. The device can be made in several configurations which all include separate members for collecting and separating the biological sample into its desired components which are detected or measured. Methods of use for the device are also described.

Claims

1. An apparatus for isolating an analyte from a blood sample, the apparatus comprising:

a separation member for receiving a portion of the blood sample, the separation member comprising a filter that selectively retains cellular components contained within the portion of the blood sample and delivers non-cellular components of the portion of the blood sample containing the analyte;

a wicking bridge fluidly connected to the separation member such that the wicking bridge can receive the non-cellular components of the portion of the blood sample containing the analyte from the separation member, the wicking bridge comprising a strip of porous material for transporting the non-cellular components of the portion of the blood sample containing the analyte away from the separation member; and

a quantitative collection member fluidly connected to the wicking bridge such that the quantitative collection member can receive the non-cellular components of the portion of the blood sample containing the analyte from the wicking bridge, the quantitative collection member being substantially free of any reactants for analyzing the analyte and comprising a swatch of material that is adapted for absorbing and retaining a specific quantity of the non-cellular components of the portion of the blood sample containing the analyte.

2. The apparatus of claim 1, wherein the separation member comprises a layer of glass fiber filter material and a layer of track-etched membrane.

3. The apparatus of claim 2, wherein the layer of track-etched membrane comprises at least one of polyester and polycarbonate and has a plurality of pores having a mean diameter of about 0.2 to 5.0 micron.

4. The apparatus of claim 3, wherein the track-etched membrane comprises polyester and the plurality of pores have a mean diameter of about one micron.

5. The apparatus of claim 1, wherein the separation member is impregnated with a surfactant.

6. The apparatus of claim 5, wherein the surfactant is a polyoxyethylene sorbitan ester.

7. The apparatus of claim 1, wherein the separation member is impregnated with a protein that reduces adsorption of components of the blood sample to the separation member.

8. The apparatus of claim 7, wherein the protein is bovine serum albumin.

9. The apparatus of claim 1, wherein the separation member is impregnated with an erythrocyte agglutinin.

10. The apparatus of claim 9, wherein the agglutinin is a lectin.

11. The apparatus of claim 9, wherein the agglutinin is an antibody that specifically binds to erythrocytes.

12. The apparatus of claim 1, wherein the wicking bridge comprises a fibrous polyester matrix.

13. The apparatus of claim 1, wherein the quantitative collection member comprises a layer of glass fiber filter material.

14. The apparatus of claim 1, wherein the quantitative collection member comprises a layer of nylon.

15. The apparatus of claim 14, wherein the quantitative collection member further comprises a layer of material selected from the group consisting of glass fiber filter material and cellulose.

16. The apparatus of claim 1, wherein the apparatus comprises a second quantitative collection member, the second quantitative collection member being fluidly connected to the wicking bridge such that the second quantitative collection member can receive the non-cellular components of the portion of the blood sample containing the analyte from the wicking bridge, substantially free of any reactants for analyzing the analyte, and comprised of a swatch of material that is adapted for absorbing and retaining a specific quantity of the non-cellular components of the portion of the blood sample containing the analyte.

17. The apparatus of claim 16, wherein the apparatus comprises a third quantitative collection member, the third quantitative collection member being fluidly connected to the wicking bridge such that the third quantitative collection member can receive the non-cellular components of the portion of the blood sample containing the analyte from the wicking bridge, substantially free of any reactants for analyzing the analyte, and comprised of a swatch of material that is adapted for absorbing and retaining a specific quantity of the non-cellular components of the portion of the blood sample containing the analyte.

18. The apparatus of claim 1, wherein said apparatus further comprises an application member fluidly connected to the separation member, the application member comprising a swatch of material having a plurality of pores for absorbing the blood sample and delivering a portion of the blood sample to the separation member.

19. The apparatus of claim 18, wherein the application member comprises polyester screen.

20. The apparatus of claim 18, wherein the application member is impregnated with a protein that reduces adsorption of components of the blood sample to the application member.

21. The apparatus of claim 20, wherein the protein is bovine serum albumin.

22. The apparatus of claim 18, wherein the application member is impregnated with a surfactant.

23. The apparatus of claim 22, wherein the surfactant is a polyoxyethylene sorbitan ester.

24. The apparatus of claim 18, wherein the application member is impregnated with an erythrocyte agglutinin.

25. The apparatus of claim 24, wherein the agglutinin is a lectin.

26. The apparatus of claim 24, wherein the agglutinin is an antibody that specifically binds to erythrocytes.

27. The apparatus of claim 18, the apparatus further comprising a casing which houses the application member, the separation member, the wicking bridge, and the quantitative collection member;

the casing having an opening for applying the blood sample to the application member.

28. The apparatus of claim 27, wherein the casing comprises two pieces of a fluid impermeable plastic material sealed together in an airtight manner such that gas exchange between the ambient atmosphere, the application member, the separation member, the wicking bridge, and the quantitative collection member occurs almost entirely through the opening of the casing.

29. The apparatus of claim 28, the apparatus further comprising an impermeable spacer interposed between the wicking bridge and the application member, the impermeable spacer having a thickness of about 5.0 mm (0.020 inches) and having a first perforation through the thickness for accommodating the separation member and a second perforation through the thickness for accommodating the quantitative collection member.

30. The apparatus of claim 29, wherein the first perforation and the second perforation each have a diameter of about 4.75 mm (0.1875 inches), and the separation member and the quantitative collection member each have a diameter of about 4.65 mm (0.1825 inches).

31. The apparatus of claim 27, the apparatus further comprising an identification label attached to the casing, the identification label for displaying information indicating the source of blood sample.

32. The apparatus of claim 31, wherein the identification label includes a bar code.

33. The apparatus of claim 18, wherein

the application member comprises polyester impregnated with at least one protein that reduces adsorption of components of blood sample to the application member and at least one agglutinin;

the separation member comprises a layer of glass fiber filter material and a layer of polyester track-etched membrane;

the wicking bridge comprises a fibrous polyester matrix; and

the quantitative collection member comprises a layer of nylon and a layer of glass fiber filter material.

34. An apparatus for isolating an analyte from a blood sample, the apparatus comprising:

a capillary tube for quantitatively aspirating a specific volume of the blood sample and delivering a specific volume of a portion of the blood sample to the separation member;

a separation member fluidly connected to the capillary tube such that the separation member can receive the specific volume of the portion of the blood sample from the capillary tube, the separation member comprising a filter that selectively retains cellular components of the portion of the blood sample and delivers non-cellular components of the portion of the blood sample containing the analyte;

a wicking bridge fluidly connected to the separation member such that the wicking bridge can receive the non-cellular components of the portion of the blood sample containing the analyte from the separation member, the wicking bridge comprising a strip of porous material for transporting the non-cellular components of the portion of the blood sample containing the analyte away from the separation member; and

a quantitative collection member fluidly connected to the wicking bridge such that the quantitative collection member can receive the non-cellular components of the portion of the blood sample containing the analyte from the wicking bridge, the quantitative collection member being substantially free of any reactants for analyzing the analyte and comprising a swatch of material that is adapted for absorbing and retaining a specific quantity of the non-cellular components of the portion of the blood sample containing the analyte.

35. A kit for isolating an analyte from a sample of blood, the kit comprising:

an apparatus comprising

a separation member for receiving a predetermined volume of the blood sample, the separation member comprising a filter that selectively retains cellular components of the portion of the blood sample and delivers non-cellular components of the portion of the blood sample containing the analyte;

a wicking bridge fluidly connected to the separation member such that the wicking bridge can receive the non-cellular components of the portion of the blood sample containing the analyte from the separation member, the wicking bridge comprising a strip of porous material for transporting the non-cellular components of the portion of the blood sample containing the analyte away from the separation member; and

a quantitative collection member fluidly connected to the wicking bridge such that the quantitative collection member can receive the non-cellular components of the portion of the blood sample containing the analyte from the wicking bridge, the quantitative collection member being substantially free of any reactants for analyzing the analyte and comprising a swatch of material that is adapted for absorbing and retaining a specific quantity of the non-cellular components of the portion of the blood sample containing the analyte; and

a quantitative fluid dispenser for delivering the predetermined volume of the sample of the blood to the separation membrane.

36. The kit of claim 35, wherein said quantitative fluid dispenser is a micropipet.

37. The kit of claim 35, wherein said quantitative fluid dispenser is a capillary tube.

38. A kit for isolating an analyte from a blood sample, the kit comprising:

an apparatus comprising

a separation member for receiving an aliquot of the blood sample, the separation member comprising a filter that selectively retains cellular components of the portion of the blood sample and delivers non-cellular components of the portion of the blood sample containing the analyte;

a wicking bridge fluidly connected to the separation member such that the wicking bridge can receive the non-cellular components of the portion of the blood sample containing the analyte from the separation member, the wicking bridge comprising a strip of porous material for transporting the non-cellular components of the portion of the blood sample containing the analyte away from the separation member; and

a quantitative collection member fluidly connected to the wicking bridge such that the quantitative collection member can receive the non-cellular components of the portion of the blood sample containing the analyte from the wicking bridge, the quantitative collection member being substantially free of any reactants for analyzing the analyte and comprising a swatch of material that is adapted for absorbing and retaining a specific quantity of the non-cellular components of the portion of the blood sample containing the analyte; and

a lancet; and

an antiseptic.

39. The kit of claim 38, the kit further comprising:

instructions for using the kit; and

a bar-coded identification card.