Collection device for biological samples and methods of use

• US 6,036,659 A
• Filed: 10/09/1998
• Issued: 03/14/2000
• Est. Priority Date: 10/09/1998
• Status: Expired due to Term

• Current Assignee: Healthpoint Diagnostix Incorporated
• Original Assignee: Flexsite Diagnostics, Inc.
• Inventors: Sarzo, Raul, Ray, Robert A., Stangarone, Robert, Peddicord, Julie
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/169,843
• Time in Patent Office: 522 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. A device for quantitative remote-site collection and drying of a liquid biological sample obtained from an individual for the purpose of mailing for recovery and laboratory analysis of an analyte contained in the biological sample, said device comprising:

a separation member which selectively separates and retains an undesired component in the sample from a component of interest containing analyte; and

a non-reactive collection member for collecting and drying the separated analyte-containing component of interest, wherein said dried collection member can be later at least partially removed from the device to recover the analyte-containing component for laboratory analysis of analyte.

2. The device of claim 1 wherein the biological sample is whole blood and the component of interest is plasma or serum.

3. The device of claim 1 wherein the separation member is capable of separating and substantially permanently retaining cellular components in the biological sample without leaching of said cellular components into the collection member.

4. The device of claim 1 wherein the separation member is an absorbent filter material.

5. The device of claim 1 wherein the separation material is selected from glass fiber, glass fiber/cellulose mixtures, cellulose, or synthetic materials.

6. The device of claim 4 wherein the separation member is glass fiber.

7. The device of claim 1 wherein the collection member is made from a material selected from cellulose, polypropylene, nylon, polyester, modified polyester, polyethersulfone, nitrocellulose, high density polyethylene, or a composite of natural and synthetic fibers.

8. The device of claim 1 wherein at least one of said members is pre-treated with a reagent which facilitates the collection, separation, storage, transport, preservation, recovery, or analysis of the sample.

9. The device of claim 1 further comprising a substantially impermeable cover.

10. The device of claim 9 wherein said cover further comprises an aperture which is superimposed over the top face of a separation member when the cover is placed in position on the device.

11. The device of claim 1 further comprising a quantitation member in contact or fluid communication with the separation member for quantitatively delivering the sample to the separation member.

12. The device of claim 11 wherein the quantitation member is a capillary tube.

13. The device of claim 11, wherein the quantitation member is a non-absorbent screen material.

14. The device of claim 11, wherein the quantitation member is a track-etched membrane.

15. The device of claim 1 wherein the analyte is selected from bone alkaline phosphatase, cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, fructosamine, and alanine amino transferase.

16. The device of claim 1 wherein said device comprises a plurality of collection members in contact or fluid communication with a single separation member.

17. The device of claim 1 wherein said device comprises a plurality of separation members.

18. The device of claim 1, said device further comprising an overflow member to absorb excess volume of liquid sample.

19. A method for quantitative remote-site collection of a biological sample and laboratory analysis of an analyte in the sample, said method comprising:

providing a collection device to an individual or a health care professional, said device comprising a separation member which selectively separates and retains an undesired component in the sample from the component of interest containing the analyte, and a separable collection member for collecting the analyte-containing component of interest which has been separated from the undesired component, wherein said separation member and collection member are in contact or fluid communication with one another for delivering the analyte-containing component of interest from the separation member to the collection member;

applying the biological sample in liquid form to the device so that the analyte-containing component of interest is quantitatively collected onto the collection member;

drying said collection member having the analyte-containing component of interest collected thereon;

transporting the collection member to a facility for analysis of the analyte;

removing the collection member from the device;

eluting the analyte from the collection member;

determining presence, absence, or concentration of the analyte; and

reporting results of the analysis to the individual or health care professional.

20. The method of claim 19 wherein the drying step can be completed before the step of removing the collection member.

21. The method of claim 19 further comprising identifying the individual and sample by a code.

22. The method of claim 19 wherein the elution step is modified according to the particular component of interest being determined.

23. The method of claim 19 wherein the step of determining presence, absence, or concentration of the analyte is modified according to said particular component.

24. A kit for quantitative remote-site collecting of a biological sample from a patient for laboratory analysis of said sample, said kit comprising:

a device for quantitative remote-site collection and drying of a liquid biological sample obtained from an individual for the purpose of mailing for recovery and laboratory analysis of an analyte contained in the biological sample;

a separation member which selectively separates and retains an undesired component in the sample from a component of interest containing analyte;

a non-reactive collection member for collecting and drying the separated analyte-containing component of interest, wherein said dried collection member can be later at least partially removed from the device to recover the analyte-containing component for laboratory analysis of analyte; and

an information card for providing information about the patient.

25. The kit of claim 24 wherein said kit further comprises a component selected from a lancet, antiseptic swab, and packaging means for transporting the collected sample.