Whole blood separation method and devices using the same

• US 5,725,774 A
• Filed: 04/07/1995
• Issued: 03/10/1998
• Est. Priority Date: 04/07/1995
• Status: Expired due to Term

• Current Assignee: LXN Corporation (Johnson & Johnson)
• Original Assignee: LXN Corporation (Johnson & Johnson)
• Inventors: Neyer, Gebhard
• Primary Examiner(s): Kim, John
• Application Number:
  US08/418,523
• Time in Patent Office: 1,068 Days
• Field of Search: 210/483, 210/488, 210/489, 210/490, 210/496, 210/503, 210/504, 210/505, 210/506, 210/508, 210/767, 210/645, 210/650, 210/651, 210/806, 422/55, 422/56, 422/57, 422/60, 422/73, 422/101, 422/102, 436/16, 436/69, 436/169, 436/170, 436/177, 436/178, 530/412, 530/415
• US Class Current: 210/645
• CPC Class Codes: B01D 39/1623 of synthetic origin
• CPC Class Codes: B01D 39/18 the material being cellulose or derivatives thereof cork or peat B01D39/1646 ; making filter paper D21F11/14
• CPC Class Codes: B01D 69/10 Supported membranes; Membrane supports
• CPC Class Codes: B01D 69/1071 Woven, non-woven or net mesh
• CPC Class Codes: D04H 1/435 Polyesters
• CPC Class Codes: D04H 13/00 Other non-woven fabrics
• CPC Class Codes: G01N 33/5002 Partitioning blood components
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/526 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• 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

Abstract

The present invention relates to a method and to a device for separating plasma from whole blood. The method and device utilize a permeable non-glass fiber matrix containing a polyol which is capable of clumping red blood cells. The matrix, in the absence of such a polyol, would otherwise be porous to red blood cells. The polyol-containing matrix has a first surface and a second surface such that a whole blood sample which is applied to the first surface flows directionally toward the second surface. Plasma separated from whole blood becomes available at the second surface of the matrix and can be tested for the presence of a particular analyte, such as glucose or fructosamine, as provided by multi-layer test devices of the present invention.

Claims

1. A process for separating plasma from a whole blood sample, comprising:

(a) applying the whole blood sample to a first surface of a permeable non-glass fiber matrix containing (1) a C₃ to C₂₀ polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol;

(b) flowing said whole blood sample under conditions which allow said sample to flow vertically toward a second surface of said matrix, said first and second surfaces being on opposite sides of said matrix; and

(c) receiving plasma separated from said whole blood sample at said second surface.

2. The process of claim 1, wherein the polycationic polymer is hexadimethrine bromide.

3. The process of claim 1, wherein said matrix is supported by a permeable filter material.

4. The process of claim 3, wherein the permeable filter material is a reagent layer containing at least one chemical reagent for determining the presence of an analyte in the plasma.

5. The process of claim 4, wherein said chemical reagent provides a color determination.

6. The process of claim 4, wherein determining the presence of an analyte is a quantitative determination.

7. The process of claim 3, wherein the permeable filter material is selected from the group consisting of a nylon, a cellulose acetate, a polysulfone, a synthetic fiber, and a polycarbonate.

8. The process of claim 1, wherein the polyhydroxy alcohol is impregnated in the matrix.

9. The process of claim 1, wherein the matrix is selected from the group consisting of a polyester, a nylon, a rayon, and a cotton.

10. The process of claim 1, wherein the matrix is a non-woven, non-absorbent polyester.

11. The process of claim 10, wherein the polyester is a poly(paraphenylene terephthalate).

12. The process of claim 1, wherein the polyhydroxy alcohol is present in a concentration of about 10%.

13. A device for separating plasma from a whole blood sample, comprising a permeable non-glass fiber matrix containing (1) a C₃ to C₂₀ polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol, said matrix further having a first surface and a second surface which are on opposite sides of said matrix, wherein the whole blood sample vertically flows from said first surface toward said second surface and wherein plasma separated from a whole blood sample becomes available at said second surface.

14. The device of claim 13, wherein the polycationic polymer is hexadimethrine bromide.

15. The device of claim 13, wherein the matrix is supported by a permeable filter material.

16. The device of claim 15, wherein the permeable filter material is a reagent layer containing at least one chemical reagent for determining the presence of an analyte in the plasma.

17. The device of claim 15, wherein the permeable filter material is selected from the group consisting of a nylon, a cellulose acetate, a polysulfone, a synthetic fiber, and a polycarbonate.

18. The device of claim 13, wherein the polyhydroxy alcohol is impregnated in the matrix.

19. The device of claim 13, wherein the matrix is selected from the group consisting of a polyester, a nylon, a rayon, and a cotton.

20. The device of claim 13, wherein the matrix is a non-woven, non-absorbent polyester.

21. The device of claim 20, wherein the polyester is a poly(paraphenylene terephthalate).

22. The device of claim 13, wherein the polyhydroxy alcohol is present in a concentration of about 10%.

23. A device for separating plasma from a whole blood sample, comprising:

(a) a non-woven, non-absorbent polyester matrix impregnated with mannitol and hexadimethrine bromide, said matrix being porous to red blood cells in the absence of said mannitol and said matrix further having a first surface and a second surface which are on opposite sides of said matrix, wherein the whole blood sample vertically flows from said first surface toward said second surface and wherein plasma separated from the whole blood sample becomes available at said second surface; and

(b) a nylon membrane supporting said matrix.

24. The device of claim 23, wherein mannitol is present in a concentration of about 10%.

25. A process for separating plasma from a whole blood sample, comprising:

(a) applying the whole blood sample to a first surface of a permeable non-glass fiber matrix containing (1) a C₃ to C₂₀ polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol;

(b) flowing said whole blood sample under conditions which allow said sample to flow directionally toward a second surface of said matrix; and

(c) receiving plasma separated from said whole blood sample at said second surface.

26. The process of claim 25, wherein the polyhydroxy alcohol is mannitol and further wherein the polycationic polymer is hexadimethrine bromide.

27. The process of claim 25, wherein the polyhydroxy alcohol is present in a concentration of about 10%.

28. A device for separating plasma from a whole blood sample, comprising a permeable non-glass fiber matrix containing (1) a C₃ to C₂₀ polyhydroxy alcohol capable of clumping red blood cells and (2) a polycationic polymer, said matrix being porous to red blood cells in the absence of said polyhydroxy alcohol, said matrix further having a first surface and a second surface, wherein the whole blood sample is applied to said first surface and flows directionally toward said second surface and further wherein plasma separated from a whole blood sample becomes available at said second surface.

29. The device of claim 28, wherein the polyhydroxy alcohol is mannitol and further wherein the polycationic polymer is hexadimethrine bromide.

30. The process of claim 28, wherein the polyhydroxy alcohol is present in a concentration of about 10%.