Plasma separation card

Patent metadata

Field	Value
Publication number	US-10663379-B2
Application number	US-201615085882-A
Country	US
Kind code	B2
Filing date	Mar 30, 2016
Priority date	Mar 31, 2015
Publication date	May 26, 2020
Grant date	May 26, 2020

Abstract

A multi-layer plasma separation card comprising (a) a first layer including a sample receiving member comprising (i) a top planar surface for applying or receiving a blood sample, said sample receiving portion being adapted to permit contact of said blood sample with a separating member; and (ii) a bottom planar surface being adapted to contact said separating member, (b) a second layer including at least three separating members, each separating member being adapted to permit the passage of plasma to an absorptive member and comprising (i) a top planar surface for receiving said blood sample; and (ii) a bottom planar shield-shaped surface being adapted to contact said absorptive member, and (c) a third layer including at least two absorptive members for absorbing plasma from the bottom planar surface of each corresponding separating member and a backing member arranged in a manner to support said absorptive members, each absorptive member comprising a removable absorptive element having a top planar surface being adapted to contact said bottom planar surface of the separating member, said absorptive element is detachable fixed to the third layer.

First claim

The invention claimed is:

1. A multi-layer plasma separation card comprising:
(a) a first layer including at least three sample receiving portions comprising (i) a top planar surface for applying or receiving a blood sample, the sample receiving portions permitting contact of said blood sample with at least three separating members, wherein each of the sample receiving portions is an opening, wherein the size of each of the sample receiving portions is smaller than the size of each of the surfaces of the separating member or absorptive member, and (ii) a bottom planar surface contacting the at least three separating members,
(b) a second layer including the least three separating members, each of the three separating members permitting the passage of plasma to at least three absorptive members and comprising (i) a top planar surface for receiving the blood sample; and (ii) a bottom planar shield-shaped surface contacting the at least three absorptive members, and
(c) a third layer including the at least three absorptive members for absorbing plasma from the bottom planar surface of each of the corresponding at least three separating members, and a backing member arranged in a manner to support the at least three absorptive members, each of the at least three absorptive members comprising a removable absorptive element having a top planar surface being in contact with the bottom planar surface of the at least three separating members, the removable absorptive element being detachably fixed to the third layer,
wherein each of the removable absorptive element comprises a perforated border and at least two anchor elements, wherein the at least two anchor elements fix the removable absorptive element with the third layer.

2. The multi-layer plasma separation card of claim 1 , wherein the removable absorptive element of the third layer is part of a strip, wherein the strip further comprises a non-absorptive handle adjacent to the absorptive element.

3. The multi-layer plasma separation card according to claim 1 , wherein said absorptive element comprises at least two elements for fixing the removable absorptive element with the third layer.

4. The multi-layer plasma separation card according to claim 1 , comprising an additional layer comprising a plasma level control substance, wherein said additional layer is either directly in contact with or is positioned adjacent to the removable absorptive material.

5. The multi-layer plasma separation card according to claim 1 , wherein the size of each of the sample receiving portions is smaller than the size of each of the surfaces of the separating member or absorptive member.

6. The multi-layer plasma separation card according to claim 1 , wherein 10 μl to 1000 μl of a whole blood sample is applied on each of the sample receiving portions.

7. The multi-layer plasma separation card according to claim 1 , wherein the separating member comprises an asymmetric plasma separation membrane.

8. The multi-layer plasma separation card according to claim 1 , wherein the absorptive member is composed of a plasma collection material and optionally comprises a plasma stabilizer.

9. The multi-layer plasma separation card according to claim 1 , wherein the absorptive member comprises a fleece consisting of cotton linters with an average thickness of 300-420 μm.

10. The multi-layer plasma separation card according to claim 1 , wherein each of the absorptive elements comprises a longitudinally folded planar formation.

11. The multi-layer plasma separation card according to claim 1 , wherein the absorptive elements can be easily removed and/or transferred to a vessel for determination with a tweezers.

12. A package comprising a multi-layer plasma separation card according to claim 1 , further comprising a desiccant material in a hermetically sealed environment.

13. The multi-layer plasma separation card according to claim 1 , further comprising an intermediate layer in between the first layer and the second layer.

14. The multi-layer plasma separation card according to claim 13 , wherein the intermediate layer comprises a double-sided adhesive material for blocking or limiting the distribution of blood.

15. The multi-layer plasma separation card according to claim 1 , further comprising:
(d) a fourth layer, wherein the fourth layer is a carrier layer for protecting and stabilizing the multi-layer plasma separation card.

16. The multi-layer plasma separation card according to claim 15 , wherein the carrier layer comprises an adhesive material.

17. The multi-layer plasma separation card according to claim 1 , wherein the separating members comprise a grouted or compressed frame or border to avoid leakage of the blood sample.

18. The multi-layer plasma separation card according to claim 1 , wherein the absorptive members have perforated borders to allow for removal of the absorptive member from the third layer.

19. The multi-layer plasma separation card according to claim 1 , wherein the absorptive member comprises a removable absorptive element.

20. The multi-layer plasma separation card according to claim 19 , wherein the removable absorptive element contains one or more anchor elements.

21. The multi-layer plasma separation card according to claim 20 , wherein the anchor elements comprise a blocking element to avoid leakage of the plasma.

22. The multi-layer plasma separation card of claim 1 , wherein 10 μl to 1000 μl of a whole blood sample is applied on each of the sample receiving portions.

23. The multi-layer plasma separation card of claim 1 , wherein the opening is a substantially circular opening.

24. The multi-layer plasma separation card of claim 1 , wherein the absorptive member is composed of a plasma collection material and optionally comprises a plasma stabilizer.

25. The multi-layer plasma separation card of claim 1 , wherein the absorptive member comprises a fleece consisting of cotton linters with an average thickness of 300-420 μm.

26. The multi-layer plasma separation card of claim 1 , wherein the separating members comprise a grouted or compressed frame or border to avoid leakage of the blood sample.

Assignees

• Roche Molecular Systems Inc

Inventors

• Dick Siegfried
• Fischer Markus
• Schmelzer Alexander
• Trapp Andreas
• Will Stephen

Classifications

• G01N1/405 Primary

  by adsorption or absorption · CPC title

• G01N2001/4088

  filtration · CPC title

• G01N33/525

  Multi-layer analytical elements · CPC title

• C12Q1/703

  Viruses associated with AIDS · CPC title

• G01N33/491 Primary

  by separating the blood components (G01N15/05 takes precedence) · CPC title