Plasma separation card

Patent metadata

Field	Value
Publication number	US-11353382-B2
Application number	US-202016843130-A
Country	US
Kind code	B2
Filing date	Apr 8, 2020
Priority date	Mar 31, 2015
Publication date	Jun 7, 2022
Grant date	Jun 7, 2022

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 method for separating plasma from a whole blood sample, the method comprising:
(1) providing a multi-layer plasma separation card, wherein the multi-layer plasma separation card comprises:
(a) a first layer including a sample receiving member, wherein the sample receiving member is adapted to permit contact of the whole blood sample with a separating membrane, and wherein the sample receiving member comprises: (i) a top planar surface, wherein the top planar surface comprises an opening for applying or receiving a whole blood sample, and (ii) a bottom planar surface adapted to contact the separating member,
(b) a second layer including at least two separating members, wherein each separating member is adapted to permit the passage of plasma to an absorptive member, wherein each separating member is composed of a poly-sulfone material, and wherein each separating membrane comprises: (i) a top planar shield-shaped surface for receiving the blood sample; and (ii) a bottom planar shield-shaped surface adapted to contact the 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 the absorptive members, wherein each absorptive member is composed of a plasma collection fleece or material, or a plasma collection material that is not dissolvable in water or buffer containing solutions, wherein each absorptive member comprises a removable absorptive element having a planar surface-adapted to contact the bottom planar surface of the separating member, wherein the absorptive element is detachably fixed to the third layer;

(2) applying a whole blood sample onto the sample receiving member of the first layer; and
(3) allowing components of the whole blood sample to pass through the first layer, second layer, and third layer of the multi-layer plasma separation card, such that the plasma is separated from the other components of the whole blood sample and is absorbed onto the absorptive element of the third layer.

2. The method of claim 1 , wherein the at least two absorptive members are part of a strip, wherein the strip further comprises a non-absorptive handle adjacent to the absorptive element.

3. The method of claim 1 , wherein the at least two absorptive members comprise at least two elements for fixing the removable absorptive element with the third layer.

4. The method of 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.

5. The method of claim 1 , wherein the whole blood sample applied onto the sample receiving member of the first layer in step (2) has a volume of between 10 μl to 1000 μl.

6. The method of claim 1 , wherein the absorptive member comprises a fleece consisting of cotton linters with an average thickness of 300-420 μm.

7. The method of claim 1 , wherein the absorptive members have perforated borders.

8. The method of claim 5 , wherein the whole blood sample applied onto the sample receiving member of the first layer in step (2) has a volume of between 100 μl to 1000 μl.

9. The method of claim 1 , wherein steps (1)-(3) are performed over the course of 3-4 hours.

10. The method of claim 1 , further comprising the additional step of: (4) drying the multi-layer plasma separation card.

11. The method of claim 10 , wherein during steps (1)-(3), the multi-layer plasma separation card is allowed to dry over the course of 3-4 hours.

12. The method of claim 7 , wherein the absorptive members having perforated borders allow for easy removal and/or transferring of the absorptive elements to a vessel using tweezers.

Assignees

• Roche Molecular Systems Inc

Inventors

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

Classifications

• G01N33/491 Primary

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

• G01N33/525

  Multi-layer analytical elements · CPC title

• G01N2001/4088

  filtration · CPC title

• G01N1/405 Primary

  by adsorption or absorption · CPC title

• C12Q1/703

  Viruses associated with AIDS · CPC title