Plasma separation card

Patent metadata

Field	Value
Publication number	US-2016290901-A1
Application number	US-201615085882-A
Country	US
Kind code	A1
Filing date	Mar 30, 2016
Priority date	Mar 31, 2015
Publication date	Oct 6, 2016
Grant date	—

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-sharped 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

1 . 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-sharped 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.

2 . The multi-layer plasma separation card according to claim 1 , wherein said absorptive element is part of a strip, wherein said 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 comprising 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 being either directly in contact with or 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 on each of the sample receiving portions 10 μl to 1000 μl of a whole blood sample is applied.

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 method for preparing a multi-layer plasma separation card according to claim 1 , comprising the following steps (1) preparing a separation member layer, an absorptive member layer comprising a plasma separation fleece, a spotting layer and an adhesive layer, (2) combining the layers prepared by sticking the spotting layer onto the adhesive layer in a suitable device wherein the separation membrane layer is inserted and grouted with the side of the adhesive layer not stuck to the spotting layer and subsequently putting the absorptive membrane layer onto the separation membrane layer and (3) sticking the composite of the layers onto a carrier support layer in longitudinal direction.

13 . A method for detecting HIV, HCV and/or HBV in a plasma sample comprising using the multi-layer plasma separation card according to claim 1 .

14 . A packaging concept comprising a multi-layer plasma separation card according to claim 1 and a desiccant material in a hermetically sealed environment.

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

• G01N33/491 Primary

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

• C12Q1/703

  Viruses associated with AIDS · CPC title

• G01N2001/4088

  filtration · CPC title

• G01N33/525

  Multi-layer analytical elements · CPC title