Multi-layer test device for analyzing the concentration of analyte in a blood sample

• US 5,762,871 A
• Filed: 07/15/1997
• Issued: 06/09/1998
• 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, SUN U
• Application Number:
  US08/892,697
• Time in Patent Office: 329 Days
• Field of Search: 210/483, 210/488, 210/489, 210/490, 210/496, 210/503, 210/504, 210/505, 210/506, 210/508, 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: 422/401
• 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 multi-layer test device for analyzing the concentration of fructosamine in a whole blood sample, comprising:

(a) as a first layer, a blood separation layer, comprising;

(1) a polyester matrix impregnated with mannitol and hexadimethrine bromide; and

(2) a polysulfone membrane supporting said matrix;

(b) as a second layer, a liquid permeable buffer layer containing a buffer having a pH value of at least 9;

(c) as a third layer, an indicator layer containing an indicator capable of being reduced by fructosamine; and

(d) a support member optionally having a detection aperture;

wherein the blood separation layer is superposed above the buffer layer which is superposed above the indicator layer which is supported by said support member.

2. A multi-layer test device for analyzing the concentration of an analyte in a whole blood sample, comprising:

(a) a polyester matrix impregnated with mannitol and hexadimethrine bromide; and

(b) a nylon membrane supporting said matrix, said membrane containing at least one chemical reagent for analyzing the concentration of an analyte present in a whole blood sample.

3. The multi-layer test device of claim 2, wherein said analyte is glucose.