Test carrier for determining an analyte in whole blood

• US 5,536,470 A
• Filed: 07/06/1993
• Issued: 07/16/1996
• Est. Priority Date: 02/28/1991
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Frey, Gunter, Horn, Doris
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/078,268
• Time in Patent Office: 1,106 Days
• Field of Search: 422/56, 422/58, 422/61, 422/101, 436/63, 436/66-67, 436/164, 436/166, 436/169-170
• US Class Current: 422/427
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements

Abstract

Test carrier for the determination of an analyte from whole blood. Within a test field, it contains a reagent system. The test field has a sample application side to which the blood sample is fed, and a detection side on which, as a result of the analysis reaction, an optically detectable change occurs. It is designed so that the red blood corpuscles cannot gain access from the sample application side to the detection side, and it contains pigment particles for optical blockage of the red blood pigment.

Reliable separation in combination with simple manufacture is achieved in that the test field (5) has a combined blood pigment separation and detection layer (1) which, in a single, very thin homogeneous layer, fulfils the functions of separation of the red blood corpuscles and optical detection. It is formed from a dispersion or an emulsion of a polymeric film former which, in homogeneous distribution, contains the pigment, the polymeric film former, the color formation reagent of the reagent system and a swelling agent.

Claims

1. Test carrier for the determination of an analyte in whole blood using a reagent system having a colour formation reagent, said test carrier comprising:

a test field portion for receiving and reacting with a blood sample, said test field portion comprising a sample application side for receiving said blood sample, and a detection side opposite the sample application side for detecting an optically detectable change as a result of a reaction of the analyte with the reagent system,

the test field portion also comprising a film layer having a homogenous layer structure and which performs separation of erythrocytes and of the analyte blood pigment and performs a color formation for detection without needing to compensate for blood color, due to a portion of said blood sample appearing on said detection side being substantially free from blood pigment, said film layer being made from a film forming mass by evaporating a carrier liquid from a dispersion or emulsion of a polymeric film former, said dispersion or emulsion comprising, in homogeneous distribution, a pigment in a concentration of at least 30% by weight relative to the film-layer, the polymeric film former, the colour formation reagent, and a swelling agent, said pigment preventing the blood pigment from affecting the optically detectable change on the detection side of the test field portion,

wherein swelling properties of the swelling agent are selected such that the optically detectable change on the detection side is measurable after a maximum of one minute.

2. Test carrier according to claim 1, wherein a mean thickness of the film layer is no greater than 0.05 mm.

3. Test carrier according to claim 1, wherein the film layer is impregnated into an open-pore composite fibre structure wherein pores of the composite fibre structure are closed thereby.

4. Test carrier according to claim 3, wherein a mean pore size of the composite fibre structure is between 0.02 and 0.06 mm.

5. Test carrier according to claim 1, wherein the film layer is coated on to a microporous plastic layer.

6. Test carrier according to claim 5, wherein the microporous plastic film is disposed adjacent the sample application side of the test carrier.

7. Test carrier according to claim 5, wherein the microporous plastic film comprises an asymmetrical structure, and at least partially separates erythrocytes.

8. Test carrier according to claim 1, wherein the film layer is coated on to a plastic film.

9. Test carrier according to claim 1, wherein the swelling agent comprises a methyl vinyl ether maleic acid copolymer.

10. A test carrier according to claim 2, wherein said mean thickness is no greater than 0.025 mm.

11. A test carrier according to claim 2, wherein said mean thickness is no greater than 0.015 mm.

12. A test carrier according to claim 4, wherein the mean pore size of the composite fiber structure is between 0.03 and 0.05 mm.