Test carrier for the analytical determination of a component of a liquid sample

• US 5,110,550 A
• Filed: 07/25/1989
• Issued: 05/05/1992
• Est. Priority Date: 07/30/1988
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Schlipfenbacher, Reiner, Steinbiss, Joachim
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Soderquist, Arlen
• Application Number:
  US07/384,726
• Time in Patent Office: 1,015 Days
• Field of Search: 422/55, 422/56, 422/57, 422/58, 422/59, 422/60, 435/805
• US Class Current: 422/423
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

A test carrier for the analytical determination of a component of a liquid sample, especially for the diagnosis of diseases, by means of a reaction sequence taking place on the test carrier with several test layers, which, in the initial state, are dry and, in the case of using the sample liquid, are wetted, comprising a base layer on which are present next to one another a sample application region and an evaluation region, a liquid transport path which extends from the sample application region into the evaluation region and a color-forming layer in which, on the basis of a color-formation reaction with the help of a color-forming reagent system, at least one color-forming reagent of which is present in the color-forming layer, there takes place an optically detectable change characteristic for the component to be determined. In the evaluation region above the surface of the color-forming layer facing away from the base layer, there is arranged an absorbent covering layer which, in the initial state of the test carrier, is so non-transparent that the color of the color-forming layer is not visible. The covering layer is in fluid contact with the liquid transport path and the covering layer and the color-forming layer are formed in such a manner that the color of the color-forming reagent becomes visible when both layers are wetted by the sample liquid.

Claims

1. Test carrier useful in determining a component of a liquid sample, comprising:

(a) a base layer having positioned thereon,

(i) a sample application region;

(ii) an evaluation region;

(b) a liquid transport path which extends from the sample application region into said evaluation region,

(c) a plurality of test layers, comprising a color forming layer positioned in the evaluation region of said liquid transport path, said color forming layer having a surface facing away from said base layer and containing at least one color forming reagent, and

(d) an absorbent covering layer positioned above said surface of the color forming layer facing away from said base layer, wherein said absorbent covering layer is in fluid contact with said liquid transport path, and said absorbent covering layer when wet permits visualization of color in said color forming layer but is non-transparent to, wherein the color forming layer and the absorbent covering layer are arraigned as the last section of the liquid transport path said color when dry.

2. Test carrier according to claim 1, wherein the absorbent layer consists of a material which is opaque in a dry state but is transparent in a moist state.

3. Test carrier according to claim 1, wherein the absorbent covering layer comprises a synthetic material membrane.

4. Test carrier according to claim 3, wherein the synthetic material membrane consists of polyvinylidene difluoride.

5. Test carrier according to claim 1, wherein the absorbent covering layer is less than 1 mm. thick.

6. Test carrier according to claim 5, wherein the absorbent covering layer is less than 0.3 mm. thick.

7. Test carrier according to claim 1, wherein the liquid transport path comprises a liquid transport layer which extends in one piece from the sample application region to over the whole color-forming layer simultaneously, forming the absorbent covering layer.

8. Test carrier of claim 1, further comprising (i) a mobile, labelled binding partner which specifically binds with the component to be detected or a substance which is indicative of said component, and (ii) a carrier bound binding partner which binds to any of said mobile labelled binding partner which does not bind to said component to be detected or said substance indicative of said component, wherein said mobile and carrier bound binding partners are positioned in said test carrier before said color forming layer.

9. Test carrier of claim 1, wherein said color forming reagent is dissolvably impregnated in said color forming layer.

10. Test carrier of claim 1, wherein said covering layer and said color forming layer comprise materials which permit spreading of said liquid sample in said covering layer before onset of reaction between said color forming reagent and a reactant transported thereto.

11. Test carrier of claim 1, further comprising a holding-down layer fixed on said base layer and having a liquid exchange surface region therebetween, whereby said color forming layer and covering layer are placed, pressed together, in said region.