Test device and method of determining concentration of a sample component

• US 4,772,561 A
• Filed: 12/23/1985
• Issued: 09/20/1988
• Est. Priority Date: 12/23/1985
• Status: Expired due to Fees

• Current Assignee: Miles, Inc. (Bayer AG)
• Original Assignee: Miles, Inc. (Bayer AG)
• Inventors: Genshaw, Marvin A.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US06/814,746
• Time in Patent Office: 1,002 Days
• Field of Search: 422/56, 422/58, 422/66, 436/169, 436/164, 436/166, 436/170, 356/306, 356/417
• US Class Current: 436/169
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The precision in reflectance or absorption measurements used to determine the presence and concentration of a component in an assay liquid is unexpectedly increased to essentially eliminate the variability of different reactant carriers and variability in reflectance or absorption instruments by including, either within the reactant carrier or within the assay liquid sample, in addition to a primary color forming or color changing indicator, a secondary inert colorant compound or dye having a light absorption wavelength peak separated from a light absorption wavelength peak of the primary indicator or chromogen by at least 80 nm. To achieve the full advantage of the present invention, the colorant material or marker should be inert to the reactant system in the carrier and should be inert to the assay liquid to provide a light reflectance or light absorption response essentially distinct from the light reflectance response of the primary chromogen to compensate for measurement variability. In this manner, any inaccuracy obtained from a reflectance or absorption measurement of the secondary colorant marker, incorporated into the carrier or into the assay sample in known concentration, can be used for compensation of a reflectance or absorption measurement of the primary color formed as a result of interaction or reaction of the test sample with the reagent composition, and, therefore, the concentration measurement of a predetermined component of the assay liquid.

Claims

1. A test article for detecting a relative concentration of a test compound in a test fluid comprising a liquid-absorbent or liqudi-adsorbent dry reagent carrier having homogeneously incorporated therein a regent composition capable of forming a primary color upon interaction with the test fluid to produce a change in the light reflectance of the carrier, and a secondary, inert colorant marker homogeneously incorporated into the carrier or the test fluid in a predetermined concentration, said colorant marker being inert to the test fluid and to the reagent composition and wherein the secondary, inert colorant marker has a light absorption wavelength peak different from a light absorption wavelength peak of the primary color by at lest 80 nm.

2. The test article of claim 1 wherein the reagent carrier comprises a bibulous material.

3. The test article of claim 1 wherein the secondary, inert colorant marker comprises a dye having a high absorption maximum peak separated by at least 120 nm from a light absorption maximum peak of the primary color formed by contact of the test article with a test sample.

4. A reagent strip for sensing the presence of a chemical compound in an assay liquid, comprising:

a dry carrier material capable of absorbing or adsorbing a liquid reactant composition for uniform distribution of the reactant compsition therein; and

a reactant composition uniformly distributed throughout the carrier;

said reactant composition including a compound capable of interaction with a predetermined component of the assay liquid to form a primary color in the reactant composition to produce a detectable change in the light reflectance of the carrier at a predetermined wavelength;

said reactant composition also including a secondary, inert colorant marker material having a light absorption wavelength peak different from the light absorption wavelength peak of the primary color by at least 80 nm.

5. The reagent strip of claim 4 wherein the reagent carrier comprises a liquid-absorbant or liquid-adsorbant bibulous material.

6. The reagent strip of claim 4 wherein inert colorant marker comprises a dye having a high absorption maximum peak separated by at least 120 nm from a light absorption maximum peak of the primary color.

7. In a dry test device for the quantitative measurement of a compound in a test liquid wherein the test device includes a reagent composition capable of interaction with the compound of the test liquid to produce a primary detectable color in the reagent composition after contact of the reagent composition with the test liquid, the improvement comprising a secondary colorant material inert to the test liquid and inert to the reagent composition homogeneously incorporated in the reagent composition or homogeneously incorporated in the test liquid in a known concentration and having a light absorption wavelength peak different form that of the primary formed color by at least 80 nm.

8. The test device of claim 7 wherein the reagent carrier comprises liquid-abosrbant or liquid-adsorbant bibulous material.

9. The test device of claim 7 wherein the secondary, inert colorant material comprises a dye having a high absorption maximum peak separated by at least 120 nm from a light absorption maximum peak of the primary color formed by contact of the test device with the test liquid.

10. A method of measuring the concentration of a predetermined chemical compound in an assay liquid comprising:

distributing a predetermined quantity of a reagent composition into a liquid-absorbent or liquid-adsorbent reagent carrier, wherein the reagent composition includes a compound capable of interaction with a predetermined componet of the assay liquid to cause a detectable change in the light reflectance of the carrier at a predetermined wavelength by formation of color or a color change in a primary chromogen;

said reactant composition also including a secondary, inert colorant marker material having a light absorption wavelength peak different from a light absorption wavelength peak of the primary chromogen by at least 80 nm;

drying the carrier;

contacting a surface of the dried carrier with the assay liquid to cause color changes detectable at wavelengths characteristic to both the primary chromogen and the secondary colorant in said carrier;

detecting the light refelctance of the carrier at a wavelength characteristic of the light reflectance of the primary chromogen, and detecting the light reflectance of the carrier at a wavelength characteristic of the light reflectance of the secondary, inert colorant marker material;

determining the concentration of said predetermined chemical compound based upon the degree of color change in the primary chromogen; and

correcting the concentration determination based upon the light reflectance measurement for the secondary chromogen.

11. The method of claim 10 wherein the reflectance measurements of the carrier are made at the absorption maximums for the primary chromogen and the secondary, inert colorant marker materials.

12. The method of claim 10 wherein the assay liquid is a biological fluid.

13. The method of claim 12 wherein the assay liquid is whole blood, serum, or plasma.

14. A method of measuring the concentration of a predetermined chemical compound in an assay liquid comprising:

distributing a predetermined quantity of a reagent composition into a reagent carrier, wherein the reagent compositon includes a compound capable of interaction with a predetermined component of the assay liquid to cause a detectable change in the light reflectance of the carrier at predetermined determined wavelength by formation of color or a color change in a primary chromogen;

said reactant composition also including a secondary, inert colorant marker material having a light absorption wavelength peak differnet from a light absorption wavelength peak of the primary chromogen by at least 80 nm;

drying the carrier;

contacting a surface of the dried carrier with the assay liquid to cause color changes detectable at wavelengths characteristic to both the primary chromogen and the secondary colorant in said carrier;

detecting the light reflectance of the carrier at a wavelength characteristic of the light reflectance of the primary chromogen, and detecting the light reflectance of the carrier at a wavelength characteristic of the light reflectance of the secondary, inert colorant marker material;

determining the concentration X of said predetermined chemical compound by the formula;

##EQU3## wherien the term ##EQU4## is representative of the degree of color change in the primary chromogen and the term ##EQU5## is the correction factor upon the light reflectance measurement for the secondary marker material, wherein X=analyte concentration of test sample;

L=analyte concentration of a low concentration calibrator solution;

H=analyte concentration of a high concentration calibrator solution;

K_X1 =K/S for sample at primary chromogen wavelength;

K_L1 =K/S for low calibrator at primary chromogen wavelength;

K_H1 =K/S for high calibrator at primary chromogen wavelength;

K_L2 =K/S for low calibrator at secondary chromogen wavelength;

K_H2 =K/S for high calibrator at secondary chromogen wavelength;

K_X2 =K/S for sample at secondary chromogen wavelength; and

##EQU6## wherein K is the absorption coefficient, S is the scattering coefficient, and R is the reflectance; and

correcting the concentration determination made for the predetermined chemical compound in accordance with said formula based upon the reflectance measurement for the secondary chromogen.