Analytical element containing a barrier zone and process employing same

• US 4,478,944 A
• Filed: 11/24/1982
• Issued: 10/23/1984
• Est. Priority Date: 11/24/1982
• Status: Expired due to Term

• Current Assignee: Clinical Diagnostic Systems Inc.
• Original Assignee: Eastman Kodak Company
• Inventors: Gross, Robert C., Gross, Susan C.
• Primary Examiner(s): Turk, Arnold
• Application Number:
  US06/444,112
• Time in Patent Office: 699 Days
• Field of Search: 436/169, 436/170, 436/95, 422/56, 422/57, 422/58, 435/805
• US Class Current: 436/95
• CPC Class Codes: C08J 2333/12 Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C08J 5/18 Manufacture of films or sheets
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A multizone element, for quantitative analyte determination in whole blood, containing a porous spreading zone separated from a reagent zone by a barrier zone, said barrier zone comprising a non-porous film comprising a polymer of: from 30 to 95 percent by weight of polymerized monomer having the structure ##STR1## from 0.25 to 30 percent by weight of polymerized monomer having the structure ##STR2## and from 0.1 to 50 percent by weight of polymerized monomer having the structure ##STR3## wherein: R¹, R³, and R⁵ are independently selected from the group consisting of hydrogen and methyl,

R² is alkyl of from 1 to 16 carbon atoms,

R⁴ and R⁶ are independently selected from the group consisting of alkylene groups having from 1 to 6 carbon atoms, ##STR4## wherein R⁷ is hydrogen, alkyl of 1 to 10 carbon atoms, or cycloalkyl of 5 to 10 carbon atoms, and

M is NR⁸ R⁹ H⁺ X or SO₃^- X wherein R⁸ and R⁹ are independently selected from the group consisting of hydrogen and alkyl of 1 to 4 carbon atoms and X is a counterion.

A process for employing the element in analyses for analytes in whole blood is also disclosed.

Claims

1. A multizone element, for quantitative analyte determination in whole blood, containing a porous spreading zone separated from a reagent zone by a barrier zone, said barrier zone comprising a non-porous film comprising a polymer of from 30 to 95 percent by weight polymerized monomer having the structure ##STR20## from 0.25 to 30 percent by weight polymerized monomer having the structure ##STR21## and from 0.1 to 50 percent by weight polymerized monomer having the structure ##STR22## wherein:

R¹, R³, and R⁵ are independently selected from the group consisting of hydrogen and methyl,

R² is alkyl of from 1 to 16 carbon atoms,

R⁴ and R⁶ are independently selected from the group consisting of alkylene groups having from 1 to 6 carbon atoms, ##STR23## wherein R⁷ is hydrogen, alkyl of 1 to 10 carbon atoms, or cycloalkyl of 5 to 10 carbon atoms, and

M is NR⁸ R⁹ H⁺ X or SO₃^- X wherein R⁸ and R⁹ are independently selected from the group consisting of hydrogen and alkyl of 1 to 4 carbon atoms and X is a counterion.

2. The element of claim 1 wherein the barrier zone further comprises up to 70% by weight of gelatin, based upon the combined weight of the polymer and the gelatin.

3. The element of claim 1 wherein the polymer further comprises up to about 20 percent by weight of a polymerized monomer containing an active methylene group in a side chain.

4. The element of claim 1 wherein the reagent zone includes a reagent for glucose.

5. The element of claims 1, 2, 3, or 4 wherein A is --O-- and R⁸ and R⁹ are both hydrogen.

6. The element of claims 1, 2, 3, or 4 wherein the polymerized monomer of the structure ##STR24## is selected from the group consisting of 2-methacryloyloxyethyl-1-sulfonic acid, sodium salt;

sodium 3-acryloyloxypropane sulfonate;

sodium 2-acrylamido-2-methylpropane sulfonate; and

2-aminoethyl methacrylate hydrochloride.

7. The element of claims 1, 2, 3, or 4 wherein the polymer is selected from the group consisting of poly(n-butyl methacrylate-co-2-methacryloyloxyethyl-1-sulfonic acid-co-2-acetoacetoxyethyl methacrylate-co-2-hydroxyethyl methacrylate);

poly(2-ethylhexyl methacrylate-co-methacryloyloxy-ethyl-1-sulfonic acid-co-2-acetoacetoxyethyl methacrylate-co-2-hydroxyethyl methacrylate); and

poly(n-butyl methacrylate-co-2-aminoethyl methacrylate hydrochloride-co-2-hydroxyethyl methacrylate).

8. A process, for quantitative analyte determination in whole blood, comprising bringing a sample of the blood into contact with a multizone element containing a porous spreading zone separated from a reagent zone by a barrier zone, said barrier zone comprising a non-porous film comprising a polymer of from 30 to 95 percent by weight polymerized monomer having the structure ##STR25## from 0.25 to 30 percent by weight polymerized monomer having the structure ##STR26## and from 0.1 to 50 percent by weight polymerized monomer having the structure ##STR27## wherein:

R¹, R³, and R⁵ are independently selected from the group consisting of hydrogen and methyl,

R² is alkyl of from 1 to 16 carbon atoms,

R⁴ and R⁶ are independently selected from the group consisting of alkylene groups having from 1 to 6 carbon atoms, ##STR28## wherein R⁷ is hydrogen, alkyl of 1 to 10 carbon atoms, or cycloalkyl of 5 to 10 carbon atoms, and

M is NR⁸ R⁹ H⁺ X or SO₃ ^- X wherein R⁸ and R⁹ are independently selected from the group consisting of hydrogen and alkyl of 1 to 4 carbon atoms and X is a counterion.

9. The process of claim 8 wherein the barrier zone further comprises up to 70% by weight of gelatin, based upon the combined weight of the polymer and the gelatin.

10. The process of claim 8 wherein the polymer further comprises up to about 20 percent by weight of a polymerized monomer containing an active methylene group in its side chain.

11. The process of claim 8 wherein the analyte being determined is glucose.

12. The process of claims 8, 9, 10, or 11 wherein A is --O-- and R⁸ and R⁹ are both hydrogen.

13. The process of claims 8, 9, 10, or 11 wherein the polymerized monomer of the structure ##STR29## is selected from the group consisting of 2-methacryloyloxyethyl-1-sulfonic acid, sodium salt;

sodium 3-acryloyloxypropane sulfonate;

sodium 2-acrylamido-2-methylpropane sulfonate; and

2-aminoethyl methacrylate hydrochloride.

14. The process of claims 8, 9, 10, or 11 wherein the polymer is selected from the group consisting of poly(n-butyl methacrylate-co-2-methacryloyloxyethyl-1-sulfonic acid-co-2-acetoacetoxy-ethyl methacrylate-co-2-hydroxyethyl methacrylate);

poly(2-ethylhexyl methacrylate-co-methacryloyloxy-ethyl-1-sulfonic acid-co-2-acetoacetoxyethyl methacrylate-co-2-hydroxyethyl methacrylate); and

poly(n-butyl methacrylate-co-2-aminoethyl methacrylate hydrochloride-co-2-hydroxyethyl methacrylate).