Diagnostic compositions and devices utilizing same

• US 6,242,207 B1
• Filed: 10/04/1999
• Issued: 06/05/2001
• Est. Priority Date: 04/05/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Douglas, Joel S., Priest, John H., Drexler, Karen R., Gleisner, John M.
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/411,237
• Time in Patent Office: 610 Days
• Field of Search: 435/25, 435/28, 435/14, 435/808, 435/814, 435/970, 564/305, 564/250, 564/89, 564/493, 544/49
• US Class Current: 435/25
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: C12Q 2326/00 Chromogens for determinations of oxidoreductase enzymes
• CPC Class Codes: C12Q 2326/32 3-Methyl-2-benzothiazolinone hydrazone hydrochloride hydrate, i.e. MBTH
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/814 Enzyme separation or purification
• CPC Class Codes: Y10S 435/97 Test strip or test slide

Abstract

A dry chemistry reagent matrix composition is provided containing a matrix material and a reagent composition containing 3-methyl-6(sulfonate salt)-benzothiazolinone-(2)-hydrazone (MBTH-S), N-ethyl-N-(3-sulfopropyl)aniline, and an oxidase enzyme or a peroxidase enzyme or a mixture thereof. The dry chemistry reagent matrix composition is useful in reagent test strips for determining the presence or concentration of an analyte in a fluid sample, such as blood.

Claims

1. A method of making a device for testing a fluid for the presence or concentration of an analyte comprising applying a chemistry reagent composition to a support member comprising a matrix material said reagent composition comprising 3-methyl-6(M sulfonate)-benzothiazolinone-(2)-hydrazone (MBTH-S) where M is a positive ion providing a stable sulfonate salt;

N-ethyl-N-(3-sulfopropyl)aniline or a salt thereof; and

an oxidase enzyme or a peroxidase enzyme or a mixture thereof, wherein the reagent composition is immobilized into or onto the matrix material and drying the reagent composition whereby the support member is adapted for receiving a fluid sample which contacts said composition and adapted for the support member to provide for inspection or reading of the color change produced by said reagent composition after contact with the fluid sample.

2. A method according to claim 1 wherein M is a sodium, potassium or ammonium ion.

3. A method according to claim 1 further comprising a third dye component selected from the group consisting of 3,3-dimethylaminobenzoic acid, 3,5-dichloro-2-hydroxybenzenesulfonic acid, 8-anilino-1-naphthelenesulfonate, N-(3-sulfopropyl)aniline or salts thereof.

4. A method according to claim 3 wherein the third dye component is 8-anilino-1-naphthalenesulfonate or a salt thereof.

5. A method according to claim 3 wherein the third dye component is N-(3-sulfopropyl)aniline or a salt thereof.

6. A method according to claim 1 wherein the oxidase enzyme is glucose oxidase.

7. A method according to claim 1 wherein the matrix material is a polyethersulfone.

8. A method according to claim 1 wherein the matrix material comprises a support member adapted for receiving a fluid sample which contacts said composition and adapted to provide for inspection or reading of the color change produced by said reagent composition after contact with the fluid sample.

9. A method according to claim 1 wherein the chemistry reagent composition further comprises a third dye component selected from the group consisting of 3,3-dimethylaminobenzoic acid, 3,5-dichloro-2-hydroxybenzenesulfonic acid, 8-anilino-1-naphthelenesulfonate, N-(3-sulfopropyl)aniline or salts thereof.

10. A method according to claim 9 wherein the third dye component is 8-anilino-1-naphthalenesulfonate or a salt thereof.

11. A method according to claim 9 wherein the third dye component is N-(3-sulfopropyl)aniline or a salt thereof.

12. A method according to claim 1 wherein the oxidase enzyme is glucose oxidase.

13. A method according to claim 1 wherein the matrix material is a polyethersulfone.