Diagnostic compositions and devices utilizing same

• US 5,989,845 A
• Filed: 09/10/1998
• Issued: 11/23/1999
• Est. Priority Date: 04/05/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Mercury Diagnostics, Inc.
• Inventors: Douglas, Joel S., Drexler, Karen R.
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/151,096
• Time in Patent Office: 439 Days
• Field of Search: 435/25, 435/28, 435/14, 435/4, 435/18, 435/808, 435/814, 435/970, 564/305, 564/250, 562/89, 562/493, 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 dry chemistry reagent matrix composition comprising a matrix material and a 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 imbibed and dried into or onto the matrix material.

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

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

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

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

6. The composition according to claim 1 wherein the oxidase enzyme is glucose oxidase.

7. The composition according to claim 1 wherein the matrix material is a polyethersulfone.

8. A device for testing a fluid for the presence or concentration of an analyte comprising:

a support member comprising a matrix material;

a dry chemistry reagent composition positioned on or impregnated in said support member, 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;

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.

9. The device according to claim 8 wherein M is a sodium, potassium or ammonium ion.

10. The device according to claim 8 wherein the dry chemistry reagent system 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.

11. The device according to claim 10 wherein the third dye component is 8-anilino-1-naphthalenesulfonate or a salt thereof.

12. The device according to claim 10 wherein the third dye component is N-(3-sulfopropyl)aniline or a salt thereof.

13. The device according to claim 8 wherein the oxidase enzyme is glucose oxidase.

14. The device according to claim 8 wherein the matrix material is a polyethersulfone.

15. A method of testing a fluid for the presence or concentration of an analyte comprising:

applying a fluid sample to a support member comprising a matrix material having positioned thereon or impregnated therein a dry chemistry 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;

whereby the support member is adapted for receiving a fluid sample which contacts said reagent 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; and

reading or measuring the color indication provided by said reagent composition after contact with said fluid sample.

16. The method according to claim 15 wherein M is a sodium, potassium or ammonium ion.

17. The method according to claim 15 wherein the dry chemistry reagent system 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.

18. The method according to claim 17 wherein the third dye component is 8-anilino-1-naphthalenesulfonate or a salt thereof.

19. The method according to claim 17 wherein the third dye component is N-(3-sulfopropyl)aniline or a salt thereof.

20. The method according to claim 15 wherein the oxidase enzyme is glucose oxidase.

21. The method according to claim 15 wherein the matrix material is a polyethersulfone.