Diagnostic compositions and devices utilizing same

• US 5,776,719 A
• Filed: 04/05/1996
• Issued: 07/07/1998
• Est. Priority Date: 07/07/1997
• 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:
  US08/628,794
• Time in Patent Office: 823 Days
• Field of Search: 435/28, 435/25, 435/14, 435/4, 435/18, 435/808, 435/287, 435/814, 435/970, 564/305, 564/250, 544/49, 585/400, 562/89, 562/493
• US Class Current: 435/28
• 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: G01N 33/523 the element being adapted for a specific analyte
• 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 dye indicator composition provides improved shelf life, stable color indication end point and capability for a system at near normal pH. The novel dry chemistry dye indication system comprises 3-Methyl-6-(sodium sulfonate)-benzothiazolinone-(2)-hydrazone (MBTH-S). A preferred dye systems are based on the dye couple (MBTH-S) and 8-anilino-1-naphthalenesulfonate (ANS), and the dye couple MBTH-S and N-(3-sulfopropyl)analine. These dye indicator systems are used in conventional blood chemistry test strips and are particularly preferred for indication of glucose in blood.

Claims

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

a support member,

a composition positioned on or impregnated in said support said composition comprising a composition for a dry chemistry reagent indicator comprising 3-Methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, wherein M is a positive charge ion providing a stable aqueous salt thereof, a second dye component selected from the group consisting of 3,3-dimethylaminobenzoic acid, 3,5-dichloro-2-hydroxybenzenesulfonic acid, 8-anilino-1-naphthalenesulfonate and N-(3-sulfopropyl)aniline and an oxidase enzyme or a peroxidase enzyme;

whereby the support member is adapted for receiving a fluid sample which contacts said composition and adapted for the support to provide for inspection or reading of the color change produced by said composition after contact with the fluid sample.

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

3. The device according to claim 1 wherein the second dye component is 8-anilino-1-naphthalenesulfonate.

4. The method according to claim 1 wherein the second dye component is N-(3-sulfopropyl)aniline.

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

applying a fluid sample to a support member having positioned thereon or impregnated therein a composition comprising a composition for a dry chemistry reagent indicator comprising 3-Methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, wherein M is a positive charge ion providing a stable aqueous salt thereof, a second dye component selected from the group consisting of 3,3-dimethylaminobenzoic acid, 3,5-dichloro-2-hydroxybenzenesulfonic acids 8-anilino-1-naphthalenesulfonate and N-(3-sulfopropyl)aniline and an oxidase enzyme or a peroxidase enzyme;

whereby the support member is adapted for receiving a fluid sample which contacts said composition and adapted for the support to provide for inspection or reading of the color change produced by said composition after contact with the fluid sample;

and

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

6. The method according to claim 5 wherein M is a sodium, postassium or ammonium ion.

7. The method according to claim 5 wherein the second dye component is 8-anilino-1-naphthalenesulfonate.

8. The method according to claim 5 wherein the second dye component is N-(3-sulfopropyl)aniline.