Diagnostic compositions and devices utilizing same

• US 5,885,790 A
• Filed: 03/10/1998
• Issued: 03/23/1999
• 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:
  US09/037,653
• Time in Patent Office: 378 Days
• Field of Search: 435/28, 435/25, 435/4, 564/250
• 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 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 and/or a peroxidase enzyme.

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

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

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