Diagnostic compositions and devices utilizing same

• US 6,379,915 B1
• Filed: 03/20/2000
• Issued: 04/30/2002
• 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., Drexler, Karen R.
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/528,655
• Time in Patent Office: 771 Days
• Field of Search: 435/28, 435/25, 435/14, 435/4, 435/808, 435/18, 435/814, 435/970, 435/283.1
• US Class Current: 435/28
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• 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 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; and

an oxidase enzyme or a peroxidase enzyme.

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

3. A composition according to claim 1 further comprising 8-anilino-1-naphthalenesulfonate.

4. A composition according to claim 1 further comprising N-(3-sulfopropyl)analine.

5. 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, and an oxidase enzyme or a peroxidase enzyme;

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

6. A device according to claim 5 wherein M is a sodium, potassium or ammonium ion.

7. A device according to claim 5 wherein the indicator further comprises 8-anilino-1-naphthalenesulfonate.

8. A device according to claim 5 wherein the indicator further comprises N-(3-sulfopropyl)analine.

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

a support member having positioned thereon or impregnated therein 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, and an oxidase enzyme or a peroxidase enzyme;

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

applying a fluid sample to said support member and contacting the fluid sample with said composition; and

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

10. A method according to claim 9 wherein M is a sodium, postassium or ammonium ion.

11. A method according to claim 9 wherein the indicator further comprises 8-anilino-1-naphthalenesulfonate.

12. A method according to claim 9 further comprising N-(3-sulfopropyl)analine.

13. A compound which is 3-Methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, wherein M is a positive charge ion providing a stable aqueous salt thereof.

14. A compound according to claim 13 wherein M is a sodium, potassium or ammonium ion.