Method, reagent and kit for the detection of fecal occult blood

• US 5,563,071 A
• Filed: 05/12/1995
• Issued: 10/08/1996
• Est. Priority Date: 09/14/1993
• Status: Expired due to Term

• Current Assignee: Propper Manufacturing Co. Inc.
• Original Assignee: Propper Manufacturing Co. Inc.
• Inventors: Augurt, Thomas A.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US08/439,603
• Time in Patent Office: 515 Days
• Field of Search: 422/56, 422/57, 422/58, 422/61, 436/66, 436/8, 436/19, 436/164, 436/169, 436/904, 435/28, 435/805, 435/810
• US Class Current: 436/66
• CPC Class Codes: C12Q 1/28 involving peroxidase
• CPC Class Codes: G01N 33/725 using peroxidative activity
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/904 Oxidation - reduction indicators
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A fecal specimen may be tested for the presence of occult blood by combining the fecal specimen with

(a) an oxidizable substrate that produces a colored product in the presence of peroxide and hemoglobin;

(b) hydrogen peroxide or a peroxide source; and

(c) an enhancer selected to enhance the sensitivity of the test. Suitable enhancers are monocyclic nitrogen-containing aromatic heterocyclic compounds; tertiary or quaternary ammonium compounds having a phenyl, hydroxy alkyl or esterified hydroxy alkyl attached to the nitrogen; or quinoline or a substituted derivative thereof. If hemoglobin is present in the fecal sample, the oxidizable substrate is converted to the visibly detectable, colored product.

Claims

1. A method for detecting occult blood in a specimen comprising combining the specimen with

(a) an oxidizable substrate that produces a colored product in the presence of peroxide and hemoglobin;

and

(b) a liquid developer comprising hydrogen peroxide or a peroxide source, a carrier consisting essentially of water and ethanol, and an enhancer component, said enhancer component consisting of a material selected from the group consisting of tertiary and quaternary amines having a hydroxy alkyl or esterified hydroxy alkyl group attached to the nitrogen, wherein the oxidizable substrate and liquid developer are combined with the specimen in amounts effective to produce a visually detectable color change if medically significant amounts of blood are present in the specimen.

2. A method according to claim 1, wherein the enhancer component is present in the carrier in amounts of from 0.2% to 4% by weight.

3. A method according to claim 1, wherein the enhancer component is present in the carrier in amounts of from 0.3% to 1.5% by weight.

4. A method according to claim 1, wherein the enhancer component is phenyl diethanolamine.

5. A method according to claim 1 wherein the enhancer component is dimethyl ethanolamine.

6. A composition for use as a developer in a test for occult blood based upon the oxidation of a substrate to a colored product comprising

(a) hydrogen peroxide or a peroxide source;

(b) an amount of an enhancer component effective to enhance the amount of colored product produced; and

(c) a carrier consisting essentially of water and ethanol, wherein the enhancer component consists of a material selected from the group consisting of tertiary and quaternary amines having a hydroxy alkyl or esterified hydroxy alkyl group attached to the nitrogen.

7. A composition according to claim 6, wherein the enhancer component is present in amounts of from 0.2% to 4% by weight.

8. A composition according to claim 7, wherein the peroxide is present in an amount of from 4% to 6% by weight.

9. A composition according to claim 6, wherein the peroxide is present in an amount of from 4% to 6% by weight.

10. A composition according to claim 6, wherein the enhancer component is phenyl diethanolamine.

11. A composition according to claim 6, wherein the enhancer component is dimethyl ethanolamine.

12. A kit for the detection of occult blood comprising, in packaged combination,

(a) an oxidizable substrate which is converted to a colored product in the presence of peroxide and hemoglobin;

and

(b) a liquid developer comprising hydrogen peroxide or a peroxide source and an enhancer component in an amount effective to enhance the conversion of the oxidizable substrate to the colored product in a carrier consisting essentially of ethanol and water, wherein the enhancer component consists of a material selected from the group consisting of tertiary and quaternary amines having a hydroxy alkyl or esterified hydroxy alkyl group attached to the nitrogen.

13. A kit according to claim 12, wherein the enhancer component is present in the developer in an amount of from 0.2% to 4% by weight.

14. A kit according to claim 13, wherein the peroxide is present in the developer in an amount of from 4% to 6% by weight.

15. A kit according to claim 12, wherein the peroxide is present in the developer in an amount of from 4% to 6% by weight.

16. A kit according to claim 12, wherein the enhancer component is phenyl diethanolamine.

17. A kit according to claim 12, wherein the enhancer component is dimethyl ethanolamine.