Control reagent for test strips for determining urobilinogen in urine

• US 4,298,498 A
• Filed: 12/13/1979
• Issued: 11/03/1981
• Est. Priority Date: 12/21/1978
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Rehner, Helmut, Rittersdorf, Walter
• Primary Examiner(s): Gron, Teddy S.
• Application Number:
  US06/103,025
• Time in Patent Office: 691 Days
• Field of Search: 260/326.2, 252/408, 23/230 B, 23/905, 23/930, 23/929, 23/901, 23/902, 23/913, 422/55, 422/56
• US Class Current: 436/8
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/146666 Bile pigment

Abstract

The present invention provides a control reagent for test strips for the detection of urobilinogen and possibly of other diagnostically relevant components, such as bilirubin, ketone bodies, glucose, protein, nitrite and blood, and possibly also of pH, which has a content of 2,4-dimethylpyrrole-3-carboxylic acid and/or of at least one alkali metal and/or alkaline earth metal salt thereof as control substance for urobilinogen.

Claims

1. An artificial human urine control reagent for analytical test strips used in analyzing human urine, comprising a mixture of a component selected from 2, 4-dimethylpyrrole-3-carboxylic acid, alkali metal salts thereof and alkaline earth metal salts thereof as a substitute for naturally occurring urobilinogen in human urine and at least one other component which is or simulates a diagnostically relevant component of human urine, the ratio of urobilinogen substitute to said other at least one component simulating conditions naturally occurring in human urine.

2. Control reagent as claimed in claim 1 wherein said 2,4-dimethylpyrrole-3-carboxylic acid component is 2,4-dimethylpyrrole-3-carboxylic acid.

3. Control reagent as claimed in claim 1 wherein said 2,4-dimethylpyrrole-3-carboxylic acid component is in solid form.

4. Control reagent as claimed in claim 1 wherein said 2,4-dimethylpyrrole-3-carboxylic acid component is in dissolved form.

5. Control reagent as claimed in claim 1 also comprising a buffer substance.

6. Control reagent as claimed in claim 1 wherein said test strip is for the detection of urobilinogen.

7. Control reagent as claimed in claim 6 wherein said test strip is for the detection of urobilinogen and, optionally, of other diagnostically relevant components.

8. Control reagent as claimed in claim 7 wherein such other diagnostically relevant components are bilirubin, ketone bodies, glucose, protein, nitrite, blood and pH.

9. Control reagent as claimed in claim 1 comprising

0.002 to 0.4 g. 2,4-dimethylpyrrole-3-carboxylic acid,

0 to 0.1 g. bilirubin salt,

0 to 5.0 g. aluminium acetylacetonate or an equivalent amount of the corresponding magnesium or beryllium compound,

0 to 0.1 g. nitrite,

0 to 7 g. albumin,

0 to 0.1 g. haemoglobin,

0.3 to 100 g. buffer substance, pH 7.5 to 9.0,

in solid or dissolved form, referred to 1 liter of solution.

10. Control reagent as claimed in claim 1 comprising

0.007 to 0.2 g. 2,4-dimethylpyrrole-3-carboxylic acid,

0 to 0.07 g. bilirubin salt,

0 to 2.0 g. aluminium acetylacetonate or an equivalent amount of the corresponding magnesium or beryllium salt,

0 to 0.01 g. nitrite,

0 to 3.0 g. albumin,

0 to 3.0 g. D(+)-glucose,

0 to 0.04 g. haemoglobin,

3 to 25 g. buffer substance, pH 7.8 to 6.5,

in solid or dissolved form, referred to 1 liter of solution.

11. Control reagent as claimed in claim 1 wherein the 2,4-dimethylpyrrole-3-carboxylic acid is used in the form of its sodium salt.

12. Control reagent as claimed in claim 5 wherein the buffer substance used has a buffer capacity of 5 to 25 mMol/liter.

13. Control reagent as claimed in claim 5 wherein the buffer substance used is sodium diethylbarbiturate/diethylbarbituric acid.

14. Control reagent as claimed in claim 1 in tablet form.