Stable liquid control serum or calibration system for use in clinical diagnostics

• US 5,281,536 A
• Filed: 10/22/1992
• Issued: 01/25/1994
• Est. Priority Date: 10/26/1991
• Status: Expired due to Term

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Wild, Thomas, Stegmueller, Peter
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Wallenhorst, Maureen M.
• Application Number:
  US07/964,755
• Time in Patent Office: 460 Days
• Field of Search: 436/8-19, 436/97, 436/176, 252/408.1
• US Class Current: 436/16
• CPC Class Codes: G01N 33/728 Bilirubin; including biliverdin
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• 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 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/146666 Bile pigment
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

A stable liquid control and/or calibration serum for use in clinical diagnostics containing a liquid-stable bilirubin derivative and a known concentration of at least one analyte. The invention further addresses a process for the preparation of the stable liquid serum.

Claims

1. Liquid composition useful as a control serum or a calibration serum, comprising:

(a) a serum sample containing a known concentration of at least one analyte, and

(b) a liquid stable bilirubin derivative of formula;

##STR2## wherein X stands for oxygen or sulfur

R stands for a C₁ -C₆ alkyl group which is mono- or polysubstituted with carboxy, alkoxy carbonyl, hydroxy, mercapto, amino, alkylamino, dialkylamino or alkylcarbonylamino and

Y stands for amino, alkylamino, dialkylamino, hydroxy, alkoxy groups, or the alkali salts thereof

wherein said composition does not contain bilirubin.

2. The liquid composition of claim 1, wherein said bilirubin derivative is bilirubin thioglycolic acid ether.

3. The liquid composition of claim 1, further comprising a preservative.

4. The liquid composition of claim 3, wherein said preservative is a bactericide.

5. The liquid composition of claim 4, wherein said bactericide is gentamycin.

6. The liquid composition of claim 3, wherein said preservative is a fungicide.

7. The liquid composition of claim 6, wherein said fungicide is 2,4-dichlorobenzyl alcohol.

8. The liquid composition of claim 1, further comprising a stabilizer.

9. The liquid composition of claim 8, wherein said stabilizer is ascorbic acid.

10. The liquid composition of claim 9, wherein said ascorbic acid is present at a concentration of from 0.5 to 1.5 mg/dl.

11. Reagent useful as a control serum or a calibration system comprising the liquid composition of claim 1 stored under a protective gas.

12. Reagent composition of claim 11, wherein said protective gas is N₂.

13. Reagent composition of claim 11, wherein said protective gas comprises a mixture of N₂ and CO₂.

14. The liquid composition of claim 1, having a pH of from 8.2 to 8.6.

15. The liquid composition of claim 1, further comprising creatine.

16. The liquid composition of claim 1, wherein said serum sample is bovine serum albumin.

17. The liquid composition of claim 1, further comprising EDTA.

18. The liquid composition of claim 1, further comprising a ferrous ion salt.

19. Process for improving storage stability of a control serum or calibration serum wherein said serum does not contain bilirubin, comprising adding to said control serum or calibration serum an amount of a compound of formula ##STR3## wherein X stands for oxygen or sulfur

R stands for a C₁ -C₆ alkyl group which is mono- or polysubstituted with carboxy, alkoxy carbonyl, hydroxy, mercapto, amino, alkylamino, dialkylamino or alkylcarbonylamino and

Y stands for amino, alkylamino, dialkylamino, hydroxy, alkoxy groups, or the alkali salts thereof

in an amount sufficient to stabilize said control serum or calibration serum.