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International collaborative study to establish the 3rd International Standard for Streptokinase
D Sands1, C M Whitton, C Longstaff
1Informatics Division, National Institute for Biological Standards and Control, Potters Bar, UK.
Journal of Thrombosis and Haemostasis : JTH
|August 12, 2004
Summary
A new international standard for Streptokinase was established using candidate preparations. The study confirmed that a solution chromogenic assay is a reliable method for determining Streptokinase potency.
Area of Science:
- Biochemistry
- Pharmacology
- Clinical Chemistry
Background:
- The 2nd International Standard (IS) for Streptokinase is nearing depletion, necessitating the establishment of a replacement standard.
- An international collaborative study was conducted to calibrate new candidate preparations for the Streptokinase IS.
Purpose of the Study:
- To calibrate and validate a replacement for the 2nd International Standard (IS) for Streptokinase.
- To assess the suitability of candidate preparations and different assay methods for establishing the 3rd IS for Streptokinase.
Main Methods:
- Sixteen laboratories in 12 countries participated, assaying two candidate preparations (88/824 and 00/464) against the 2nd IS.
- Laboratories employed a fibrin clot lysis assay, a solution chromogenic method, or in-house methods for potency determination.
- Inter-laboratory and inter-method comparisons were performed to evaluate assay agreement and reliability.
Main Results:
- Good agreement was observed within and between laboratories, with no significant differences in potency across the methods used, except for one outlying laboratory.
- The study demonstrated that a solution chromogenic assay is an acceptable and effective method for determining Streptokinase potency, without the need for fibrin.
- Preparation 00/464 was approved as the 3rd International Standard (IS) for Streptokinase with a potency of 1030 IU per ampoule.
Conclusions:
- A solution chromogenic plasminogen activation assay is suitable for Streptokinase potency determination and will replace the current euglobulin reference method in the European Pharmacopoeia.
- Preparation 00/464 has been established as the 3rd International Standard for Streptokinase, ensuring continued availability of this crucial standard.
- The collaborative study successfully validated a new standard and assay method, strengthening the quality control of Streptokinase preparations.