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A collaborative study to establish the 3rd International Standard for tissue plasminogen activator
Dawn Sands1, Colin M Whitton, R Elizabeth Merton
1Informatics Laboratory, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.
Thrombosis and Haemostasis
|August 28, 2002
Summary
A new international standard for tissue plasminogen activator (tPA) was established to replace the previous standard. Recombinant tPA (98/714) was selected as the 3rd International Standard for tPA.
Area of Science:
- Biochemistry
- Pharmacology
- Biotechnology
Background:
- The 2nd International Standard (IS) for tissue plasminogen activator (tPA) required replacement.
- International standards are crucial for ensuring consistency in tPA activity measurements.
Purpose of the Study:
- To establish a new International Standard for tissue plasminogen activator (tPA).
- To evaluate candidate materials for their suitability as the 3rd IS for tPA.
Main Methods:
- An international collaborative study involving 14 laboratories.
- Calibration of candidate standards against the 2nd IS for tPA (86/670).
- Assays performed using reference methods or laboratory-specific methods, with fibrin as a common promoter.
Main Results:
- Recombinant tPA (98/714) was identified as a suitable candidate material.
- The 3rd IS for tPA was established with a potency of 10,000 IU per ampoule.
- Both melanoma-derived and recombinant tPA are suitable for International Standards.
Conclusions:
- Recombinant tPA (98/714) was successfully established as the 3rd International Standard for tPA.
- The new standard was officially established by the WHO in November 2000.
- This ensures continued accurate quantification of tPA activity globally.