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Long-term stability of international reference preparations for thromboplastins
A M van den Besselaar1, J Hermans, H Beeser
1Department of Haematology, University Hospital, Leiden, The Netherlands.
British Journal of Haematology
|March 1, 1988
Summary
Certified reference thromboplastins show no signs of deterioration over time. Long-term stability monitoring by multiple labs is recommended to account for laboratory-specific variations.
Area of Science:
- Clinical Chemistry
- Biotechnology
- Medical Diagnostics
Background:
- Certified reference materials (CRMs) are crucial for standardizing thromboplastin reagents.
- Accurate calibration of thromboplastins is essential for effective oral anticoagulant therapy monitoring.
- The Community Bureau of Reference (BCR) provides CRMs for thromboplastin calibration.
Purpose of the Study:
- To assess the long-term stability of BCR-certified reference thromboplastins.
- To evaluate potential trends in prothrombin time (PT) and PT ratios over time.
- To determine if reference materials exhibit deterioration.
Main Methods:
- Monitoring of deep-frozen and lyophilized plasma samples over a five-year period (1981-1986).
- Measurement of prothrombin times and prothrombin time ratios on 19 separate occasions.
- Statistical analysis for time-dependent trends in PT and PT ratios.
Main Results:
- Significant trends in prothrombin time and prothrombin time ratio were observed (P < 0.05).
- No consistent pattern of trends across laboratories was identified.
- Observed trends are likely attributable to variations in local laboratory conditions, not material degradation.
Conclusions:
- The BCR-certified reference thromboplastins demonstrate stability and have not deteriorated.
- Variations in laboratory conditions can influence prothrombin time measurements.
- Simultaneous monitoring by at least two independent laboratories is recommended for robust stability assessment.
