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Long-term stability of relationships between reference materials for thromboplastins
Thomas P J Linsinger1, Anton M H P van den Besselaar, Armando Tripodi
1EC-JRC, Institute for Reference Materials and Measurements, Geel, Belgium. thomas.linsinger@ec.europa.eu
Insights
Long-term stability of thromboplastin reference materials from the World Health Organization (WHO) and European Commission (EC) was monitored. Studies from 1994-2005 found no significant changes, ensuring reliable use in laboratory testing.
Area of Science:
- Biotechnology
- Clinical Chemistry
- Laboratory Medicine
Background:
- Reference materials are crucial for accurate laboratory testing.
- Ensuring the long-term stability of thromboplastin reference materials is essential for consistent results.
- The World Health Organization (WHO) and European Commission (EC) provide key thromboplastin reference materials.
Purpose of the Study:
- To monitor the long-term stability and relationship between European Commission (EC) and World Health Organization (WHO) thromboplastin reference materials.
- To assess potential time-dependent trends in the performance of rabbit thromboplastin reference materials.
- To evaluate the stability of rabbit thromboplastin reference material ERM-AD149 against bovine thromboplastin reference material OBT/79 over extended periods.
Main Methods:
- Monitoring the relationship between rabbit thromboplastin reference materials ERM-AD149 (EC) and RBT/90 (WHO) from 1996-2002.
- Conducting multicentre studies in 1994 and 2005 to determine the relationship between ERM-AD149 (rabbit) and OBT/79 (bovine) thromboplastin.
- Statistical analysis to detect significant trends or changes in the relationships between reference materials at a 5% significance level.
Main Results:
- No significant trend over time was detected in the relationship between ERM-AD149 and RBT/90 (rabbit thromboplastins).
- Multicentre studies in 1994 and 2005 showed no significant changes in the relationship between ERM-AD149 (rabbit) and OBT/79 (bovine) thromboplastins.
- The stability of these key thromboplastin reference materials was confirmed over the monitored periods.
Conclusions:
- The long-term stability of WHO and EC thromboplastin reference materials is confirmed.
- The established relationships between rabbit and bovine thromboplastin reference materials remained consistent over time.
- These findings support the continued reliable use of ERM-AD149, RBT/90, and OBT/79 in laboratory diagnostics.
Abstract:
Reference materials for thromboplastins are available from the World Health Organization (WHO) and the European Commission (EC). The long-term stability of the reference materials is an essential requirement and must be monitored. The relationship between two reference materials for rabbit thromboplastin, i.e. ERM-AD149 (EC) and RBT/90 (WHO), has been monitored in the period 1996-2002. No significant trend with time was detected. In addition, the relationship between ERM-AD149 and the reference material for bovine thromboplastin (i.e. OBT/79) has been determined in 1994 and in 2005 in multicentre studies (n = 11 and n = 9, respectively). No significant changes were observed in the relationships between these reference materials when all results were included (5% significance level).
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