Multi-center calibration of the third BCR reference material for thromboplastin, rabbit, plain, coded CRM 149S....

Area of Science:

• Biochemistry
• Clinical Chemistry
• Reference Materials

Background:

• Accurate thromboplastin calibration is crucial for reliable coagulation testing.
• The European Community Bureau of Reference (BCR) develops and validates reference materials for inter-laboratory consistency.
• Previous reference materials (CRM 149R, OBT/79) required long-term stability assessment.

Purpose of the Study:

• To calibrate a new rabbit plain thromboplastin reference material (CRM 149S) against the international standard (RBT/90).
• To assess the long-term stability of International Sensitivity Index (ISI) values for CRM 149S, CRM 149R, and OBT/79.
• To ensure the continued reliability and comparability of thromboplastin reference materials.

Main Methods:

• Collaborative study involving eleven laboratories.
• Calibration of CRM 149S against the World Health Organization (WHO) international reference preparation RBT/90.
• Inclusion of previous BCR reference materials (CRM 149R, OBT/79) for stability assessment.

Main Results:

• The new reference material CRM 149S achieved a mean International Sensitivity Index (ISI) of 1.257 (SE = 0.013).
• ISI values determined in this study showed near-identical relationships to historical values for all tested reference materials.
• The long-term stability of ISI values for rabbit and bovine thromboplastin reference materials was confirmed.

Conclusions:

• CRM 149S is a reliable reference material for rabbit thromboplastin, calibrated against the international standard.
• The established BCR reference materials demonstrate excellent long-term stability of their ISI values.
• These findings support the continued use and comparability of these essential diagnostic tools.