TY - JOUR
T1 - International collaborative study for the calibration of a proposed international standard for thromboplastin, rabbit, plain
AU - Chantarangkul, V.
AU - Van Den Besselaar, A. M H P
AU - Witteveen, E.
AU - Tripodi, Armando
PY - 2006/6
Y1 - 2006/6
N2 - Background: A preparation of rabbit brain thromboplastin, provisionally coded 04/162, is proposed as a candidate for the World Health Organization (WHO) International Standard (IS) for thromboplastin (rabbit, plain), meant to replace the IS coded RBT/90 (rabbit, plain), stocks of which are now exhausted. Results: The preparation was calibrated in an international collaborative study involving 21 laboratories from13 countries and the calibration was performed against the existing WHO-IS (i.e. rTF/95 and OBT/79) and other Certified Reference Materials from the Institute for Reference Materials and Measurements of the European Commission (i.e.CRM149 S) and from the European Action on Anticoagulation (i.e. EUTHR-01). An additional candidate rabbit brain thromboplastin coded as 04/106 was also included in the study. On the basis of predefined criteria (the within- and between-laboratory precision of the calibration and the conformity to the calibration model), 04/162 was the preferred candidate. Conclusions: The assigned International Sensitivity Index value was 1.15 and the inter-laboratory SD and coefficient of variation were 0.057% and 4.9%, respectively.
AB - Background: A preparation of rabbit brain thromboplastin, provisionally coded 04/162, is proposed as a candidate for the World Health Organization (WHO) International Standard (IS) for thromboplastin (rabbit, plain), meant to replace the IS coded RBT/90 (rabbit, plain), stocks of which are now exhausted. Results: The preparation was calibrated in an international collaborative study involving 21 laboratories from13 countries and the calibration was performed against the existing WHO-IS (i.e. rTF/95 and OBT/79) and other Certified Reference Materials from the Institute for Reference Materials and Measurements of the European Commission (i.e.CRM149 S) and from the European Action on Anticoagulation (i.e. EUTHR-01). An additional candidate rabbit brain thromboplastin coded as 04/106 was also included in the study. On the basis of predefined criteria (the within- and between-laboratory precision of the calibration and the conformity to the calibration model), 04/162 was the preferred candidate. Conclusions: The assigned International Sensitivity Index value was 1.15 and the inter-laboratory SD and coefficient of variation were 0.057% and 4.9%, respectively.
KW - International Normalized Ratio
KW - International Sensitivity Index
KW - International Standard
KW - Oral anticoagulant treatment
KW - Thromboplastin
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U2 - 10.1111/j.1538-7836.2006.01910.x
DO - 10.1111/j.1538-7836.2006.01910.x
M3 - Article
C2 - 16706980
AN - SCOPUS:33646797021
VL - 4
SP - 1339
EP - 1345
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
SN - 1538-7933
IS - 6
ER -