International collaborative study for the calibration of a proposed International Standard for thromboplastin, rabbit, plain
International collaborative study for the calibration of a proposed International Standard for thromboplastin, rabbit, plain
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DOI：
10.1111/j.1538-7836.2006.01910.x
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发表时间：
2006-06-01
影响因子：
10.4
通讯作者：
Tripodi, A.
中科院分区：
文献类型：
--
作者：
Chantarangkul, V.;Van den Besselaar, A. M. H. P.;Tripodi, A.
背景：一种暂编号为04/162的兔脑凝血活酶制剂被提议作为世界卫生组织（WHO）凝血活酶（普通兔源）国际标准（IS）的候选物，旨在替代编号为RBT/90（普通兔源）的国际标准，其库存现已耗尽。
结果：该制剂在一项涉及13个国家21个实验室的国际合作研究中进行了校准，校准是依据现有的世界卫生组织国际标准（即rTF/95和OBT/79）以及来自欧盟委员会标准物质与测量研究所（即CRM149 S）和欧洲抗凝行动（即EUTHR - 01）的其他有证标准物质进行的。另外一种编号为04/106的兔脑凝血活酶候选物也被纳入该研究。根据预先设定的标准（校准的实验室内和实验室间精密度以及对校准模型的符合性），04/162是首选候选物。
结论：所指定的国际敏感指数值为1.15，实验室间标准差和变异系数分别为0.057%和4.9%。
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 from 13 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.