Barrowcliffe T W, Curtis A D, Johnson E A, Thomas D P
National Institute for Biological Standards and Control, South Mimms, Herts., UK.
Thromb Haemost. 1988 Aug 30;60(1):1-7.
An international collaborative study has been carried out with the aim of establishing an international standard for low molecular weight (LMW) heparin. Three preparations of LMW heparin were assayed against the International Standard for unfractionated heparin (UFH) by 25 laboratories in 13 countries, using nine different assay methods. The results confirmed previous findings of non-parallel assays, wide interlaboratory variability and differences between methods when LMW heparins are assayed against a UFH standard. Use of one of the LMW heparins as a standard for the other two gave parallel assays and much closer agreement between laboratories. The preparation in ampoules coded 85/600 was selected as likely to give the best agreement with the largest number of LMW heparins; potencies were assigned by taking the mean of all the anti-Xa assays, and the mean of the thrombin and APTT assays, to represent the two major groups of activities. Preparation 85/600 has been established by WHO as the 1st International Standard for LMW heparin, with potencies of 1,680 iu/ampoule by anti-Xa assays and 665 iu/ampoule by thrombin inhibition and APTT assays.
为建立低分子量（LMW）肝素的国际标准开展了一项国际合作研究。13个国家的25个实验室使用9种不同的检测方法，针对普通肝素（UFH）国际标准对3种LMW肝素制剂进行了检测。结果证实了之前的研究发现，即当LMW肝素按照UFH标准进行检测时，存在检测不平行、实验室间差异大以及不同方法间存在差异的情况。将其中一种LMW肝素用作另外两种的标准进行检测时，检测呈现平行性，实验室间的一致性也更高。编码为85/600的安瓿装制剂被选为与最多数量的LMW肝素一致性最佳的制剂；通过采用所有抗Xa检测的平均值以及凝血酶和活化部分凝血活酶时间（APTT）检测的平均值来确定效价，以代表两种主要的活性组。85/600制剂已被世界卫生组织确立为第一国际LMW肝素标准，抗Xa检测的效价为1680 iu/安瓿，凝血酶抑制和APTT检测的效价为665 iu/安瓿。
