Barrowcliffe T W, Curtis A D, Tomlinson T P, Hubbard A R, Johnson E A, Thomas D P
Thromb Haemost. 1985 Oct 30;54(3):675-9.
A collaborative study was carried out, in which eight laboratories each assayed eight low molecular weight (LMW) heparins against the International Standard (IS) for heparin. APTT assays and three types of anti-Xa method were used. The results of this study showed that: LMW heparins cannot be validly assayed against the IS by APTT or anti-Xa methods. Potencies of LMW heparins vs. the IS differed considerably between the four types of assay method used and also between different laboratories using the same type of method. Adoption of a single LMW heparin standard would improve validity, improve inter-laboratory variation, and largely abolish the differences between the three types of anti-Xa method. However, since calibration of a LMW heparin standard against the IS would give potencies that differ widely by the different assay methods, a single assay method such as the anti-Xa amidolytic, plasma, would need to be chosen for this calibration.
开展了一项合作研究，八个实验室各自针对肝素国际标准品（IS）对八种低分子量（LMW）肝素进行了测定。采用了活化部分凝血活酶时间（APTT）测定法和三种抗Xa方法。该研究结果表明：无法通过APTT或抗Xa方法有效地针对IS对LMW肝素进行测定。在使用的四种测定方法之间以及使用同一类型方法的不同实验室之间，LMW肝素相对于IS的效价差异很大。采用单一的LMW肝素标准品将提高有效性，改善实验室间差异，并在很大程度上消除三种抗Xa方法之间的差异。然而，由于针对IS校准LMW肝素标准品会得出因不同测定方法而有很大差异的效价，因此需要选择单一的测定方法（如抗Xa酰胺水解血浆法）进行此校准。
