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使用各种抗Xa测定法在临床实验室中体外测量低分子量肝素活性:实验室间变异性及对统一低分子量肝素标准品的要求

Measurement of low molecular weight heparin ex vivo activities in clinical laboratories using various anti-Xa assays: interlaboratory variability and requirement for an agreed low molecular weight heparin standard.

作者信息

Sié P, Aillaud M F, de Prost D, Droullé C, Forestier F, Guedj P, Juhan-Vague I, Polack B, Potron G, Roncato M

机构信息

Haemostasis laboratories, Hôpital Purpan, Toulouse, France.

出版信息

Thromb Haemost. 1987 Oct 28;58(3):879-83.

PMID:2829376
Abstract

The only sensitive and convenient assay to assess the biological activity of low molecular weight heparins (LMWHs) is based on the potentiation of activated factor Xa inhibition. Several procedures for measuring the socalled anti Xa activity have been proposed. In this collaborative study including eight laboratories, we have used four different assays (three amidolytic and one clotting based methods) for measuring the anti Xa activity of ex vivo samples obtained after injecting three different LMWHs. The dispersion of the results obtained by calibration against standard heparin could be reduced by using any of the three LMWHs for calibration. A coefficient of variation less than 0.20 between values obtained in different laboratories using a variety of methods seems acceptable. However it is necessary to refer to a common international standard for expressing the results in units and to define, for each of the three products, the therapeutic range.

摘要

评估低分子量肝素(LMWHs)生物活性的唯一灵敏且便捷的测定方法是基于对活化因子Xa抑制作用的增强。已提出了几种测量所谓抗Xa活性的方法。在这项包括八个实验室的协作研究中,我们使用了四种不同的测定方法(三种基于酰胺水解法和一种基于凝血法)来测量注射三种不同LMWHs后获得的离体样品的抗Xa活性。通过使用三种LMWHs中的任何一种进行校准,可以减少与标准肝素校准所得结果的离散度。使用多种方法在不同实验室获得的值之间的变异系数小于0.20似乎是可以接受的。然而,有必要参考一个通用的国际标准来以单位表示结果,并为这三种产品中的每一种定义治疗范围。

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