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用于新鲜血浆国际标准化比值(INR)测定的冻干校准血浆的现场研究。

Field study of lyophilized calibrant plasmas for fresh plasma INR determination.

作者信息

van den Besselaar A M H P, Houbouyan-Réveillard L L

机构信息

Haemostasis and Thrombosis Research Center, Department of Haematology, Leiden University Medical Center, The Netherlands.

出版信息

Thromb Haemost. 2002 Feb;87(2):277-81.

Abstract

An alternative approach to INR estimation is for laboratories to calibrate their own local system using calibrant plasmas supplied by manufacturers or reference laboratories. The purpose of the present study was to investigate the within-laboratory variability of a calibrant plasma procedure using various sets of lyophilized plasmas. INR had been assigned to 13 calibrant plasmas in a previous multi-center study. Each of 10 other ("field") laboratories measured PTs in the 13 calibrant plasmas and in 15 local fresh coumarin plasmas, using three different thromboplastin reagents. Each fresh coumarin PT was converted to INR using a calibration procedure with a set of 4 calibrants (1 normal + 3 abnormals). The abnormals of each set were either coumarin or artificial and were used with different assigned INR. When the INR had been assigned with a thromboplastin brand identical to the thromboplastin in the field laboratory, the procedure was named "reagent-specific" calibration. Otherwise the procedure was named "dissimilar" calibration. Using "reagent-specific" calibration procedures, relatively homogeneous INR were obtained for the fresh coumarin plasmas, whatever type of calibrant was used. In contrast, discrepant INR were obtained when "dissimilar" cross-species calibration procedures were used. The study was limited to 9 laboratories using the same type of coagulometer and one using a different type.

摘要

国际标准化比值(INR)估算的另一种方法是实验室使用制造商或参考实验室提供的校准血浆来校准其本地系统。本研究的目的是调查使用各种冻干血浆组的校准血浆程序在实验室内的变异性。在之前的一项多中心研究中,已为13种校准血浆指定了INR。其他10个(“现场”)实验室中的每一个都使用三种不同的凝血活酶试剂测量了13种校准血浆和15种本地新鲜香豆素血浆中的凝血酶原时间(PT)。使用一组4种校准物(1种正常 + 3种异常)的校准程序将每种新鲜香豆素PT转换为INR。每组中的异常校准物要么是香豆素要么是人工合成的,并且用于不同的指定INR。当使用与现场实验室中的凝血活酶品牌相同的凝血活酶指定INR时,该程序称为“试剂特异性”校准。否则,该程序称为“不同”校准。使用“试剂特异性”校准程序时,无论使用何种类型的校准物,新鲜香豆素血浆都能获得相对均匀的INR。相比之下,当使用“不同”的跨物种校准程序时,会获得不一致的INR。该研究仅限于9个使用相同类型凝血仪的实验室和1个使用不同类型凝血仪的实验室。

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