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血浆校准品在校正凝血仪对国际标准化比值影响方面的价值。一项国际多中心研究。

The value of plasma calibrants in correcting coagulometer effects on international normalized ratios. An international multicenter study.

作者信息

Poller L, Triplett D A, Hirsh J, Carroll J, Clarke K

机构信息

Department of Pathological Sciences, Medical School, University of Manchester, UK.

出版信息

Am J Clin Pathol. 1995 Mar;103(3):358-65. doi: 10.1093/ajcp/103.3.358.

Abstract

A study of lyophilized plasma calibrants in correcting for coagulometer effects on International Normalized Ratios (INR) has been conducted in an international survey. Prothrombin times were performed with the calibrants on 2 "common" thromboplastins and in-house thromboplastins in 3 brands of coagulometer at 37 centers. The International Sensitivity Indices (ISI) of 95 local systems with the calibrants were derived. The "true" INR of 10 test plasmas from warfarin-treated patients were established centrally using thromboplastin International Reference Preparations (IRP). International Normalized Ratios of these plasmas for each center were calculated using both the manufacturers' stated and the local ISI. The mean deviation of the 95 systems from the "true" INR of the warfarin plasmas was +14.4% with the manufacturers' ISI, but reduced to +1.04% with the local ISI. Local ISI determination with the calibrants avoids many of the difficulties of conventional thromboplastin calibrations. Plasmas from patients on warfarin and parallel manual PT with thromboplastin IRP are not required.

摘要

在一项国际调查中,对冻干血浆校准物在纠正凝血仪对国际标准化比值(INR)的影响方面进行了研究。在37个中心,使用校准物在3种品牌的凝血仪上对2种“常用”凝血活酶和自制凝血活酶进行了凝血酶原时间检测。得出了95个本地系统使用校准物后的国际敏感指数(ISI)。使用凝血活酶国际参考制剂(IRP)在中心实验室确定了10份来自华法林治疗患者的检测血浆的“真实”INR。每个中心使用制造商公布的ISI和本地ISI计算这些血浆的国际标准化比值。95个系统使用制造商的ISI时,与华法林血浆“真实”INR的平均偏差为+14.4%,但使用本地ISI时,该偏差降至+1.04%。使用校准物进行本地ISI测定避免了传统凝血活酶校准中的许多困难。无需使用来自华法林治疗患者的血浆以及与凝血活酶IRP平行的手工凝血酶原时间检测。

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