Standardisation of thrombin generation test - which reference plasma for TGT?: An international multicentre study
Standardisation of thrombin generation test - which reference plasma for TGT?: An international multicentre study
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DOI：
10.1016/j.thromres.2009.11.012
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发表时间：
2010-04-01
影响因子：
7.5
通讯作者：
Negrier, C.
中科院分区：
文献类型：
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作者：
Dargaud, Y.;Luddington, R.;Negrier, C.
我们以前已经表明，标准化和归一化的结果改善校准的自动凝血酶生成试验（TGT）的中心间变异性。我们怀疑参考血浆（RP）的来源可能是变异性的一个促成因素，并在一项国际多中心研究中比较了5种市售RP和NIBSC提供的RP。在里昂的Haemostasis Labotatory测定了6份供试血浆样品的详细组成。计算所有供试血浆的批间一致性、试验内、试验间变异性。RP和3份血浆样本（正常对照、低凝和高凝血浆）在5个欧洲中心进行了6天的检测。根据每个检测的RP对结果进行标准化，并比较结果的中心间变异性。所有实验室使用相同的试剂。标准化前，中心间变异性为19.8%至27.3%。标准化后，我们观察到一个显着改善实验室间的变化与所有测试的RP，尽管他们之间的差异。这些结果清楚地表明，通过使用参考血浆标准化可以显著降低TGT的中心间变异性，并且某些RP比其他RP具有更好的降低这种变异性的能力。(C)2009爱思唯尔有限公司保留所有权利。
We have previously shown that standardisation and normalization of results improve the intercentre variability of the calibrated automated thrombin generation test (TGT). We suspected that the source of reference plasma (RP) might be a contributing factor to variability and compared 5 commercial RP and a RP provided by the NIBSC, in an international, multicentre study. The detailed composition of the 6 tested plasma samples was determined in the Haemostasis Labotatory in Lyon. The lot to lot consistency, intra-assay, inter-assay variability were calculated for all tested plasmas. The RP and 3 plasma samples ( a normal control, a hypocoagulable and a hypercoagulable plasmas) were tested over 6 days, in 5 European centres. Results were normalised against each of the tested RP and intercentre variability of results was compared. All laboratories used the same reagents. Before normalization, the inter-centre variability was 19.8 to 27.3%. After normalization, we observed a significantly improved inter-laboratory variation with all tested RP, despite differences between them. These results clearly demonstrate that the inter-centre variability of TGT can be significantly reduced by using a reference plasma normalization, and that certain RP have a better capacity to reduce this variability than others. (C) 2009 Elsevier Ltd. All rights reserved.