不同检测系统凝血四项结果的可比性验证

Comparability Verification of the Coagulation Tests in Different Measurement Systems

目的对同一实验室3台Stago凝血分析仪的凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(Fib)和凝血酶时间(TT)等4项凝血指标的结果进行可比性验证,并评价美国临床和实验室标准协会(CLSI)C54-A指南文件的实用性。方法参照C54-A文件,选择患者新鲜血浆作为比对样本,确定样本浓度(样本1和样本2)及重复检测次数,以室间质评允许总误差(TEa)的1/2作为PT、APTT和Fib比对结果的可接受标准(分别为7.5%、7.5%和10.0%),以实验室内部不精密度数据作为TT比对结果的可接受标准(4.6%),对3台凝血分析仪实施比对,计算比对偏差并分析结果可比性。结果样本1凝血四项检测结果的比对偏差分别为2.3%、6.8%、2.8%和1.8%,样本2的PT、APTT和Fib比对偏差分别为3.3%、4.0%和5.3%,均小于各自的可接受标准。结论 3台凝血分析仪凝血四项检测结果的可比性均通过验证。CLSI C54-A文件提供的比对方案简便直观易实施,结论较为可靠,可作为实验室内多个检测系统可比性验证的指南文件。

Objective To verify the comparability of test results of prothrombin time, activated partial thrombo plastine time, fibrinogen and thrombin time measured by three coagulation analyzers, and to discuss the practicality of the document CLSI C54 A. Methods The procedure of comparability testing was performed based on CI.SI C54 A, including selecting patient samples （Sample 1 and Sample 2）, determining concentrations and numbers of duplicate analyses. The critical difference of PT, APTT and Fib was intended to be 1/2TEa （7.5%, 7.5% and 10.0%, respectively） and 4.6% for TT based on internal imprecision data. Results The ranges of PT, APTT, Fib, and TT in Sample 1 were 2.3% 6.8%,2.8 % and 1.8 %; the PT,APTT and Fib in Sample 2 were 3.3%,4.0% and 5.3 % . respectively. Conclusion The comparability of the three coagulation analyzers was acceptable. The document C54 A provides an intuitive and simple approach for assessment of comparability of test results among quantitative measurement systems.