两种血凝分析仪检测系统性能验证及结果比对

Comparison and evaluation of testing results for two different coagulation analyzers

目的 评价新投入使用的一台全自动血凝分析仪性能,并与临床上现用的凝血仪进行结果一致性的比较.方法根据审核标准对新投入使用的一台血凝分析仪进行精密度、线性、携带污染率、正确度评价;参照美国国家临床实验室标准化协会（NCCLS）的EP-5和EP-9文件,对新投入使用的血凝分析仪与临床正在使用并且性能稳定的血凝分析仪进行结果比对以及偏倚分析.结果 新投入使用的血凝分析仪的批内精密度（低值、中值、高值）在检测凝血酶原时间（PT）时分别为0.93%、1.32%、1.27%,活化部分凝血酶时间（APTT）为1.42%、0.84%、1.17%,纤维蛋白原（FIB）为1.82%、3.13%、3.19%,凝血酶时间（TT）为1.78%、1.76%、1.38%;FIB的实际检测值与理论值的线性回归方程为y=1.012x＋0.0219（P＞0.05）,截距与0之间差异无统计学意义（t=0.2287,P＞0.05）,直线斜率与1之间差异无统计学意义（t=0.3221,P＞0.05）,FIB线性回归方程与y=x直线方程差异无统计学意义;携带污染率为-2.33%;两台仪器PT、FIB的检测结果在医学决定水平处偏倚95%CI小于美国临床实验室修正法规1988（CLIA＇88）规定的可接受偏倚.结论 新投入使用的一台血凝分析仪性能符合仪器说明书的要求;两台血凝分析仪结果一致.

Objective To evaluate the performance of a newly installed fully automatic coagulation analyzer and compare the consistency of its testing results with the confirmed clinical automatic coagulation analyzer at our department MethodsPrecision,linearity,carryover and accuracy of the newly installed coagulation analyzer were evaluated according to the national required standards.Then the testing results were analyzed between the newly installed and confirmed coagulation analyzers according to the EP-5 and EP-9 documents of national committee for clinical laboratory standards（NCCLS）.Results For the newly installed coagulation analyzer,the low,median and high values of relative intra-precision were：0.93%,1.32% and 1.27% for prothrombin time（PT）;1.42%,0.84% and 1.17% for activated partial thromboplastin time（APTT）;1.82%,3.13% and 3.19% for fibrinogen（FIB）;1.78%,1.76% and 1.38% for thrombin time（TT）respectively.The linear regression equation of FIB actual and theoretical values was y=1.012x ＋ 0.0219（P〉0.05）.There was no significant statistical difference between the intercept and 0（t=0.2287,P〉0.05）and between linear slope and 1（t=0.3221,P〉0.05）.The carryover was-2.33%.The testing results of defined acceptable bias of PT and FIB in CLIA＇88 for two analyzers were within the acceptable 95%confidence interval of bias. ConclusionThe precision,linearity,carryover and accuracy of the newly installed coagulation analyzer meet the requirements of instrument user manual.The performance and the testing results of the same sample from two coagulation analyzers are consistent.