Stago STA-R全自动血凝分析仪性能验证与评价

摘要

Objective To conduct the performance verification of the Stago STA-R automatic blood coagulation analysis system once every year to evaluate the analysis system for ensuring its accuracy and reliability .Methods According to the related docu-ments of the Clinical and Laboratory Standards Institute (CLSI) ,5 items of prothrombin time (PT ) ,activated partial clotting en-zyme live time (APTT) ,thrombin time (TT) ,fibrinogen (Fib) and antithrombin Ⅲ (ATⅢ) were selected to conduct the verifica-tion and preliminary evaluation on the accuracy ,imprecision ,carry-over rate ,linearity range and reference interval of the instrument analysis system .Results The relative bias(SE% ) of accuracy in each item was less than 5% .The intra-batch and inter-batch im-precisions (CV) were less than 3% and 5% respectively .The carry-over rates were within 4% .The linearity of Fib and AT Ⅲ was very well ,r2 were 0 .9980 and 0 .9979 respectively .Validated reference interval was consistent with quotative reference range . Conclusion The Stago STA-R automatic blood coagulation analysis system has good analytical performance ,can provide accurate and reliable test results for clinical doctors .%目的 该院每年对Stago STA-R全自动血凝仪进行一次性能验证,对分析系统进行评价,以确保仪器的准确可靠.方法 参照美国临床和实验室标准化协会相关文件,选择凝血酶原时间、活化部分凝血活酶时间、凝血酶时间、纤维蛋白原(Fib)、抗凝血酶Ⅲ(A TⅢ)5项对仪器分析系统的正确度、不精密度、携带污染率、线性范围、参考区间进行验证和初步评价.结果 各检测项目正确度相对偏倚(SE%)小于5%,批内和批间不精密度(CV)分别小于3%和5%,携带污染率小于4%;Fib、ATⅢ检测线性良好,r2分别为0.9980、0.9979;验证的参考区间与引用参考区间一致,参考个体符合引用参考区间的比率[R(%)]大于90%.各项验证全部符合相关标准,验证通过.结论 Stago STA-R全自动血凝仪具有良好的分析性能,能够为临床医生提供准确可靠的检测结果.