Sysmex CA-7000全自动血凝分析系统检测项目PT、APTT、FIB性能验证实验分析

Verification experimental analysis on test performance of PT,APTT and FIB via Sysmex CA-7000 Automatic Blood Coagulation Analysis System

目的验证Sysmex CA-7000全自动血凝分析系统对血浆凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)的分析性能。方法按照临床和实验室标准化研究院(CLSI)的标准和指南文件对Sysmex CA-7000全自动血凝分析仪检测PT、APTT、FIB的精密度、正确度、分析测量范围、生物参考区间及携带污染率进行了验证,并与质量目标要求和厂商声明的分析性能进行比较。结果批内精密度<1/4允许总误差(Tea)(CLIA,88),批间精密度<1/3Tea(CLIA’88),正确度试验结果满足1/2Tea(CLIA’88);分析测量范围项目FIB结果相关性好(r>0.975),线性理想(斜率接近于1);生物参考区间及携带污染率与厂商提供的相符合。结论 Sysmex CA-7000全自动血凝分析仪检测项目PT、APTT、FIB在精密度、正确度、生物参考区间、分析测量范围、携带污染率等5个方面满足质量目标要求和厂家声明的分析性能。

Objective To verify the analytic performance of plasma prothrombin time （ PT）, activated partial thromboplastin time （APTT） and fibrinogen （FIB） by Sysmex CA-7000 Automatic Blood Coagulation Analysis System. Methods According to the standards and the guidelines of the Clinical and Laboratory Standards Institute （CLSI） , we tried to verify the precision, trueness, analytical measurement range, biological reference interval and carry-over rates of PT, APTT and FIB, all of which were detected by Sysmex CA-7000 Automatic Blood Coagulation Analysis System. The results were compared with that of the quality target require-ments and the manufacturer statement analysis performance. Results The Intra-assay precisions were all less than 1/4 Tea （ CLIA＇ 88） , and the Inter-assay precisions were all less than 1/3 Tea （ CLIA＇ 88）. Trueness test results met 1/2 Tea （ CLIA＇ 88 ）. The analytical measurement range test in FIB was good （ r 〉 0. 975 ） , as well as the linearity （ slope was close to 1 ）. The bio-logical reference interval and the carry-over rate were consistent with what the manufacturer provided. Conclusion The outcomes of PT, APTT and FIB detected by Sysmex CA-7000 Automatic Blood Coagulation Analysis System meets the quality target require-ments and the manufacturer statement analysis performance in all the five aspects including precision, trueness, analytical measure-ment range, biological reference interval and carry-over rate.