沃芬ACLTOP750全自动凝血分析仪凝血七项性能验证

Performance verification of Werfen ACLTOP750 automatic blood coagulation analyzer for seven blood coagulation tests

目的对沃芬ACLTOP750全自动凝血分析仪检验凝血七项进行性能验证。方法根据美国临床实验室标准化委员会(CLSI)EP文件、(CNAS)-GL037《临床化学定量检验程序性能验证指南》《临床血液学检验常规项目分析质量要求》(WS/T 406—2012)、《凝血分析仪》(YY/T 0659—2017)等文件,对PT、TT、APTT、FIB、FDP、DD、AT-Ⅲ7个项目的准确度、正确度、精密度、参考区间、携带污染率、线性范围、可报告范围性能进行验证。结果准确度、正确度、精密度结果均在允许范围内。所有项目参考区间验证通过。携带污染率均≤10%,符合要求。线性验证的回归方程斜率均在(1±0.05)内,且相关系数(r)均≥0.975,符合要求。可报告范围分析中0%≤R≤120%,验证通过。结论沃芬ACLTOP750全自动凝血分析仪性能验证符合质量目标要求,可用于临床标本的检验。

Objective This paper aims to verify the performance of Werfen ACLTOP750 fully automatic coagulation analyzer in detecting seven blood coagulation tests.Methods According to the EP document of Clinical Laboratory Standards Institute(CLSI),(CNAS)-GL037,WS/T406-2012 and YY/T0659-2017,the accuracy,trueness,precision,reference interval,carry over,linearity and reportable range of prothrombin time(PT),thrombin time(TT),activated partial thromboplastin time(APTT),fibrinogen(FIB),fibrinogen degradation product(FDP),D-dimer(DD)and antithrombin(AT-Ⅲ)were evaluated.Results The accuracies,trueness and precision were all within the allowable range.ACLTOP750 passed the reference interval verification in all items.The carry over rates were all≤10%,meeting the requirements.The slope of the linear regression equation of the actual and theoretical value was in the range of(1±0.05)and the correlation coefficient(r)≥0.975.The reportable range have been verified and meet the requirements(0%≤R≤120%).Conclusion Werfen ACLTOP750 automatic blood coagulation instrument is consistent with acceptable quality standards and can be used in clinical practices.