一台血凝分析仪维修后的性能验证

目的 对维修后的血凝分析仪进行性能验证.方法 按照美国临床和实验室标准协会颁布的EP5-A2和EP6-A2文件对维修后的血凝分析仪进行精密度、线性及携带污染率进行验证.结果 按正常(N)和异常(P)两个浓度,批内精密度:分别为PT(0.95％和0.65％)、APTT(0.57％和0.62％)、FIB(0.66％和1.08％),总精密度:依次为PT(1.60％和2.04％)、APTT(2.12％和2.06％)、FIB(3.20％和3.42％);TT正常浓度的批内精密度和总精密度分别为0.96％和2.73％.FIB的线性回归方程为y=1.029 2x-0.154 8,r2=0.999 9,FIB携带污染率为6.50％.结论 维修后,血凝分析仪精密度、线性范围及携带污染率均符合临床实验室要求.

Performance evaluation of one coagulation analyzer after maintenance

Objective To evaluate the performance of one coagulation analyzer after maintenance.Methods The precision,linearity,and carry over were verified in turn according to EP5A2 and EP6-A2 of clinical and laboratory standards institute(CLSI).Results For the maintained coagulation analyzer,the normal and pathological values of relative intra-precision were 0.95％ and 0.65％ for prothrombin time (PT),0.57％ and 0.62％ for activated partial thromboplastin time (APTT),and 0.66％ and 1.08％ for fibrinogen(FIB),respectively.The normal and pathological values of relative total precision were 1.6％ and 2.04％ for prothrombin time (PT),2.12％ and 2.06％ for activated partial thromboplastin time(APTT),and 3.2％ and 3.42 ％ for fibrinogen(FIB),respectively.The intra-precision and total precision values on the normal value of thrombin time (TT) were 0.96％ and 2.73％.The linear regression equation of FIB was y=1.029x-0.1548,r2=0.9999.The carry over was 6.5％.Conclusions The precision,linearity,and carry over of the maintained coagulation analyzer meet the performance requirements of clinical laboratory.