应用NCCLS EP5-A2文件评价CA7000全自动血凝仪的精密度

Evaluation on precision of automatic coagulation analyzer CA7000 by using NCCLS EP5-A2 document

目的对CA7000全自动血凝仪进行精密度性能评价。方法按照NCCLSEP5-A2文件要求,对CA7000全自动血凝仪测定凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)4个项目的精密度进行评价。结果 CA7000全自动血凝仪测定PT、APTT、TT、FIB4个项目的批内精密度的变异系数为0.54%～1.51%、0.64%～1.61%、2.87%、1.68%;批间精密度变异系数为0.73%～3.27%、1.85%～2.06%、0%、1.98%;日间精密度变异系数为0.98%～1.82%、0.56%～1.55%、1.94%、1.61%;总精密度变异系数为2.40%～3.63%、2.11%～2.90%、3.31%、3.06%。结论 CA7000全自动血凝仪测定PT、APTT、TT、FIB的精密度能满足临床实验要求。

Objective To evaluate the precision of the automatic coagulation analyzer CA7000.Methods The precision of prothrombin time（PT）,activated partial thromboplastin time（APTT）,thrombin time（TT） and fibrinogen（FIB） examined by automatic coagulation analyzer CA7000 were evaluated by NCCLS EP5-A2 document.Results For the four items（PT,APTT,TT,FIB）,the within-run precision coefficients of variation were 0.54%-1.51%,0.64%-1.61%,2.87%,1.68%;the between-run precision coefficients of variation were 0.73%-3.27%,1.85%-2.06%,0%,1.98%;the between-day precision coefficients of variation were 0.98%-1.82%,0.56%-1.55%,1.94%,1.61%;the total precision coefficients of variation were 2.40%-3.63%,2.11%-2.90%,3.31%,3.06%.Conclusion The precision of PT,APTT,TT,FIB examined by automatic coagulation analyzer CA7000 can meet the requirements of clinical trials.