摘要
Abstract
Objective To conduct a comprehensive performance evaluation of fully automated coagulation analyzer in testing coagulation factors , protein S ( PS) , protein C ( PC) , anti-thrombin Ⅲ( AT-Ⅲ) , and von Willebrand factor antigen (vWF:Ag).Methods According to the Clinical and Laboratory Standards Institute (CLSI) EP5-A2, EP9-A2, and WS/T 406-2012 specifications, coagulation factors (FⅡ, FⅤ, FⅦ, FⅧ, FⅨ, FⅩ, FⅪ, and FⅫ) , PS, PC, AT-Ⅲ, and vWF:Ag were detected in the apparatus to evaluate the accu-racy , within-run and between-run imprecisions , linear range , carryover rate , method comparisons , and reference range of the ACL TOP 700 coagulation analyzer .Results The instrument had high accuracy and precision , a good linear range, and low carryover rate (0-2.63%, <3%).The biases of the 12 College of American Pa-thologists ( CAP) controls compared with the target value were all less than 15%, excepting the low value of PC . The within-run imprecisions of 8 coagulation factors were 1.7%-4.4%, and the between-run imprecisions were 2.2%-7.5%.The within-run imprecisions of 3 thrombophilia screen tests and vWF:Ag were 1.0%-7.0%and 2.2%-3.1%, and he between-run imprecisions were 1.5%-10.5% and 2.1%-4.1%, respectively . The carryover rates of the 12 items ranged from 0 to 2.63%.Results of liner verification test showed the correla-tion coefficients of PS , PC, AT-Ⅲ, and vWF:Ag were 0.982-0.988 .Results of method comprisons showed the correlation coefficients of ACL TOP 700 and other coagulation analyzer were more than 0.975 , and the recommen-ded reference ranges of all the 12 items were appropriate for our laboratory .Conclusions ACL TOP 700 coagu-lation analyzer has a good performance in accuracy , imprecision , carryover rate , linear range , and method com-parison .It is suitable for detection of clinical specimens .关键词
凝血分析仪/血栓与止血/性能Key words
coagulation analyzer/thrombosis and homeostasis/performance分类
医药卫生
