摘要
Abstract
[Objective]To evaluate the performance of the Antu AutoCimo C6000 fully automatic coagulation analyzer and compare it with Werfen to determine its application value.[Methods]The performance of the Antu AutoCimo C6000 fully automatic coagulation analyzer was evaluated in detecting coagulation function indicators in accordance with the requirements of medical laboratory quality and capability recognition criteria.The coagulation function indicators included prothrombin time(PT),activated partial thromboplastin time(APTT),thrombin time(TT),fibrinogen(FIB),D-dimer(D-D),fibrinogen degradation product(FDP),antithrombin Ⅲ(AT-Ⅲ),and the performance indicators included batch precision,daytime precision,accuracy,contamination rate(CR),linear range,clinically reportable range,and reference range.Then its evaluation results were compared with the results of the Werfen test.[Results]The test results of PT,APTT,TT,FIB,D-D,FDP,and AT-Ⅲ in batch precision CV and daytime precision CV at levels 1 and 2,and accuracy at levels 1 and 2,the test results of FIB CR and FIB on APTT CR,FIB,D-D,FDP,AT-Ⅲ linear range test results,the clinical reportable ranges of FIB,D-D,FDP,and AT-Ⅲ all met the judgment criteria.The actual reference ranges of PT,APTT,FIB,TT,D-D,FDP,and AT-Ⅲ were basically consistent with the reference range of the manual,and R values were all 1,which met the requirements.The PT,APTT,FIB,TT,D-D,FDP detection results of patient specimens analyzed by Antu AutoCimo C6000 fully automatic coagulation analyzer were highly consistent with the comparison results of the Werfen 750 type.[Conclusion]The performance of the Antu AutoCimo C6000 fully automatic coagulation analyzer meets the requirements and is highly consistent with the detection results of the Werfen 750 fully automatic coagulation analyzer.关键词
全自动凝血分析仪/性能/验证/沃芬Key words
fully automatic coagulation analyzer/performance/verification/Werfen分类
临床医学
