Sysmex CS5100全自动凝血分析仪性能评价与比对研究

摘要

Objective To perform the performance evaluation of the Sysmex CS5100 automatic blood coagulation analyzer(CS5100) and to compare with the Sysmex CA7000 automatic blood coagulation analyzer(CA7000) for analyzing its accuracy and reliability.Methods The accuracy,precision,Fib linearity,carry-over contamination rate and biological reference interval of CS5100 were evaluated,meanwhile CS5100 and CA7000 were performed the comparative experiment.The detection indicators included plasma prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(Fib).Results The accuracy,intra-assay precision and inter-day precision of CS5100 for detecting the main parameters of PT,APTT,Fib,etc.conformed to the requirements of the ISO15189 related documents.The linearity of Fib was good(r=0.994),the maximum carry-over contamination rate was-2.81%.The reference interval accorded with 95% requirement.The achievement in participating in the external quality assessment was excellent.The results in comparison with CA7000 was qualified.Conclusion The various aspects of CS5100 performance is good and can be used in the detection of clinical specimens.The detection results can be used in clinical diagnosis and therapy.%目的 对Sysmex CS5100全自动凝血分析仪(以下简称CS5100)的性能进行评价,并与Sysmex CA7000全自动凝血分析仪(以下简称CA7000)比对,分析系统准确性及可靠性.方法 对CS5100进行正确度、精密度、纤维蛋白原(Fib)线性、携带污染率和参考区间进行评价,同时将CS5100与CA7000进行比对试验.检测指标包括凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、Fib.结果 CS5100检测PT、APTT、Fib等主要参数的准确性、批内不精密度、日间不精密度均符合ISO15189相关文件要求,Fib线性良好(r=0.994),最高携带污染率为-2.81%,参考区间符合95%的要求,参与室间质评成绩优秀,与CA7000比对结果合格.结论 CS5100各方面性能良好,可用于临床标本的检测,检测结果可用于临床的诊断和治疗.