摘要
目的:对CA-7000全自动血凝分析仪分析系统检测项目D-二聚体(D-D)进行精密度性能评价。方法 :按照NCCLS EP5-A文件要求,对原装配套的CA-7000全自动血凝仪分析系统检测项目D-D批内不精密度(S批内)和总不精密度(S总)进行评价试验。结果:CA-7000全自动血凝仪分析系统测定D-D S批内和S总均小于厂商声明的不精密度(σ批内和σ总)性能指标。结论:CA-7000全自动血凝仪分析系统测定D-D精密度性能要求符合厂家声明的要求以及实验室的质量目标要求。
Objectiw To evaluate the D-dimer （D-D） detection precision of CA-7000 Automatic Coagulation Analyzer. Mothoda Based on NCCLS EP5-A document, the within-run imprecision and total imprecision of CA-7000 Automatic Coagulation Ana- lyzer were tested and evaluated, llatmlts The results of the within-run imprecision and total imprecision were less than the in- dexes provided by manufacturers claim. Conclusion The precision of D-D examined by CA-7000 Automatic Coagulation Ana- lyzer can meet the requirements of manufacturer and laboratory.
出处
《医疗卫生装备》
CAS
2014年第3期91-92,共2页
Chinese Medical Equipment Journal
