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运用NCCLSEP5-A评价CA-7000全自动血凝仪D-二聚体检测的精密度
引用本文:王秋菊,王兴祖,肖辉建,等.运用NCCLSEP5-A评价CA-7000全自动血凝仪D-二聚体检测的精密度[J].医疗卫生装备,2014(3):91-92.
作者姓名:王秋菊  王兴祖  肖辉建  
作者单位:解放军180医院检验科,福建泉州362000
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NCCLSEP5-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(S4)进行评价试验。结果:CA-7000全自动血凝仪分析系统测定D—DS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。

关 键 词:精密度  D-二聚体  EP5-A

NCCLS EP5 A-based Evaluation of D-dimer Detection Precision of CA-7000 Automatic Coagulation Analyzer
WANG Qiu-ju,WANG Xing-zu,XIAO Hui-jian,ZHAO Gui-mei,LING Yue-ming.NCCLS EP5 A-based Evaluation of D-dimer Detection Precision of CA-7000 Automatic Coagulation Analyzer[J].Chinese Medical Equipment Journal,2014(3):91-92.
Authors:WANG Qiu-ju  WANG Xing-zu  XIAO Hui-jian  ZHAO Gui-mei  LING Yue-ming
Institution:(Department of Clinical Laboratory, the 180th Hospital of the PLA, Quanzhou 362000, Fujian Province, China)
Abstract: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.
Keywords:precision  D-Dimer (D-D)  EPS-A
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