摘要
目的 以中心实验室贝克曼检测系统(Beckman Access Ⅱ化学发光法)为对照,横向对比分析瑞莱(RELIA TZ302免疫荧光法)、美艾利尔(Alere Triage MeterPro微流控法)、微点(Micropoint mLabs荧光微流控法)三家企业在心肌肌钙蛋白Ⅰ项目上的诊断试剂检测能力。方法 对2016年4月4日至8日于上海市第十人民医院的79例心肌肌钙蛋白T阳性样本进行四种检测系统的心肌肌钙蛋白Ⅰ检测,比较四种方法的检测结果。结果 四种检测系统不精密度均达到临床要求(CV<20%),贝克曼、瑞莱、微点的检测范围、线性(R>0.99)、灵敏度均较好,美艾利尔的检测范围较小(0.01~10ng/mL)。瑞莱与贝克曼相关性较好(R=0.944),美艾利尔在其检测范围内与贝克曼相关性也较好(R=0.931),微点与贝克曼相关性较差(R=0.846),三家检测试剂与贝克曼一致性均良好(超出LOA 95%CI的检测值小于5%)。结论 本实验对比分析了三种体外诊断试剂方法与医疗单位常见中心实验室方法的检测能力,展现了三种体外诊断试剂的检测性能,为医院、胸痛中心、街道乡镇卫生服务中心等机构或实验室选择合适的体外诊断试剂给出理论依据和指导。
Objectives With Beckman detection system(Beckman Access II chemiluminescence method)in the central laboratory as the control,the detection ability of diagnostic reagents inRELIA(TZ302 immunofluorescence method),Alere(Triage MeterPro microfluidic method)and Micropoint(mLabs fluorescent microfluidic method)in cardiac troponin I(cTnI)project was compared and analyzed horizontally.Methods A total of 79 cases of cardiac troponin T positive samples from Shanghai Tenth People’s Hospital from April 4 th to 8 th,2016were tested for cardiac troponin I using four detection systems,and the results of the four methods were compared.Results The imprecision of the four detection systems met the clinical requirements(CV<20%).The detection range,linearity(R>0.99),and sensitivity of Beckman,RELIA,and Micropointwas good,while the detection range of Alere was small(0.01~10 ng/ml).There was a good correlation between Beckman and RELIA(R=0.944).The correlation between Beckman and Alere was also good within its detection range(R=0.931).The correlation between Micropoint and Beckman was poor(R=0.846).The consistency between the three detection reagents and Beckman was good(the detection value beyond 95%CI of LOA was less than 5%).Conclusions This experiment compares and analyzes the detection ability of the three in vitro diagnostic reagent methods and the common central laboratory methods in medical units,and shows the detection performance of three reagents,which provides theoretical basis and guidance for hospitals,chest pain centers,street township health service centers and other institutions or laboratories to select suitable in vitro diagnostic reagent.
作者
沈逸凡
陈子健
袁世栋
SHEN Yifan;CHEN Zijian;YUAN Shidong(RELIA BiotechnologyJiangsu,Inc,Taizhou 225316,iangsu;Department of Nuclear Medicine,Shanghai Tenth People’s Hospital,Shanghai 200072,China)
出处
《现代诊断与治疗》
CAS
2023年第6期804-809,共6页
Modern Diagnosis and Treatment
