摘要
目的建立时间分辨荧光免疫的方法学性能验证方案和实验方法。方法参考CNAS-CL02:《医学实验室质量和能力认可准则》(ISO 15189:2012)对医学实验室检测系统性能评价的相关要求,结合实际工作需求,设计实验验证方案,并对全自动时间分辨荧光检测仪EASYCUTA测定乙肝五项,TP-Ab,HCV-Ab,HIV-Ab的精密度、正确度、线性分析测量范围、可检测极限、参考区间、分析灵敏度,抗干扰能力,交叉污染,方法学对比等进行验证和评价,并将检测结果与厂商(苏州新波公司)提供的性能指标进行比较。结果 EASYCUTA全自动时间分辨荧光检测系统检测HBV-M,TP,HCV,HIV项目的精密度、正确度、分析测量范围、可报告范围、参考区间、分析灵敏度、抗干扰能力、交叉污染,等均符合国际公认质量要求。方法学比对中,乙肝五项与Rochee601的阴阳性符合率>95%、K值评级为"优"。术前四项(HBsAg、TP、HCV、HIV)与Abbott i2000的阴阳性符合率>95%、K值评级为"优"。方法学对比合格。结论 EASYCUTA全自动时间分辨荧光检测仪测定乙肝五项,TP-Ab,HCV-Ab,HIV-Ab的主要分析性能验证结果与厂商说明书提供的分析性能一致,能够满足临床要求。本研究对规范医学实验室建设以及提供仪器检测质量具有重要的意义。
Objective The aim of study is to establish the program and methods for the performance verification of time-resolved fluoroimmuno assay (TRFIA).Methods According to the relevant requirements of Accreditation criteria for quality and capacity in medical laboratories(ISO 15189:2012),combined with the actual work requirements,we designed the experimental verification program.Hepatitis B virus markers (HBV-M),Syphilis antibody (TP-Ab ),Hepatitis C virus antibody (HCV-Ab)and Human immunodeficiency virus antibody (HIV-Ab )were detected by EASYCUTA analyzer.The precision,accuracy,measurement range,clinical reportable range,biological reference intervals,sensitivity,interference immunity,cross contamination and methodology comparison were obtained and analyzed.The test results were compared with those provided by the manufacturer (Suzhou XinBo Corporation).Results For the HBV-M,TP-Ab,HCV-Ab,HIV-Ab test results,the precision,accuracy,measurement range,clinical reportable range,biological reference intervals,sensitivity,interference immunity,cross-contamination of EASYCUTA were all consistent with the international standards.For the methodological comparison,the coincidence rate of HBV test with Roche e601was greater than 95%,and the K value was rated as excellent.The four markers of the infectiousdiseases(HBsAg,TP,HCV,HIV)with Abbott i2000 was greater than 95%,and the K value was rated as excellent.So the methodological comparisons were qualified.Conclusion The performance verification results that include HBV-M,TP-Ab,HCV-Ab,and HIV-Ab of EASYCUTA were consistent with the analytical performance defined by the manufacturer.It can meet the clinical requirements.This study provides very useful knowledge base for standardizing the construction of medical laboratory and estimating the quality of instrument testing.
作者
黄睿
贾海英
王昌敏
HUANG Rui;JIA Hai-ying;WANG Chang-min(Clinical Laboratory Center,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830001China)
出处
《标记免疫分析与临床》
CAS
2018年第11期1740-1746,共7页
Labeled Immunoassays and Clinical Medicine
基金
新疆地区急性HIV感染询证医学调查(编号:20160304)
关键词
时间分辨荧光免疫分析法
标记物
传染病
实验室质量
Time-resolved fluorescence immunoassay
Marker
Infectious diseases
Laboratory Quality
