SYSMEX HISCL5000化学分析仪检测乙肝血清标志物性能评价  

Clinical performance evaluation of HBV serological biomarkers using SYSMEX HISCL5000 chemiluminescence analyzer

作　　者：郑齐锶 戴蕾[1] 陶月[1] 宁明哲[1] 

机构地区：[1]南京大学医学院附属鼓楼医院检验科,南京210008

出　　处：《医疗卫生装备》2017年第9期90-92,104,共4页Chinese Medical Equipment Journal

摘　　要：目的:分析SYSMEX HISCL5000全自动高敏化学发光免疫分析仪(以下简称"HISCL5000化学分析仪")检测乙肝血清标志物的性能。方法:用HISCL5000化学分析仪分别检测乙肝表面抗原(HBsAg)、乙肝表面抗体(HBsAb)、乙肝e抗原(HBeAg)、乙肝e抗体(HbeAb)、乙肝核心抗体(HbcAb),分析其精密度、携带污染率、线性检测范围、一致率、生物参考区间、检出限等指标,并按美国临床实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)EP系列文件的要求,评价其验证结果。结果 :HISCL5000化学分析仪检测乙肝血清标志物时,批内精密度变异系数(coefficient of variation,CV)为0.60%~4.17%,批间精密度CV为0.04%~5.35%;线性验证中,r^2值为0.980 5~0.998 7,a值为0.970 9~1.022 6;携带污染率为0.00%;与其他方法检测结果符合率为96.00%~100.00%;生物参考区间和检出限验证均合格。结论:HISCL5000化学分析仪可以满足临床工作的需要,可用于检测乙肝血清标志物。Objective To assess the detection performance of SYSMEX HISCL5000 automatic chemiluminescence immunoassay analyzer for serum hepatitis B virus（HBV） biomarkers. Methods Serological HBV biomarkers, including HBs Ag, HBs Ab, HBe Ag, Hbe Ab and Hbc Ab, were measured by HISCL5000 analyzer. Further, a panel of parameters were analyzed, including precision, cross contamination rate, linear range, concordance rate, biological reference interval and limit of detection. According to the guideline from Clinical Laboratory Standards Institues（CLSI） EP system, the potential clinical application of using HISCL5000 analyzer to measure serum HBV biomarkers were evaluated. Results A panel of five serum HBV biomarkers was measure by using HISCL5000 analyzer. The coefficient of variation（CV） value of the within-run imprecision was from 0.60% to 4.17%, and CV value of the between-run imprecision was from 0.04% to 5.35%. Linear verification showed that r^2 was between 0.980 5 and 0.998 7, and a was between 0.970 9 and 1.022 6. The ratio of cross contamination was 0.00%. The coincident rate of HISCL5000 analyzer with other methods was between 96.00% and 100.00%.Biological reference interval and limit of detectionderived from this analyzer were also proved qualified. Conclusion HISCL5000 analyzer can be used clinically to detect HBV biomarkers.

关 键 词：SYSMEX HISCL5000化学分析仪 乙肝两对半 血清标志物 乙肝 性能评价 

分 类 号：R446.6[医药卫生—诊断学] R512.62[医药卫生—临床医学]