高敏化学发光免疫法定量测定乙肝表面抗原的性能评价  

Applicable Evaluation of the Quantitative Determination of Hepatitis B Surface Antigen with Highly Sensitive Chemiluminescent Immunoassay

作　　者：谢思[1,2] 张卫云[1] 陈建芸[1] 石玉玲[1] 

机构地区：[1]广州军区广州总医院检验科,广东广州510010 [2]南方医科大学,广东广州510515

出　　处：《生物技术通讯》2016年第5期688-692,共5页Letters in Biotechnology

摘　　要：目的:验证和评价HISCL-5000化学发光分析仪检测乙肝表面抗原(HBsAg)的性能。方法:对HISCL-5000系统定量检测项目HBsAg的精密度、线性范围、临床特异性与临床灵敏度、携带污染率、干扰试验、血清转化盘进行性能评价,并验证其参考区间,与ARCHITECT-i2000进行方法学比对。结果:HBsAg的批内精密度、批间精密度CV均小于10%,线性范围高、中、低浓度的R^2>0.95,临床特异性97.7%,临床灵敏度100.0%,携带污染率小于1%,干扰项目结果符合临床要求,血清盘转化可检出HBsAg由阳到阴的血清转化,参考区间符合厂家要求;比对试验的结果 R^2>0.95且总一致率达到93%。结论:HISCL-5000定量检测HBsAg具有高灵敏度、高特异性、线性宽、重复性好、准确度佳、快速、简便等优点,能大大提高HBsAg的检出率,很好地满足临床需要。Objective： To validate and evaluate performance of HISCL-5000 chemiluminescence analyzer in de-tection of hepatitis B surface antigen（HBsAg）. Methods： The HBsAg system precision, linear test, clinical sensitiv-ity and clinical specificity, carryover, interference test, seroconversion disk performance evaluation and verify thereference intervals, the results were compared and analyzed with ARCHITECT-i2000. Results： Both intraassay andinterasssy coefficient variation were less than 10%. HISCL-5000 HBsAg high middle low concentration linear testssuggested that R^2 was above 0.95. Clinical specificity 97.7%, clinical sensitivity 100.0%. Carryover was less than 1%. The sample results of interference requirements were consistent with the clinical. Using serum disctransforma-tion can be detected the positive to negative seroconversion by HISCL-5000 or ARCHITECT-i2000. Reference in-tervals in line with the requirements of manufacturers. Comparison test results R^2〉0.95 and a total consistent rateof 93%. Conclusion： HISCL-5000 quantitative detection of HBsAg with high sensitivity, high specificity, linearitywidth, better repeatability and accuracy, fast, easy, etc., can greatly improve the detection rate of HBsAg, good tomeet clinical needs.

关 键 词：乙肝表面抗原 化学发光免疫法 定量 性能评价 

分 类 号：R446.12[医药卫生—诊断学]