丙型肝炎病毒抗体诊断试剂盒（EIAgen HCV Ab Kit）的可信度分析  

Performance characteristics of the EIAgen hepatitis C virus antibody kit assay

作　　者：魏来[1] 管文莉[1] 饶慧瑛[1] 杜绍财[2] 祁自柏[3] 任英蓉[4] 

机构地区：[1]北京大学人民医院,北京100044 [2]北京大学肝病研究所,北京100044 [3]中国药品生物制品检定所,北京100050 [4]北京市红十字血液中心,北京100088

出　　处：《检验医学》2006年第B10期2-7,共6页Laboratory Medicine

摘　　要：目的分析丙型肝炎病毒（HCV）抗体酶联免疫吸附试验（ELISA）诊断试剂盒（EIAgen HCV Ab Kit）的可信度。方法应用考核试剂EIAgen HCV Ab Kit和参比试剂Ortho HCV 3．0 ELISA对2881例样本进行检测，检测结果不一致时，应用重组免疫印迹试验（RIBA）确证。所用试剂为RIBA HCV 3．0S IA或核酸试验（NAT），并对结果进行综合分析。结果2881例样本中，阳性样本333例，刚性样本2539例，9例不确定的样本被剔除。考核试剂检测真阳性333例，尢假阴性结果，真阴性2527例，假阳性12例。考核试剂灵敏度为100．00％，高于参比试剂：特异性为99．53％，略低于参比试剂。考核试剂对部分国内常见HCV基因型的灵敏度为100．00％，对于非HCV感染的病毒性肝炎、自身免疫件疾病及妊娠样本具有良好的特异性，特异性均为100．00％。溶血、脂血样本对考核试剂检测结果无影响。考核试剂阳性预测值为96．52％，阴性预测值为100．00％，符合率为99．58％。考核试剂S／CO≥5．9的样本301例，其中用参比试剂检测S／CO≥3．8占88．70％；考核试剂S／CO〈5．9的样本32例，其中用参比试剂检测S／CO〈3．8占87．50％。结论试剂EIAgen HCV Ab Kit灵敏度100．00％，特异性较女了，是一种优质的抗-HCV ELISA试剂，尤其适用于阳性样本的筛选。采用EIAgen HCV Ab Kit试剂检测样本，当S／CO≥5．9时，样本的阳性预测值比较高。Objective To study the performance characteristics of the EIAgen HCV Ab Kit versus the current Ortho HCV 3.0 EIA Anti-HCV assay with regards to sensitivity and specificity. Methods For 2 881 samples, the EIAgen HCV Ab Kit and the Ortho HCV 3.0 EIA Test assay were tested side-by-side. All same reactive samples in the two assays were true positive （TP） or true negative （TN） results. The discordant samples were retested in duplicate and final sample disposition was determined. If the results are not concordance still, the specimens repeatedly reactive were forwarded for confirmation testing, whereas RIBA HCV positive or NAT positive samples were classified as TP and RIBA HCV negative or NAT negative samples indicate TN. RIBA and NAT indeterminate results were rejected. Results Of the 2 881 sera evaluated, 333 were TP, 2 539 were TN, and 9 were indeterminate. For EIAgen assay, positive predictive value was 96.52%, negative predictive value was 100.00%, and roughly concordance rate was 99.58%. Apparent sensitivity of the EIAgen assay was 100.00%, compared to 99.10% for the current Ortho HCV 3.0 EIA Test assay. The specificity of the EIAgen assay was 99.53%, while of the Ortho assay was 99.88%. The potentially interfering substances, belonged to the following categories： non-hepatitis c virus, autoimmune diseases, pregnant, hemolysis, and lipoidemia, were not interferes in the two EIA assays. The samples with average s/co ratios 〉5.9 in EIAgen assay would be highly predictive of the TE Conclusions Our findings indicate that EIAgen HCV Ab Kit is more sensitive than Ortho HCV 3.0 EIA Test in detecting antibodies to HCV. The EIAgen HCV Ab Kit is an excellent tool not only for use in diagnostic settings, but also ideally suited for the screening of blood and blood products.

关 键 词：丙型肝炎病毒 抗体 试剂盒 酶联免疫吸附试验 灵敏度 特异性 

分 类 号：R446.6[医药卫生—诊断学]