丙型肝炎病毒抗体诊断试剂盒的诊断性能评价

Performance characteristics of the EIAgen hepatitis C virus antibody kit assay

目的通过与 Ortho 3.0丙型肝炎病毒(HCV)抗体诊断试剂盒比较,分析评价 EIAgenHCV 抗体诊断试剂盒(EIAgen)的诊断性能。方法应用考核试剂 EIAgen 和参比试剂 Ortho 3.0HCV 抗体诊断试剂盒对2881份样本进行检测,检测结果不一致时,应用重组免疫印迹试验(RIBA)确证试剂 RIBA HCV 3.0或核酸试验(NAT)确证试剂进行确证,以对结果进行综合分析。结果2881份样本中,考核试剂及参比试剂检测结果均为阳性,且参比试剂的测量值/临界值(S/CO)≥3.8,或检测结果符合确证试验阳性结果的阳性标本为274份,考核试剂及参比试剂检测结果均为阳性且参比试剂的S/CO<3.8为59份,阴性标本2539份,不确定的9份被剔除。考核试剂检测真阳性274份,无假阴性结果;真阴性2527份,假阳性12份。考核试剂敏感度为100%,高于参比试剂的98.91%;特异度为99.53%,略低于参比试剂的99.88%。考核试剂对部分国内常见 HCV 基因型(1a型、1b 型、2a 型、3型和6型)样本27份,均为真阳性,敏感度为100%,对于非 HCV 感染的病毒性肝炎、自身免疫性疾病及妊娠样本具有良好的特异度,特异度均为100%。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95.80%,阴性预测值为100%,准确性为99.57%。考核试剂S/C0≥5.9的样本301份,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29份,其中用参比试剂检测S/CO<3.8占86.21%。结论 EIAgen 敏感度100%,特异度较好,是一种优秀的检测抗-HCV EIAgen 试剂,尤其适用于阳性样本的筛选。采用 EIAgen 试剂检测样本,当S/CO≥5.9时,样本的阳性预测值较高。

Objective To compare the performance of EIAgen HCV kit （EIAgen HCV） versus the current Ortho HCV 3.0 Anti-HCV （Ortho 3. 0 HCV） assay in various clinical settings, such as blood banks and hepatology centers. Methods The two ELISA kits were evaluated simultaneously using a total of 2 881 specimens. All the results concordant positive for both assays and Ortho HCV result beyond 3.8 were classified as true positive （TP） or concordant negative for both assays as true negative （TN）. The discordant specimens were further comfirmed using either RIBA 3.0 or a homebrew nucleic acid testing （ NAT ） assay. Results Among the 2 881 specimens evaluated, 274 specimens were TP, 2 539 specimens were TN, and 9 cases were indeterminate. The sensitivity of EIAgen HCV was 100%, versus 98.91% for Ortho HCV while their respective specificities were 99. 53% and 99. 88%. Positive predictive and negative predictive values of 95.80% and 100% were respectively obtained for EIAgen HCV assay. Overall, the accuracy was 99. 57%. Specimens under various conditions containing potentially interfering substances, such as acute non-C hepatitis, autoimmune diseases, pregnant women, hemolysis, and lipoidemia, showed no interferencewith the two ELISAs. EIAgen HCV S/CO ratio values more than 5.9 would be highly predictive for the TP status of these specimens. Conclusions Our findings indicate that EIAgen HCV Kit is more sensitive than Ortho HCV 3.0 Test in detecting antibodies to HCV. EIAgen HCV Kit appears to be an excellent tool, not only for use in diagnostic settings, but also ideally suited for the screening of blood and blood products.