摘要
目的 对研制的丙型肝炎病毒（HCV）抗体检测试剂（双抗原夹心法）在高危人群中的应用进行评价，并与间接法进行比较。方法 收集河北省固安县丙型肝炎高发地区A村38份、B村47份，共85份样品，采用研制的抗-HCV检测试剂（双抗原夹心法）及间接法同时测定样品抗-HCV，对检测结果不符的样品用HCV-RIBA补充试剂进行确认。结果 85份样品中，间接法检测阳性76份（89．41％），阴性9份；双抗原夹心法检出阳性73份（85．88％），阴性12份。有3份间接法检测弱阳性，而双抗原夹心法检测为阴性，经HCV-RIBA补充试剂确认2份为阴性，1份仅1条带阳性，再经病毒核酸定量检测为（1．2～4．8）×10^2copies／ml，HCVRNA测定为阴性。结论 研制的双抗原夹心法抗-HCV检测试剂的灵敏度与间接法相同，特异性优于间接法。
Objective The sensitivities and specificities of two commercial available kits,anti-HCV detection method （double antigen sandwich） and indirect detection method （ELISA） were compared in risk population. Methods 85 samples were collected in Gu＇an of Hebei province which was the high-risk area of HCV. All of the samples were detected by anti- HCV detection kit （double antigen sandwich） and indirect detection kit. The inconsistent samples were detected again by HCV-RIBA supplementary reagent. Results Among the 85 samples,76 positive samples （89.41%） and 9 negative samples were detected using indirect method,while 73 positive samples （85.88%） and 12 negative samples were detected using anti- HCV double antigen sandwich detection method. 3 samples that were weak positive by indirect detection method and that were negative by sandwish detection method. There was only one sample with one line was detected by HCV-RIBA kit, The virus load was （1.2～4.8）× 10^2 copies/ml, which was HCV RNA negative. Conclusion In risk population, the sen-sitivities of the two methods are the same, but the specificity of the anti-HCV double antigen sandwich detection method is better than that of the indirect detection method.
出处
《临床输血与检验》
CAS
2008年第2期97-98,共2页
Journal of Clinical Transfusion and Laboratory Medicine
基金
国家高技术研究发展计划(863)(No2006-AA020907)资助
