丙型肝炎病毒游离核心抗原检测试剂盒临床考核数据分析 PDF

    [摘要] 目的 探讨国外丙型肝炎病毒游离核心抗原检测试剂盒的质量及可能的用途。方法 用该试剂对自然供血员及丙型肝炎可疑感染者血样共9215份血清进行检测，并对检测数据进行统计分析。结果 该试剂在9215份血清中筛出两份HCV游离核心抗原阳性血清，其中一份为抗原和抗体同时阳性血清，产生的抗体为核心区抗体。另外一份为单独游离核心抗原阳性血清。临床考核发现该试剂出现了较多的假阳性结果。结论 该检测系统可用于高通量检测；临床考核发现，该试剂可能检出了游离核心抗原单独阳性的窗口期样品；该试剂界值确定太低，出现了部分非特异结果，在这方面，该试剂还有待改进。

    [关键词] 肝炎病毒；试剂；临床考核

    Analysis of HCVcAg kit clinic trial

    YANG Zhen，QI Zi-bai，YU Yang，et al.

    National Institute for the Control of Pharmaceutical and Biology Products，Beijing 100050，China

    [Abstract] Objective To investigate the quality of one imported HCVcAg EIA kit and analyse this kit’s different uses.Methods 9215 sera were detected by HCVcAg EIA kit.The suspeuous samples were confirmed with confirmed neutralization test and RIBA，and we statistise these results in sucession.Results This kit founded two positive HCVcAg sera.One of two sera was positive antibody to core meantime，another one was only positive HCVcAg during the preseroconversion window.Conclusion We think this kit can efficacy detect hepatitis C core antigen during the preseroconversion window.We suggest the manufacture must establish the system of correct cutoff. ......