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目的对于用ELISA法检测HCV-Ab结果在临界值周围的可疑标本,用核酸扩增及微流芯片法进一步检测,以探讨不同方法丙型肝炎病毒(HCV)的检出率及其感染的危险性。方法收集住院患者中经2种不同的HCV-Ab ELISA法试剂1或试剂2检测结果 S/CO≥0.4至<1.0的血清标本24份,其金标试纸条法检测均为阴性,分别用核酸扩增及微流芯片法和化学发光免疫分析(CLIA)测HCV-Ab法进行检测。结果 24份用ELISA法检测S/CO值处于临界值的标本,经核酸扩增及微流芯片法检测阳性16份(阳性率66.67%),CLIA测HCV-Ab法检测阳性16份(阳性率66.67%),HCV-Ab ELISA法试剂1阳性6份(阳性率25.00%),试剂2阳性10份(阳性率41.67%)。核酸扩增及微流芯片分析法与ELISA法试剂1检测结果进行比较,阳性率差异有统计学意义(P<0.01),与ELISA法试剂2检测结果进行比较,阳性率差异有统计学意义(P<0.05)。结论核酸扩增及微流芯片分析法对HCV的检出率高于ELISA法和金标试纸条法,因此,对ELISA法检测HCV-Ab结果在临界值周围的可疑标本,可能存在感染性,应对这些可疑标本做进一步的检测,可选择性的应用核酸扩增及微流芯片分析法和化学发光免疫分析(CLIA)法等方法联合进行检测,以提高检测结果的准确性,以防误检和漏检。
Objective To detect the suspicious samples with HCV-Ab results around the critical value by ELISA and to further detect by using nucleic acid amplification and microfluidic chip method to explore the different detection methods of hepatitis C virus (HCV) and its risk of infection Sex. Methods Twenty-four serum samples from two different HCV-Ab ELISA reagents 1 or 2 were detected in patients with S / CO ≥ 0.4 to <1.0. The gold standard test strips were negative, Nucleic acid amplification and microfluidic chip method and chemiluminescence immunoassay (CLIA) detection of HCV-Ab method. Results 24 samples with S / CO value at critical value were detected by ELISA. 16 positive samples (66.67% positive) were detected by nucleic acid amplification and micro-flow cytometry, and 16 positive samples were detected by CLIA assay (positive rate 66.67%), HCV-Ab ELISA reagent 1 positive 6 (positive rate 25.00%), reagent 2 positive 10 (positive rate 41.67%). The positive rate of nucleic acid amplification and microfluidic chip analysis was significantly higher than that of ELISA reagent 1 (P <0.01). The positive rate was significantly different from that of ELISA reagent 2 (P <0.01) P <0.05). Conclusion The detection rate of HCV in nucleic acid amplification and microfluidic chip analysis is higher than that of ELISA and gold strip test. Therefore, the suspicious samples with HCV-Ab results around the critical value by ELISA may have infectivity , These suspicious specimens should be further tested, and the combination of nucleic acid amplification and microfluidic chip analysis and chemiluminescence immunoassay (CLIA) can be used in combination to improve the accuracy of the test results to prevent errors Check and missed inspection.