海南黎族人群中抗-HCV ELISA S/CO值与HCV RNA相关性研究

Study on the correlation of the anti-HCV ELISA S/CO ratios and HCV RNA tests among Li minority of Hainan province

目的寻找合适的HCV抗体检测S/CO值,预测其与HCV RNA的存在或者滴度高低的相关性。方法采用多阶段随机抽样方法,抽取2014年8-10月1 000名海南省黎族人群作为研究对象。采用珠海丽珠和上海科华抗-HCV ELISA试剂对上述血液标本进行双试剂抗体检测,对HCV ELISA双试剂阳性的标本进行HCV RNA定量检测。利用ROC曲线判断两种ELISA试剂的S/CO值对于HCV RNA阴/阳性的诊断意义。结果 ELISA检测中S/CO的大小在病毒血症与非病毒血症中的差异有统计学意义(珠海丽珠P=7.15E-21;上海科华P=3.00E-21)。根据ROC曲线的分析结果显示珠海丽珠和上海科华的最佳S/CO阈值分别为14.05和8.54。二种试剂的最佳阈值均可达到90%以上的阴性预测率。上述两个试剂在预测HCV病毒血症时要注意男女性别差异可出现灵敏度和特异度的差异。相关性分析发现ELISA检测的S/CO值与HCV病毒滴度高低的关联无统计学意义。结论珠海丽珠和上海科华抗-HCV ELISA试剂均可找到其最佳的S/CO阈值,可以通过S/CO值预测HCV RNA的阳性结果。

Objective Heptatitis C Virus（HCV） infection is diagnosed by the presence of anti-HCV antibody. HCV RNA test is introduced as gold standard to confirm viremia to follow treatment. However, HCV RNA test is not widely used because of the high cost and equipments required. Our aim is to investigate the correlation of the anti-HCV ELISA S / CO ratios with HCV RNA test results and to predict the presence or the titer of HCV RNA. Methods 1000 general persons of Li minority were recruited and screened by anti-HCV ELISA assays（Lizhu and Kehua assay）. A total of 223 both anti-HCV positive patients were tested for HCV-RNA by quantitative methods using diagnostic Kit for Quantification of Hepatitis C Virus RNA. Statistical analysis was done by SPSS version 16. Results Significant difference in S / CO ratio between viremic and nonviremic subjects was observed. ROC curves indicated that the S / CO ratios were correlated with HCV RNA test results. The optimal S / CO ratio was defined by the maximum Youden index. The optimal S / CO ratios for Lizhu, Hehua assays were 14.05 and 8.54, respectively. The negative predictive values were both over 90%under the optimal S / CO. The difference of male and female should be considered according to results. There was no correlation between S / CO ratios and HCV-RNA level. Conclusion Each ELISA assay presents specific optimal S / CO ratio, which can be used to predict positive results of HCV RNA tests.