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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 To find out the suitable HCV antibody to detect the S / CO value and predict its correlation with the presence of HCV RNA or the titer of HCV RNA. Methods A multi-stage random sampling method was used to extract 1,000 Li nationality from Hainan province from August to October 2014 as the research object. The two blood samples were tested for dual-reagent antibody by using anti-HCV ELISA reagent of Zhuhai Livzon and Shanghai Kehua, and HCV RNA quantitative detection of HCV ELISA double reagent-positive samples. The ROC curves were used to determine the S / CO value of the two ELISA reagents for the diagnostic significance of HCV RNA negative / positive. Results The size of S / CO in ELISA was significantly different between viremia and non-viremia (Zhuhai Lizhu P = 7.15E-21; Shanghai Kehua P = 3.00E-21). According to the analysis of ROC curves, the optimal S / CO threshold values of Zhuhai Livzon and Shanghai Kehua are 14.05 and 8.54, respectively. The best threshold of both reagents can reach more than 90% negative predictive value. The above two reagents in the prediction of HCV viremia should pay attention to gender differences in gender and sensitivity can occur there is a difference. Correlation analysis showed that the correlation between S / CO value of ELISA and HCV virus titer was not statistically significant. Conclusion The best S / CO threshold can be found in both anti-HCV ELISA reagent of Zhuhai Livzon and Shanghai Kehua, and the positive result of HCV RNA can be predicted by S / CO value.