He Yuting, Chen Yao, Wang Yichong, Chen Xuefang, Huang Hao, Yu Xuegao, He Xiaohong, Zeng Wentao, Liu Min, Huang Bin, Chen Peisong
Clin Lab. 2020 Aug 1;66(8). doi: 10.7754/Clin.Lab.2020.191208.
The aim of the study is to evaluate the significance of the Architect anti-HCV signal to cutoff (S/CO) ratios for predicting hepatitis C viremia and determine the optimal S/Co ratio value for Architect anti-HCV assay.
The results of patients who underwent HCV RNA quantitative assays because of positive anti-HCV from January 2015 to August 2019 were retrospectively analyzed, including S/Co ratio values, HCV RNA quantitative results, alanine aminotransferase (ALT), and aspartate transaminase (AST) values. Binary logistic regression and Spearman's correlation coefficient were used to analyze the collected data. Receiver-operating characteristics curve (ROC) was applied to analyze the predicting values of the indexes.
In total, 811 patients were included in our study and HCV viremia was detected in 342 (42.1%) patients. There is no correlation between anti-HCV S/CO ratio and HCV RNA level. The samples with an S/Co ratio between 1 and 4 (271/271, 100%) were all HCV RNA negative. The area under the ROC curve of anti-HCV S/CO ratio was 0.8714 and the maximal Youden index was 0.681 at an optimal cutoff S/CO ratio value of 8.99.
With the cutoff value of 1.0, the Architect anti-HCV assay showed excellent sensitivity but poor specificity in predicting HCV viremia. An S/Co ratio of 8.99 was optimal for further confirmation testing of HCV viremia.
本研究旨在评估Architect抗-HCV信号与临界值（S/CO）比值对预测丙型肝炎病毒血症的意义，并确定Architect抗-HCV检测的最佳S/Co比值。
回顾性分析2015年1月至2019年8月因抗-HCV阳性而接受HCV RNA定量检测的患者结果，包括S/Co比值、HCV RNA定量结果、丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）值。采用二元逻辑回归和Spearman相关系数分析所收集的数据。应用受试者工作特征曲线（ROC）分析各指标的预测价值。
本研究共纳入811例患者，其中342例（42.1%）检测到HCV病毒血症。抗-HCV S/CO比值与HCV RNA水平之间无相关性。S/Co比值在1至4之间的样本（271/271，100%）均为HCV RNA阴性。抗-HCV S/CO比值的ROC曲线下面积为0.8714，在最佳临界S/CO比值为8.99时，最大约登指数为0.681。
临界值为1.0时，Architect抗-HCV检测在预测HCV病毒血症方面显示出优异灵敏度，但特异性较差。S/Co比值为8.99是进一步确认HCV病毒血症检测的最佳选择。
