Department of Pathology, Queen Elizabeth Hospital, Ministry of Health, Kota Kinabalu, Sabah, Malaysia.
Department of Biological Sciences and Biotechnology, Faculty of Science and Technology, The National University of Malaysia, Bangi, Selangor, Malaysia.
J Infect Dev Ctries. 2022 Mar 31;16(3):522-527. doi: 10.3855/jidc.13750.
The use of a signal-to-cut-off ratio has been recommended by the Centre for Disease Control and Prevention to determine the need for further validation using a supplemental test. In this study, we aimed to determine the optimal true-positive signal-to-cut-off ratio for the ABBOTT ARCHITECT i2000SR immunoassay (Abbott Laboratories, Illinois, USA), using the Serodia® HCV particle agglutination (HCV-PA) assay (Fujirebio Inc, Tokyo, Japan) as the reference test for anti-HCV screening.
We analysed a total of 13,240 specimens using the ARCHITECT i2000SR immunoassay and subsequently subjected all the reactive specimens with a signal-to-cut-off ratio ≥ 1.00 (n = 267) to the Serodia® HCV-PA reference assay. Receiver operating characteristic (ROC) curve analysis was carried out and performance characteristics for each signal-to-cut-off ratio were determined. The selected signal-to-cut-off ratio value was then assessed using a line immunoassay (LIA) test.
ROC curve analysis determined that the optimal signal-to-cut-off ratio was 5.05, which gave the highest Youden's Index (J) value of 0.89, with a sensitivity of 93.1% (88.9-97.2), a specificity of 96.0% (92.4-99.4), a positive predictive value of 96.4% (93.3-99.5), and a negative predictive value of 92.2% (87.5-96.8). Validation of the optimal S/Co value using the LIA test yielded an accuracy of 91.8%, with sensitivity and specificity values of 92.0% and 91.7%, respectively.
The optimal signal-to-cut-off ratio value for the ARCHITECT i2000SR immunoassay, which was determined using HCV-PA assay as the reference test and validated using a HCV-LIA assay, showed high sensitivity and specificity, and may be used in routine anti-HCV screening.
疾病控制与预防中心建议使用信号与截止值比来确定是否需要使用补充检测进行进一步验证。本研究旨在使用 Serodia® HCV 颗粒凝集（HCV-PA）检测（日本富士瑞必欧株式会社）作为抗 HCV 筛查的参考检测，确定 ABBOTT ARCHITECT i2000SR 免疫测定（雅培实验室，伊利诺伊州，美国）的最佳真阳性信号与截止值比。
我们使用 ARCHITECT i2000SR 免疫测定分析了总共 13240 份标本，随后将所有信号与截止值比≥1.00 的反应性标本（n=267）进行 Serodia® HCV-PA 参考检测。进行了接收器操作特性（ROC）曲线分析，并确定了每个信号与截止值比的性能特征。然后使用线免疫分析（LIA）检测评估选定的信号与截止值比。
ROC 曲线分析确定最佳信号与截止值比为 5.05，这给出了最高的 Youden 指数（J）值 0.89，敏感性为 93.1%（88.9-97.2），特异性为 96.0%（92.4-99.4），阳性预测值为 96.4%（93.3-99.5），阴性预测值为 92.2%（87.5-96.8）。使用 LIA 检测验证最佳 S/Co 值的准确性为 91.8%，敏感性和特异性值分别为 92.0%和 91.7%。
使用 HCV-PA 检测作为参考检测，使用 HCV-LIA 检测验证，确定 ARCHITECT i2000SR 免疫测定的最佳信号与截止值比具有较高的敏感性和特异性，可用于常规抗 HCV 筛查。
