KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
KEMRI-Wellcome Trust Research Programme, PO Box 230, Kilifi, Kenya.
J Clin Virol. 2022 Jan;146:105061. doi: 10.1016/j.jcv.2021.105061. Epub 2021 Dec 27.
Many SARS-CoV-2 antibody detection assays have been developed but their differential performance is not well described. In this study we compared an in-house (KWTRP) ELISA which has been used extensively to estimate seroprevalence in the Kenyan population with WANTAI, an ELISA which has been approved for widespread use by the WHO. Using a wide variety of sample sets including pre-pandemic samples (negative gold standard), SARS-CoV-2 PCR positive samples (positive gold standard) and COVID-19 test samples from different periods (unknowns), we compared performance characteristics of the two assays. The overall concordance between WANTAI and KWTRP was 0.97 (95% CI, 0.95-0.98). For WANTAI and KWTRP, sensitivity was 0.95 (95% CI 0.90-0.98) and 0.93 (95% CI 0.87-0.96), respectively. Specificity for WANTAI was 0.98 (95% CI, 0.96-0.99) and 0.99 (95% CI 0.96-1.00) while KWTRP specificity was 0.99 (95% CI, 0.98-1.00) and 1.00 using pre-pandemic blood donors and pre-pandemic malaria cross-sectional survey samples respectively. Both assays show excellent characteristics to detect SARS-CoV-2 antibodies.
许多 SARS-CoV-2 抗体检测试剂盒已经开发出来,但它们的性能差异尚未得到很好的描述。在本研究中,我们比较了一种内部(KWTRP)ELISA,该 ELISA 已广泛用于估计肯尼亚人群的血清流行率,以及一种已被世界卫生组织批准广泛使用的 WANTAI ELISA。使用包括大流行前样本(阴性金标准)、SARS-CoV-2 PCR 阳性样本(阳性金标准)和不同时期的 COVID-19 测试样本(未知)在内的各种样本集,我们比较了两种检测方法的性能特征。WANTAI 和 KWTRP 的总体一致性为 0.97(95%CI,0.95-0.98)。对于 WANTAI 和 KWTRP,敏感性分别为 0.95(95%CI 0.90-0.98)和 0.93(95%CI 0.87-0.96)。WANTAI 的特异性为 0.98(95%CI,0.96-0.99)和 0.99(95%CI 0.96-1.00),而 KWTRP 的特异性分别为 0.99(95%CI 0.98-1.00)和 1.00,分别使用大流行前的献血者和大流行前的疟疾横断面调查样本。两种检测方法均显示出出色的 SARS-CoV-2 抗体检测特性。