Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloška 4, 1000, Ljubljana, Slovenia.
Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloška 4, 1000, Ljubljana, Slovenia.
J Clin Virol. 2021 Apr;137:104784. doi: 10.1016/j.jcv.2021.104784. Epub 2021 Mar 5.
Accurate anti-SARS-CoV-2 assays are needed to inform diagnostic, therapeutic, and public health decisions. The first manufacturer-independent head-to-head comparison of two rapid high-throughput automated electrochemiluminescence double-antigen sandwich immunoassays targeting total anti-SARS-CoV-2 antibodies against two different viral proteins, Elecsys Anti-SARS-CoV-2 (Elecsys-N) and Elecsys Anti-SARS-CoV-2 S (Elecsys-S) (Roche Diagnostics), was performed in a routine setting during the exponential growth phase of the epidemic's second wave.
The diagnostic specificity of Elecsys-N and Elecsys-S was initially evaluated on a panel of 572 pre-COVID-19 samples, showing 100 % specificity of both assays. Elecsys-N/Elecsys-S head-to-head comparison used 3,416 consecutive blood samples from individuals that were tested for the presence of anti-SARS-CoV-2 within commercial out-of-pocket serologic testing.
Elecsys-N/Elecsys-S head-to-head comparison showed overall agreement of 98.68 % (3,371/3,416; 95 % CI, 98.23-99.03 %), positive agreement of 95.16 % (884/929; 95 % CI, 93.52-96.41 %), and a high kappa value of 0.996 (95 % CI, 0.956-0.976). Previous SARS-CoV-2 PCR positivity was identified in 14/24 (58.3 %) Elecsys-N negative/Elecsys-S positive individuals and in 4/21 (19.0 %) Elecsys-N positive/Elecsys-S negative individuals.
The first Elecsys-N/Elecsys-S head-to-head comparison showed excellent agreement of two highly specific and rapid high-throughput automated anti-SARS-CoV-2 assays. An important question is whether laboratories offering two different antibody assays could benefit from combining the assays; if so, should use be concomitant or sequential-and, in the latter case, in which order? Based on our results, we favor concomitant over sequential Elecsys-N/Elecsys-S use when testing individuals for anti-SARS-CoV-2 antibodies in high-incidence settings; for example, during the exponential or stationary growth phase of the COVID-19 epidemic.
需要准确的抗 SARS-CoV-2 检测方法来为诊断、治疗和公共卫生决策提供信息。我们首次在疫情第二波指数增长阶段，在常规环境下对两种针对不同病毒蛋白的总抗 SARS-CoV-2 抗体的快速高通量自动化电化学发光双抗原夹心免疫测定法（罗氏诊断 Elecsys Anti-SARS-CoV-2 [Elecsys-N] 和 Elecsys Anti-SARS-CoV-2 S [Elecsys-S]）进行了制造商之间的头对头比较。
在包含 572 例新冠病毒前样本的面板中，我们首先评估了 Elecsys-N 和 Elecsys-S 的诊断特异性，两种检测方法均具有 100%的特异性。使用来自进行商业自费血清学检测的个体的 3416 例连续血样进行 Elecsys-N/Elecsys-S 头对头比较。
Elecsys-N/Elecsys-S 头对头比较显示总符合率为 98.68%（3371/3416；95%置信区间，98.23-99.03%），阳性符合率为 95.16%（884/929；95%置信区间，93.52-96.41%），kappa 值为 0.996（95%置信区间，0.956-0.976）。在 14/24（58.3%）Elecsys-N 阴性/Elecsys-S 阳性个体和 4/21（19.0%）Elecsys-N 阳性/Elecsys-S 阴性个体中，发现之前的 SARS-CoV-2 PCR 阳性。
首次 Elecsys-N/Elecsys-S 头对头比较显示两种高度特异性和快速高通量自动化抗 SARS-CoV-2 检测方法具有极好的一致性。一个重要的问题是，提供两种不同抗体检测方法的实验室是否可以从联合使用这些检测方法中受益；如果可以，应该同时使用还是序贯使用，在后一种情况下，应按哪种顺序？基于我们的结果，我们赞成在高发病率环境中对个体进行抗 SARS-CoV-2 抗体检测时同时使用 Elecsys-N/Elecsys-S，例如在 COVID-19 疫情的指数增长或稳定增长阶段。
