The Elecsys® Anti-SARS-CoV-2 S immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) has been developed for the detection of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. We evaluated the assay performance using samples from seven sites in Germany, Austria, and Switzerland. For specificity and sensitivity analyses, 7880 presumed negative pre-pandemic samples and 827 SARS-CoV-2 PCR-confirmed single or sequential samples from 272 different patients were tested, respectively. The overall specificity and sensitivity (≥14 days post-PCR) for the Elecsys Anti-SARS-CoV-2 S immunoassay were 99.95% (95% confidence interval [CI]: 99.87–99.99; 7876/7880) and 97.92% (95% CI: 95.21–99.32; 235/240), respectively. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher specificity compared with the LIAISON® SARS-CoV-2 S1/S2 IgG (99.95% [2032/2033] vs 98.82% [2009/2033]), ADVIA Centaur® SARS-CoV-2 Total (100% [928/928] vs 86.96% [807/928]), ARCHITECT SARS-CoV-2 IgG (99.97% [2931/2932] vs 99.69% [2923/2932]), iFlash-SARS-CoV-2 IgM (100.00% [928/928] vs 99.57% [924/928]), and EUROIMMUN Anti-SARS-CoV-2 IgG (100.00% [903/903] vs 97.45% [880/903]) and IgA (100.00% [895/895] vs 95.75% [857/895]) assays. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher sensitivity (≥14 days post-PCR) compared with the ARCHITECT SARS-CoV-2 IgG (98.70% [76/77] vs 87.01% [67/77]), iFlash-SARS-CoV-2 IgG (100.00% [76/76] vs 93.42% [71/76]) and IgM (100.00% [76/76] vs 35.53% [27/76]), and EUROIMMUN Anti-SARS-CoV-2 IgG (98.26% [113/115] vs 93.91% [108/115]) assays. Therefore, the Elecsys Anti-SARS-CoV-2 S assay demonstrated a reliable performance across various sample populations for the detection of anti-S antibodies.

Elecsys® Anti-SARS-CoV-2 S 免疫测定（Roche Diagnostics International Ltd, Rotkreuz, Switzerland）已开发用于检测严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 刺突 (S) 蛋白的抗体. 我们使用来自德国、奥地利和瑞士七个地点的样本评估了检测性能。对于特异性和敏感性分析，分别测试了来自 272 名不同患者的 7880 个大流行前假定阴性样本和 827 个 SARS-CoV-2 PCR 确认的单个或连续样本。Elecsys 抗 SARS-CoV-2 S 免疫测定的总体特异性和敏感性（PCR 后≥14 天）分别为 99.95%（95% 置信区间 [CI]：99.87–99.99；7876/7880）和 97.92%（95 % CI：95.21–99.32；235/240）。与 LIAISON® SARS-CoV-2 S1/S2 IgG（99.95% [2032/2033] 对比 98.82% [2009/2033]）、ADVIA Centaur® 相比，Elecsys Anti-SARS-CoV-2 S 免疫测定具有显着更高的特异性SARS-CoV-2 总计（100% [928/928] 对比 86.96% [807/928]），ARCHITECT SARS-CoV-2 IgG（99.97% [2931/2932] 对比 99.69% [2923/2932]），iFlash -SARS-CoV-2 IgM（100.00% [928/928] 对比 99.57% [924/928]）和 EUROIMMUN 抗 SARS-CoV-2 IgG（100.00% [903/903] 对比 97.45% [880/903 ]) 和 IgA（100.00% [895/895] 对比 95.75% [857/895]）测定。与 ARCHITECT SARS-CoV-2 IgG（98.70% [76/77] 对 87.01% [67/77]）相比，Elecsys Anti-SARS-CoV-2 S 免疫测定具有显着更高的灵敏度（PCR 后≥14 天） 、iFlash-SARS-CoV-2 IgG（100.00% [76/76] 对 93.42% [71/76]）和 IgM（100.00% [76/76] 对 35.53% [27/76]）和 EUROIMMUN 抗SARS-CoV-2 IgG（98.26% [113/115] 对比 93. 91% [108/115]) 化验。因此，Elecsys Anti-SARS-CoV-2 S 检测在各种样本群体中展示了可靠的抗 S 抗体检测性能。