The Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide accurate, reliable detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated sensitivity, specificity, cross-reactivity, and agreement with a vesicular stomatitis virus-based pseudoneutralization assay for the Elecsys Anti-SARS-CoV-2 immunoassay. Sensitivity and agreement between Elecsys Anti-SARS-CoV-2 immunoassay and pseudoneutralization assay measurements were evaluated using samples from patients with PCR-confirmed SARS-CoV-2 infection, a majority of whom were hospitalized. Specificity was evaluated using samples from routine diagnostic testing/blood donors collected before December 2019 and thus deemed negative for SARS-CoV-2-specific antibodies. Cross-reactivity was evaluated using samples containing a wide range of potentially cross-reacting analytes, purchased from commercial vendors. For sensitivity and specificity, point estimates and 95% confidence intervals (CIs) were calculated. Agreement between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay was calculated. The sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in patients with prior PCR-confirmed SARS-CoV-2 infection was 99.5% (95% CI, 97.0 to 100.0%) at ≥14 days post-PCR confirmation. Overall specificity (n = 10,453) was 99.80% (95% CI, 99.69 to 99.88%). Only 4/792 samples containing potential cross-reacting analytes were reactive with the Elecsys Anti-SARS-CoV-2 immunoassay, resulting in an overall specificity in this cohort of 99.5% (95% CI, 98.6 to 99.9%). Positive, negative, and overall agreement (n = 46) between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay were 86.4% (95% CI, 73.3 to 93.6%), 100% (95% CI, 34.2 to 100%), and 87.0% (95% CI, 74.3 to 93.9%), respectively. The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated high sensitivity (99.5% at ≥14 days post-PCR confirmation) and specificity (99.80%), supporting its use as a tool for identification of past SARS-CoV-2 infection, including use in populations with low disease prevalence.

中文翻译：

---

Elecsys 抗 SARS-CoV-2 免疫测定法的开发和验证作为确定过去是否接触过 SARS-CoV-2 的高度特异性工具。

Elecsys 抗 SARS-CoV-2 免疫测定（罗氏诊断）旨在准确、可靠地检测严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的抗体。我们评估了 Elecsys 抗 SARS-CoV-2 免疫测定的敏感性、特异性、交叉反应性以及与基于水泡性口炎病毒的假中和测定的一致性。使用 PCR 确诊的 SARS-CoV-2 感染患者（其中大多数已住院）的样本评估了 Elecsys 抗 SARS-CoV-2 免疫测定和假中和测定测量之间的灵敏度和一致性。使用 2019 年 12 月之前收集的常规诊断测试/献血者样本评估特异性，因此认为 SARS-CoV-2 特异性抗体呈阴性。使用从商业供应商购买的含有多种潜在交叉反应分析物的样品来评估交叉反应性。对于敏感性和特异性，计算了点估计值和 95% 置信区间 (CI)。计算了 Elecsys 抗 SARS-CoV-2 免疫测定与假中和测定之间的一致性。在 PCR 确认后 ≥14 天时，Elecsys 抗 SARS-CoV-2 免疫测定对于既往经 PCR 确认的 SARS-CoV-2 感染的患者的敏感性为 99.5%（95% CI，97.0 至 100.0%）。总体特异性 ( n = 10,453) 为 99.80% (95% CI, 99.69 至 99.88%)。只有 4/792 个含有潜在交叉反应分析物的样本与 Elecsys Anti-SARS-CoV-2 免疫测定发生反应，导致该队列的总体特异性为 99.5%（95% CI，98.6 至 99.9%）。Elecsys 抗 SARS-CoV-2 免疫测定与假中和测定之间的阳性、阴性和总体一致性 ( n = 46) 分别为 86.4%（95% CI，73.3 至 93.6%）、100%（95% CI，34.2 至 93.6%）分别为 100%）和 87.0%（95% CI，74.3 至 93.9%）。Elecsys 抗 SARS-CoV-2 免疫测定法表现出高灵敏度（PCR 确认后≥14 天为 99.5%）和特异性（99.80%），支持其用作识别过去 SARS-CoV-2 感染的工具，包括在疾病流行率低的人群中使用。