R&D bioMérieux, Marcy l'Etoile, France
R&D bioMérieux, Marcy l'Etoile, France.
J Clin Microbiol. 2021 Mar 19;59(4). doi: 10.1128/JCM.02292-20.
The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemic, notably through epidemiological surveillance. Well-validated and highly specific SARS-CoV-2 serological assays are urgently needed. We describe here the analytical and clinical performance of Vidas SARS-CoV-2 IgM and Vidas SARS-CoV-2 IgG, two CE-marked, emergency use authorization (EUA)-authorized, automated, qualitative assays for the detection of SARS-CoV-2-specific IgM and IgG, respectively. Both assays showed high within-run and within-laboratory precision (coefficients of variation < 11.0%) and very low cross-reactivity toward sera of patients with a past common coronavirus or respiratory virus infection. Clinical specificity determined on up to 989 prepandemic healthy donors was ≥99% with a narrow 95% confidence interval for both IgM and IgG assays. Clinical sensitivity was determined on up to 232 samples from 130 reverse transcriptase PCR (RT-PCR)-confirmed SARS-CoV-2 patients. The positive percent agreement (PPA) with SARS-CoV-2 PCR reached 100% at ≥16 days (Vidas SARS-CoV-2 IgM) and ≥32 days (Vidas SARS-CoV-2 IgG) of symptom onset. Combined IgM/IgG test results improved the PPA compared to each test alone. SARS-CoV-2 IgG seroconversion followed closely that of SARS-CoV-2 IgM and remained stable over time, while SARS-CoV-2 IgM levels rapidly declined. Interestingly, SARS-CoV-2-specific IgM and IgG responses were significantly higher in COVID-19 hospitalized versus nonhospitalized patients. Altogether, the Vidas SARS-CoV-2 IgM and IgG assays are highly specific and sensitive serological tests suitable for the reliable detection of past acute SARS-CoV-2 infections.
新型严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）引起的 COVID-19 大流行继续在全球范围内传播。SARS-CoV-2 特异性抗体的血清学检测在了解和控制大流行方面发挥着重要作用，特别是通过流行病学监测。迫切需要经过良好验证且具有高度特异性的 SARS-CoV-2 血清学检测。我们在此描述了 VIDAS SARS-CoV-2 IgM 和 VIDAS SARS-CoV-2 IgG 的分析和临床性能，这两种检测方法均已获得 CE 标记、紧急使用授权（EUA）授权、自动化、定性检测 SARS-CoV-2 特异性 IgM 和 IgG。两种检测方法均表现出较高的批内和实验室内精密度（变异系数 < 11.0%），对既往常见冠状病毒或呼吸道病毒感染患者的血清交叉反应性极低。在多达 989 名大流行前健康供体上确定的临床特异性，两种 IgM 和 IgG 检测的 95%置信区间均很窄，均≥99%。在多达 232 份来自 130 名经逆转录酶聚合酶链反应（RT-PCR）确诊的 SARS-CoV-2 患者的样本中确定了临床敏感性。在症状出现后 16 天（VIDAS SARS-CoV-2 IgM）和 32 天（VIDAS SARS-CoV-2 IgG）以上，与 SARS-CoV-2 PCR 的阳性符合率（PPA）达到 100%。与单独使用每个检测相比，IgM/IgG 联合检测结果提高了 PPA。SARS-CoV-2 IgG 血清转换紧随 SARS-CoV-2 IgM 之后，并且随着时间的推移保持稳定，而 SARS-CoV-2 IgM 水平迅速下降。有趣的是，COVID-19 住院患者与非住院患者的 SARS-CoV-2 特异性 IgM 和 IgG 反应明显更高。总之，VIDAS SARS-CoV-2 IgM 和 IgG 检测是高度特异性和敏感的血清学检测，适合可靠检测过去急性 SARS-CoV-2 感染。
