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首页> 外文期刊>Journal of Clinical Microbiology >Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays
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Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays

机译：VIDAS SARS-COV-2 IgM和IgG血清学测定的性能特征

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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. ABSTRACT 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.
机译：由新的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理解和控制大流行中起着重要作用，特别是通过流行病学监测。摘要Covid-19大流行，由新的严重急性呼吸综合征冠状病毒2（SARS-COV-2）造成的，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理解和控制大流行中起着重要作用，特别是通过流行病学监测。迫切需要验证和高度特异的SARS-COV-2血清学测量。我们在此描述Vidas SARS-COV-2 IGM和VIDAS SARS-COV-2 IGG的分析和临床表现，两个CE标记，紧急使用授权（EUA） - 用于检测SARS-COV的自动化，定性测定-2特异性IgM和IgG。两种测定都显示出高次内和实验室精度（变异系数？＆amp; LT;＆amp; 11.0％），对患者的血清具有非常低的交叉反应性，具有过去常见的冠状病毒或呼吸道病毒感染。确定最多989名高效性健康供体的临床特异性≥99％，具有窄的95％置信区间，适用于IgM和IgG测定。从130次逆转录酶PCR（RT-PCR）确定最多232个样品的临床敏感性 - 确认的SARS-COV-2患者。 SARS-COV-2 PCR的阳性百分比（PPA）达到100％，≥16？天（VIDAS SARS-COV-2 IgM）和？≥32？天（VIDAS SARS-COV-2 IgG）症状发作。合并的IgM / IgG测试结果与单独的每次测试相比，PPA改善了PPA。 SARS-COV-2 IgG Seroconversion遵循SARS-COV-2 IgM，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住院患者的SARS-COV-2特异性IgM和IgG反应显着高于非生长的患者。总之，VIDAS SARS-COV-2 IgM和IgG测定是高度特异性和敏感的血清学检测，适用于可靠地检测过去急性SARS-COV-2感染。

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