Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19
Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19
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DOI：
10.1093/jalm/jfaa079
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发表时间：
2020-09-01
影响因子：
2
通讯作者：
Fitzgerald, Robert L.
中科院分区：
文献类型：
--
作者：
Suhandynata, Raymond T.;Hoffman, Melissa A.;Fitzgerald, Robert L.
背景资料：严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是一种新型β-冠状病毒，最近成为2019年冠状病毒大流行（COVID-19）的原因。基于聚合酶链反应（PCR）的测试是最佳的，并建议用于诊断急性SARS-CoV-2感染。病毒抗体的血清学检测为诊断既往病毒暴露提供了重要工具。在这里，我们评估了Diazyme SARS-CoV-2 IgM/IgG血清学检测的分析性能参数，并描述了在我院收治的PCR确认的COVID-19患者中观察到的IgM和IgG血清转换动力学。方法：我们在235名假定SARS-CoV-2阴性受试者中验证了Diazyme检测的性能，以确定特异性。随后，我们评估了54例PCR证实的COVID-19患者的SARS-CoV-2 IgM和IgG血清转换，并确定了该检测方法在三个不同时间段的灵敏度。结果：当检测IgM和IgG时，在SARS-CoV-2 PCR阳性结果后≥ 15天检测血清阳性的灵敏度和特异性分别为100.0%和98.7%。从阳性PCR的日期观察到的反应性IgM和IgG结果的血清阳性的中位时间分别为5天（IQR：2.75-9天）和4天（IQR：2.75-6.75天），Conclusions：我们的数据表明，Diazyme IgM/IgG检测适合检测SARS-CoV-2 IgG和IgM在疑似SARS-CoV-2感染的患者的目的。我们首次报告了美国急性病患者队列中IgG和IgM血清转换的纵向数据。我们还证明了假阳性率低的患者被假定为无病。
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a novel beta-coronavirus that has recently emerged as the cause of the 2019 coronavirus pandemic (COVID-19). Polymerase chain reaction (PCR) based tests are optimal and recommended for the diagnosis of an acute SARS-CoV-2 infection. Serology tests for viral antibodies provide an important tool to diagnose previous exposure to the virus. Here we evaluate the analytical performance parameters of the Diazyme SARS-CoV-2 IgM/IgG serology assays and describe the kinetics of IgM and IgG seroconversion observed in patients with PCR-confirmed COVID-19 who were admitted to our hospital.Methods: We validated the performance of the Diazyme assay in 235 presumed SARS-CoV-2 negative subjects to determine specificity. Subsequently, we evaluated the SARS-CoV-2 IgM and IgG seroconversion of 54 PCRconfirmed COVID-19 patients and determined sensitivity of the assay at three different timeframes.Result: Sensitivity and specificity for detecting seropositivity at >= 15 days following a positive SARS-CoV-2 PCR result, was 100.0% and 98.7% when assaying for the panel of IgM and IgG. The median time to seropositivity observed for a reactive IgM and IgG result from the date of a positive PCR was 5 days (IQR: 2.75-9 days) and 4 days (IQR: 2.75-6.75 days), respectively.Conclusions: Our data demonstrate that the Diazyme IgM/IgG assays are suited for the purpose of detecting SARS-CoV-2 IgG and IgM in patients with suspected SARS-CoV-2 infections. For the first time, we report longitudinal data showing the evolution of seroconversion for both IgG and IgM in a cohort of acutely ill patients in the United States. We also demonstrate a low false positive rate in patients who were presumed to be disease free.