Clinical performance of different SARS-CoV-2 IgG antibody tests
Clinical performance of different SARS-CoV-2 IgG antibody tests
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DOI：
10.1002/jmv.26145
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发表时间：
2020-06-19
影响因子：
12.7
通讯作者：
Rabenau, Holger F.
中科院分区：
文献类型：
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作者：
Kohmer, Niko;Westhaus, Sandra;Rabenau, Holger F.
严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）血清学检测是快速诊断、接触者追踪和流行病学研究的迫切需要。到目前为止，有关市售检测试剂盒如何使用真实的患者样本进行检测以及阳性检测样本是否显示中和能力的数据有限。针对IgG抗体，我们证明了两种酶联免疫吸附试验（ELISA）检测（Euroimmun SARS-CoV-2 IgG和Vircell COVID-19 ELISA IgG）与一种侧流检测（FaStep COVID-19 IgG/IgM快速检测装置）和两种内部开发的检测（免疫荧光检测[IFA]和空斑减少中和试验[PRNT]）相比的性能。我们检测了聚合酶链反应诊断为COVID-19的个体的后续血清/血浆样本。大多数SARS-CoV-2样本来自中度至重度临床病程的个体，他们需要住院治疗。对于所有检查的检测，感染早期（第5-9天）的灵敏度范围为58.8%至76.5%，晚期（第10-18天）的灵敏度范围为93.8%至100%。
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological assays are urgently needed for rapid diagnosis, contact tracing, and for epidemiological studies. So far, there is limited data on how commercially available tests perform with real patient samples, and if positive tested samples show neutralizing abilities. Focusing on IgG antibodies, we demonstrate the performance of two enzyme-linked immunosorbent assay (ELISA) assays (Euroimmun SARS-CoV-2 IgG and Vircell COVID-19 ELISA IgG) in comparison to one lateral flow assay (FaStep COVID-19 IgG/IgM Rapid Test Device) and two in-house developed assays (immunofluorescence assay [IFA] and plaque reduction neutralization test [PRNT]). We tested follow up serum/plasma samples of individuals polymerase chain reaction-diagnosed with COVID-19. Most of the SARS-CoV-2 samples were from individuals with moderate to the severe clinical course, who required an in-patient hospital stay. For all examined assays, the sensitivity ranged from 58.8 to 76.5% for the early phase of infection (days 5-9) and from 93.8% to 100% for the later period (days 10-18).