Coronavirus disease (COVID) serological tests are essential to determine the overall seroprevalence of a population and to facilitate exposure estimates within that population. We performed a head-to-head assessment of enzyme immunoassays (EIAs) and point-of-care lateral flow assays (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies. Demographics, symptoms, comorbidities, treatment, and mortality of patients whose sera were used were also reviewed. Six EIAs (Abbott, Affinity, Bio-Rad, DiaSorin, Euroimmun, and Roche) and six POCTs (BTNX, Biolidics, Deep Blue, Genrui, Getein BioTech, and Innovita) were evaluated for the detection of SARS-CoV-2 antibodies in known COVID-19-infected individuals. Sensitivity of EIAs ranged from 50 to 100%, with only four assays having overall sensitivities of >95% after 21 days after symptom onset. Notably, cross-reactivity with other respiratory viruses (parainfluenza virus [PIV-4] [n = 5], human metapneumovirus [hMPV] [n = 3], rhinovirus/enterovirus [n = 1], CoV-229E [n = 2], CoV-NL63 [n = 2], and CoV-OC43 [n = 2]) was observed; however, overall specificity of EIAs was good (92 to 100%; all but one assay had specificity above 95%). POCTs were 0 to 100% sensitive >21 days after onset, with specificity ranging from 96 to 100%. However, many POCTs had faint banding and were often difficult to interpret. Serology assays can detect SARS-CoV-2 antibodies as early as 10 days after symptom onset. Serology assays vary in their sensitivity based on the marker (IgA/IgM versus IgG versus total) and by manufacturer; however, overall only 4 EIAs and 4 POCTs had sensitivities of >95% >21 days after symptom onset. Cross-reactivity with other seasonal coronaviruses is of concern. Serology assays should not be used for the diagnosis of acute infection but rather in carefully designed serosurveys to facilitate understanding of seroprevalence in a population and to identify previous exposure to SARS-CoV-2.

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评估六种商业中型至大容量抗体和六种护理点横向流动分析法以检测SARS-CoV-2抗体。

冠状病毒疾病（COVID）血清学测试对于确定人群的总体血清阳性率并促进该人群的暴露估计至关重要。我们进行了酶免疫测定（EIA）和即时护理侧流测定（POCT）的全面评估，以检测严重的急性呼吸综合征冠状病毒2（SARS-CoV-2）抗体。还回顾了使用血清的患者的人口统计学，症状，合并症，治疗和死亡率。对六个EIA（Abbott，Affinity，Bio-Rad，DiaSorin，Euroimmun和Roche）和六个POCT（BTNX，Biolidics，Deep Blue，Genrui，Getein BioTech和Innovita）进行了评估，以检测SARS-CoV-2抗体已知感染COVID-19的个体。EIA的灵敏度范围为50％至100％，仅四种测定的总灵敏度> 症状发作21天后95％。值得注意的是，它与其他呼吸道病毒（副流感病毒[PIV-4] [n = 5]，人间质肺病毒[hMPV] [ n = 3]，鼻病毒/肠病毒[ n = 1]，CoV-229E [ n = 2]，CoV-NL63 [ n = 2]和CoV-OC43 [ n= 2]）；然而，EIA的总体特异性还是很好的（92％至100％；除一项分析外，其他所有方法的特异性都超过95％）。发病后21天以上，POCT的敏感性为0％至100％，特异性范围为96％至100％。但是，许多POCT具有模糊的条带，并且通常难以解释。血清学检测可以在症状发作后的10天之内检测到SARS-CoV-2抗体。血清学检测的灵敏度根据标记物（IgA / IgM与IgG对总抗体）和制造商的不同而有所不同。但是，总体而言，仅4个EIA和4个POCT在症状发作后21天的敏感性> 95％。与其他季节性冠状病毒的交叉反应性值得关注。