Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV-2 Antibodies.
Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV-2 Antibodies.
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DOI：
10.1128/jcm.01361-20
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发表时间：
2020-09-22
影响因子：
9.4
通讯作者：
Tipples G
中科院分区：
文献类型：
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作者：
Charlton CL;Kanji JN;Johal K;Bailey A;Plitt SS;MacDonald C;Kunst A;Buss E;Burnes LE;Fonseca K;Berenger BM;Schnabl K;Hu J;Stokes W;Zelyas N;Tipples G
冠状病毒病（COVID）血清学检测对于确定人群的总体血清阳性率和促进该人群的暴露估计至关重要。我们对酶免疫测定法（EIA）和床旁侧流测定法（POCT）进行了头对头评估，以检测严重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6种EIA（Abbott、Affinity、Bio-Rad、DiaSorin、Euroimmun和Roche）和6种POCT（BTNX、Biolidics、Deep Blue、Genrui、Getein BioTech和Innovita）在已知COVID-19感染个体中检测SARS-CoV-2抗体的能力进行了评价。冠状病毒病（COVID）血清学检测对于确定人群的总体血清阳性率和促进该人群的暴露估计至关重要。我们对酶免疫测定法（EIA）和床旁侧流测定法（POCT）进行了头对头评估，以检测严重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6种EIA（Abbott、Affinity、Bio-Rad、DiaSorin、Euroimmun和Roche）和6种POCT（BTNX、Biolidics、Deep Blue、Genrui、Getein BioTech和Innovita）在已知COVID-19感染个体中检测SARS-CoV-2抗体的能力进行了评价。EIA的灵敏度范围为50%至100%，只有四种测定在症状发作后21天后具有>95%的总体灵敏度。与其他呼吸道病毒的交叉反应性（副流感病毒[PIV-4] [n = 5]、人偏肺病毒[hMPV] [n = 3]、鼻病毒/肠道病毒[n = 1]、CoV-229 E [n = 2]、CoV-NL 63 [n = 2]和CoV-OC 43 [n = 2]）;然而，EIA的总体特异性良好（92 - 100%;除一项试验外，所有试验的特异性均高于95%）。POCT在发病后>21天的敏感性为0至100%，特异性范围为96至100%。然而，许多POCT有微弱的条带，往往难以解释。血清学检测最早可在症状出现后10天检测到SARS-CoV-2抗体。血清学测定的灵敏度基于标记物（伊加/IgM对比IgG对比总的）和制造商而变化;然而，总体而言，在症状发作后21天，仅4种EIA和4种POCT具有>95%的灵敏度。与其他季节性冠状病毒的交叉反应令人担忧。血清学检测不应用于急性感染的诊断，而应用于精心设计的血清学调查，以促进对人群血清阳性率的了解，并确定先前对SARS-CoV-2的暴露。
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. 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.