Comparative Performance of Five Commercially Available Serologic Assays To Detect Antibodies to SARS-CoV-2 and Identify Individuals with High Neutralizing Titers.
Comparative Performance of Five Commercially Available Serologic Assays To Detect Antibodies to SARS-CoV-2 and Identify Individuals with High Neutralizing Titers.
复制标题
五个可获得五种可获得SARS-COV-2抗体并鉴定具有高中和滴度的个体的抗体的比较性能。
DOI：
10.1128/jcm.02257-20
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发表时间：
2021-01-21
影响因子：
9.4
通讯作者：
Laeyendecker O
中科院分区：
文献类型：
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作者：
Patel EU;Bloch EM;Clarke W;Hsieh YH;Boon D;Eby Y;Fernandez RE;Baker OR;Keruly M;Kirby CS;Klock E;Littlefield K;Miller J;Schmidt HA;Sullivan P;Piwowar-Manning E;Shrestha R;Redd AD;Rothman RE;Sullivan D;Shoham S;Casadevall A;Quinn TC;Pekosz A;Tobian AAR;Laeyendecker O
需要准确的血清学检测SARS-CoV-2抗体，以表征SARS-CoV-2感染的流行病学特征，并确定2019年冠状病毒病（COVID-19）恢复期血浆（CCP）捐献的潜在候选者。本研究比较了商用酶免疫测定法（EIAs）在检测SARS-CoV-2 IgG或总抗体和中和抗体（nab）方面的性能。使用先前有SARS-CoV-2感染分子确认的潜在CCP供体（n = 214）和大流行前急诊科未感染SARS-CoV-2的患者（n = 1,099）的横断面样本，评估了5种市售EIAs（雅培、euroimmunen、EDI、免疫诊断和罗氏）检测SARS-CoV-2 IgG或总抗体的诊断准确性。需要准确的血清学检测SARS-CoV-2抗体，以表征SARS-CoV-2感染的流行病学特征，并确定2019年冠状病毒病（COVID-19）恢复期血浆（CCP）捐献的潜在候选者。本研究比较了商用酶免疫测定法（EIAs）在检测SARS-CoV-2 IgG或总抗体和中和抗体（nab）方面的性能。使用先前有SARS-CoV-2感染分子确认的潜在CCP供体（n = 214）和大流行前急诊科未感染SARS-CoV-2的患者（n = 1,099）的横断面样本，评估了5种市售EIAs（雅培、euroimmunen、EDI、免疫诊断和罗氏）检测SARS-CoV-2 IgG或总抗体的诊断准确性。在214名潜在CCP供体中，所有人都是在症状出现后14天内取样的，只有少数（n = 16[7.5%]）因COVID-19住院；140名潜在CCP供体通过所有5种eia和微量中和试验进行了检测。按照生产厂家方案检测SARS-CoV-2 IgG或总抗体，各单项EIA的灵敏度为76.4% ~ 93.9%，特异性为87.0% ~ 99.6%。以≥160的nAb滴度临界值作为阳性检测结果的参考（n = 140个CCP供者），每个EIA的接受者工作曲线下的经验面积范围为0.66（罗氏）至0.90（欧免疫）。商用eia检测SARS-CoV-2抗体的诊断准确度高，但检测高nAb滴度的诊断准确度不一定高。一些但不是所有的商业环境影响评价可用于鉴定恢复期个体中nAb滴度高的个体。
Accurate serological assays to detect antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to characterize the epidemiology of SARS-CoV-2 infection and identify potential candidates for coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) donation. This study compared the performances of commercial enzyme immunoassays (EIAs) with respect to detection of IgG or total antibodies to SARS-CoV-2 and neutralizing antibodies (nAbs). The diagnostic accuracy of five commercially available EIAs (Abbott, Euroimmun, EDI, ImmunoDiagnostics, and Roche) for detection of IgG or total antibodies to SARS-CoV-2 was evaluated using cross-sectional samples from potential CCP donors who had prior molecular confirmation of SARS-CoV-2 infection (n = 214) and samples from prepandemic emergency department patients without SARS-CoV-2 infection (n = 1,099). Accurate serological assays to detect antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to characterize the epidemiology of SARS-CoV-2 infection and identify potential candidates for coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) donation. This study compared the performances of commercial enzyme immunoassays (EIAs) with respect to detection of IgG or total antibodies to SARS-CoV-2 and neutralizing antibodies (nAbs). The diagnostic accuracy of five commercially available EIAs (Abbott, Euroimmun, EDI, ImmunoDiagnostics, and Roche) for detection of IgG or total antibodies to SARS-CoV-2 was evaluated using cross-sectional samples from potential CCP donors who had prior molecular confirmation of SARS-CoV-2 infection (n = 214) and samples from prepandemic emergency department patients without SARS-CoV-2 infection (n = 1,099). Of the 214 potential CCP donors, all were sampled >14 days since symptom onset and only a minority (n = 16 [7.5%]) had been hospitalized due to COVID-19; 140 potential CCP donors were tested by all five EIAs and a microneutralization assay. Performed according to the protocols of the manufacturers to detect IgG or total antibodies to SARS-CoV-2, the sensitivity of each EIA ranged from 76.4% to 93.9%, and the specificity of each EIA ranged from 87.0% to 99.6%. Using a nAb titer cutoff value of ≥160 as the reference representing a positive test result (n = 140 CCP donors), the empirical area under the receiver operating curve for each EIA ranged from 0.66 (Roche) to 0.90 (Euroimmun). Commercial EIAs with high diagnostic accuracy to detect SARS-CoV-2 antibodies did not necessarily have high diagnostic accuracy to detect high nAb titers. Some but not all commercial EIAs may be useful in the identification of individuals with high nAb titers among convalescent individuals.