AZ Delta Medical Laboratories, AZ Delta General Hospital, Roeselare, Belgium.
VUB Metabolomics Platform, Brussels Free University, Brussels, Belgium.
Am J Clin Pathol. 2020 Oct 13;154(5):610-619. doi: 10.1093/ajcp/aqaa140.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology tests are clinically useful to document prior SARS-CoV-2 infections. Data are urgently needed to select assays with optimal sensitivity at acceptable specificity for antibody detection.
A comparative evaluation was performed of 7 commercial SARS-CoV-2 serology assays on 171 sera from 135 subjects with polymerase chain reaction-confirmed SARS-CoV-2 infection (71 hospitalized patients and 64 paucisymptomatic individuals). Kinetics of IgA/IgM/IgG seroconversion to viral N and S protein epitopes were studied from 0 to 54 days after onset of symptoms. Cross-reactivity was verified on 57 prepandemic samples.
Wantai SARS-COV-2 Ab ELISA and Orient Gene COVID-19 IgG/IgM Rapid Test showed superior overall sensitivity for detection of SARS-CoV-2 antibodies. Elecsys Anti-SARS-CoV-2 assay and EUROIMMUN Anti-SARS-CoV-2 combined IgG/IgA showed acceptable sensitivity (>95%) vs the consensus result of all assays from 10 days post onset of symptoms. Wantai SARS-COV-2 Ab ELISA, Elecsys Anti-SARS-CoV-2 assay, and Innovita 2019-nCoV Ab rapid test showed least cross-reactivity, resulting in an optimal analytical specificity greater than 98%.
Wantai SARS-COV-2 Ab ELISA and Elecsys Anti-SARS-CoV-2 assays are suitable for sensitive and specific detection of SARS-CoV-2 antibodies from 10 days after onset of symptoms.
严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)血清学检测可用于记录既往 SARS-CoV-2 感染。迫切需要选择具有最佳敏感性和可接受特异性的检测方法来检测抗体。
对 135 例经聚合酶链反应(PCR)确诊的 SARS-CoV-2 感染患者(71 例住院患者和 64 例症状较轻的患者)的 171 份血清进行了 7 种商业 SARS-CoV-2 血清学检测的比较评估。从症状出现后 0 至 54 天,研究了 IgA/IgM/IgG 对病毒 N 和 S 蛋白表位的血清转换动力学。在 57 份大流行前样本中验证了交叉反应性。
万泰 SARS-CoV-2 Ab ELISA 和东方基因 COVID-19 IgG/IgM 快速检测对 SARS-CoV-2 抗体的检测具有较高的总体敏感性。Elecsys Anti-SARS-CoV-2 检测和 EUROIMMUN Anti-SARS-CoV-2 联合 IgG/IgA 从症状出现后 10 天起对所有检测方法的共识结果具有可接受的敏感性(>95%)。万泰 SARS-CoV-2 Ab ELISA、Elecsys Anti-SARS-CoV-2 检测和 Innovita 2019-nCoV Ab 快速检测的交叉反应性最小,分析特异性大于 98%。
万泰 SARS-CoV-2 Ab ELISA 和 Elecsys Anti-SARS-CoV-2 检测可从症状出现后 10 天起用于敏感和特异性检测 SARS-CoV-2 抗体。