Clinical Microbiology and Infectious Diseases, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
Sci Rep. 2020 Nov 16;10(1):19893. doi: 10.1038/s41598-020-76914-5.
We assessed the performance of Abbott's SARS-CoV-2 IgG assay and the Panbio COVID-19 IgG/IgM rapid test device for the diagnosis of either active or cured COVID-19. Three cohorts of patients were chosen. Cohort 1, patients (n = 65) who attended the emergency department on March 30, 2020 with clinical suspicion of active COVID-19 (n = 56 with proven/probable COVID-19). Cohort 2, hospital workers (n = 92) who had either been (n = 40) or not (n = 52) diagnosed with proven/probable COVID-19 and were asymptomatic at the time of the sampling. Cohort 3, patients (n = 38) cared at the hospital before the start of the COVID-19 pandemic. Detection of serum antibodies was done using Abbott´s SARS-CoV-2 IgG assay and the Panbio COVID-19 IgG/IgM device. Both methods showed 98% agreement for IgG detection. No antibodies were detected in the 38 samples from hospitalized pre-COVID subjects. The diagnostic performance of IgGs detected by Abbott´s SARS-CoV-2 assay in Cohorts 1/2 was: sensitivity (60.7%/75%) and specificity (100%/84.6%). The diagnostic performance of IgM by Panbio COVID-19 in Cohorts 1/2 was: sensitivity (16%/17.5%) and specificity (100%/98.1%). We show that IgG detection alone is insufficient for the diagnosis of active or cured COVID-19. IgM detection has a limited diagnostic value.
我们评估了雅培 SARS-CoV-2 IgG 检测试剂盒和 Panbio COVID-19 IgG/IgM 快速检测设备对现症或既往 COVID-19 的诊断性能。选择了三批患者。队列 1：2020 年 3 月 30 日因临床疑似现症 COVID-19 而就诊于急诊科的患者（56 例确诊/可能 COVID-19）；队列 2：在采样时无症状且要么已确诊（40 例）要么未确诊（52 例）的医院工作人员；队列 3：在 COVID-19 大流行开始前在医院接受治疗的患者。使用雅培 SARS-CoV-2 IgG 检测试剂盒和 Panbio COVID-19 IgG/IgM 设备检测血清抗体。两种方法检测 IgG 的一致性为 98%。38 例 COVID-19 大流行前住院患者的样本中均未检测到抗体。雅培 SARS-CoV-2 检测试剂盒在队列 1/2 中检测 IgG 的诊断性能为：敏感性（60.7%/75%）和特异性（100%/84.6%）。Panbio COVID-19 在队列 1/2 中检测 IgM 的诊断性能为：敏感性（16%/17.5%）和特异性（100%/98.1%）。我们表明，单独检测 IgG 不足以诊断现症或既往 COVID-19。IgM 检测的诊断价值有限。
