A comparative evaluation between the Abbott Panbio™ COVID-19 IgG/IgM rapid test device and Abbott Architect™ SARS CoV-2 IgG assay
A comparative evaluation between the Abbott Panbio™ COVID-19 IgG/IgM rapid test device and Abbott Architect™ SARS CoV-2 IgG assay
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DOI：
10.1016/j.jcv.2020.104645
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发表时间：
2020-11-01
影响因子：
8.8
通讯作者：
Cloherty, Gavin
中科院分区：
文献类型：
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作者：
Batra, Rahul;Olivieri, Luis Gonzalez;Cloherty, Gavin
简介：SARS-CoV-2 抗体可作为关键诊断标记物，用于确定 COVID-19 大流行的传播范围、确认患者康复情况、监测感染的潜在长期影响以及评估防止再次感染的潜在保护作用。随着新的抗体测试的出现，评估其性能和效用非常重要。本研究的目的是比较 Abbott Panbio (TM) COVID-19 IgG/IgM 快速检测装置与 Abbott Architect (TM) SARS CoV-2 IgG Assay 在检测 COVID-19 IgG 抗体方面的性能。方法：使用两组样本来挑战这两项抗体测试：(1) 一组 2014 年收集的 150 份大流行前阴性样本，(2) 一组来自美国和英国 87 名住院 COVID-19 患者的 122 份标本被确认为 SARS-CoV-2 RNA 检测结果呈阳性。结果：对于症状出现后 14 天以上或 RNA 检测后 5 天以上收集的标本，在排除或包括免疫功能低下患者时，Architect (TM) 检测的特异性为 100%，敏感性为 99.1% 和 93.9%。 PanbioTM 测试与 ArchitectTM 的一致性为 99.3%。值得注意的是，N = 6 名免疫受损个体在第 30 天时并未产生可检测到的抗体。结论：Architect (TM) SARS CoV-2 IgG Assay 和 Panbio (TM) COVID-19 IgG/IgM 快速检测装置在检测 SARS CoV-2 IgG 方面具有良好的一致性。
Introduction: Antibodies to SARS-CoV-2 serve as critical diagnostic markers for determining how broadly the COVID-19 pandemic has spread, confirming patient recovery, monitoring potential long-term effects of infection, and evaluating potential protection from reinfection. As new antibody tests become available, it is important to evaluate their performance and utility. The aim of this study was to compare the performance of the Abbott Panbio (TM) COVID-19 IgG/IgM Rapid Test Device against the Abbott Architect (TM) SARS CoV-2 IgG Assay for the detection of the COVID-19 IgG antibody.Methods: Two panels of specimens were utilized to challenge both antibody tests: (1) a set of 150 prepandemic negative specimens collected in 2014, and (2) a set of 122 specimens from 87 hospitalized COVID-19 patients in the US and UK that were confirmed with a positive SARS-CoV-2 RNA test result.Results: The Architect (TM) test had a specificity of 100 % and sensitivity of 99.1 % and 93.9 % when excluding or including immunocompromised patients, respectively for specimens collected >14 days post symptom onset or >5 days post-RNA testing. The PanbioTM test had 99.3 % agreement to ArchitectTM. Notably, N = 6 immune-compromised individuals were identified that did not develop detectable antibodies by day 30.Conclusion: There is good concordance between the Architect (TM) SARS CoV-2 IgG Assay and Panbio (TM) COVID-19 IgG/IgM Rapid Test Device for the detection of SARS CoV-2 IgG.