A comparative evaluation between the Abbott Panbio™ COVID-19 IgG/IgM rapid test device and Abbott Architect™ SARS CoV-2 IgG assay

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.