• Johan Nordgren, Sumit Sharma, Henrik Olsson, Mikael Jämtberg, Tina Falkeborn, Lennart Svensson, and Marie Hagbom.
• Division of Molecular Medicine and Virology, Department of Biomedical and Clinical Sciences, Linköping University, 581 85 Linköping, Sweden.
• J. Clin. Virol. 2021 Jul 1; 140: 104846.

BackgroundThe COVID-19 pandemic has highlighted the need for rapid, cost effective and easy-to-use diagnostic tools for SARS-CoV-2 infections that can be used in point of care settings to limit disease transmission.ObjectiveWe evaluated two rapid antigen immunochromatographic tests, Abbott Panbio™ COVID-19 Ag Rapid Test (Panbio) and Zhejiang Orient Gene/Healgen Biotech Coronavirus Ag rapid test cassette (Orient gene) for detection of infectious SARS-CoV-2.ResultsThe tests were evaluated on nasopharyngeal samples taken from individuals having respiratory and/or COVID-19 related symptoms, which had been analyzed for SARS-CoV-2 RNA using real-time PCR. In total 156 PCR-positive, and 130 (Panbio) and 176 (Orient Gene) PCR-negative samples were analyzed. Overall sensitivity and specificity were 71.8% and 100% for Panbio and 79.5% and 74.4% for the Orient Gene test respectively. The false positives by the Orient Gene test were verified as SARS-CoV-2 negative by in-house real-time PCR assay and were negative for the four seasonal coronaviruses. Subgroup analysis revealed that the antigen tests had high sensitivity for samples with Ct-values <25 (>88%) and for samples containing infectious viruses as determined by cultivation on Vero cells, 94.1% and 97.1% for the Panbio and Orient gene tests, respectively. Furthermore, both tests had a sensitivity of <50 picogram for nucleocapsid protein. No sample with a Ct-value >27 was shown to contain infectious virus.ConclusionThe results indicate that the rapid antigen tests, especially the Panbio tests may be a valuable tool to detect contagious persons during the ongoing pandemic.Copyright © 2021. Published by Elsevier B.V.

This article appears in the collection: Does a COVID RAT-negative result mean non-infectious?.

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