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SARS-CoV-2 rapid antigen test: High sensitivity to detect infectious virus
Linköping University, Department of Biomedical and Clinical Sciences, Division of Molecular Medicine and Virology. Linköping University, Faculty of Medicine and Health Sciences.ORCID iD: 0000-0002-5349-2569
Linköping University, Department of Biomedical and Clinical Sciences, Division of Molecular Medicine and Virology. Linköping University, Faculty of Medicine and Health Sciences.
Noviral Sweden AB, Sweden.
Noviral Sweden AB, Sweden.
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2021 (English)In: Journal of Clinical Virology, ISSN 1386-6532, E-ISSN 1873-5967, Vol. 140, article id 104846Article in journal (Refereed) Published
Abstract [en]

Background: The 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. Objective: We evaluated two rapid antigen immunochromatographic tests, Abbott PanbioTM 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. Results: The 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. Conclusion: The results indicate that the rapid antigen tests, especially the Panbio tests may be a valuable tool to detect contagious persons during the ongoing pandemic.

Place, publisher, year, edition, pages
ELSEVIER , 2021. Vol. 140, article id 104846
Keywords [en]
SARS-CoV-2; Rapid antigen test; Infectious virus
National Category
Microbiology in the medical area
Identifiers
URN: urn:nbn:se:liu:diva-177416DOI: 10.1016/j.jcv.2021.104846ISI: 000659514400010PubMedID: 33971580OAI: oai:DiVA.org:liu-177416DiVA, id: diva2:1574731
Note

Funding Agencies|Region Ostergotland [30320005]

Available from: 2021-06-29 Created: 2021-06-29 Last updated: 2024-01-08

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Nordgren, JohanSharma, SumitFalkeborn, TinaSvensson, LennartHagbom, Marie
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