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SARS-CoV-2 rapid antigen test: High sensitivity to detect infectious virus

  • Nordgren, Johan1
  • Sharma, Sumit1
  • Olsson, Henrik2
  • Jämtberg, Mikael2
  • Falkeborn, Tina3
  • Svensson, Lennart1, 4
  • Hagbom, Marie1
  • 1 s, Linköping University, 581 85 Linköping, Sweden
  • 2 Noviral Sweden AB, Västmannagatan 3, 111 24 Stockholm, Sweden
  • 3 Division of Clinical Microbiology, Linköping University Hospital, 581 85 Linköping, Sweden
  • 4 Division of Infectious Diseases, Department of Medicine Solna, Karolinska Institute, 171 76 Stockholm, Sweden
Published Article
Journal of Clinical Virology
Published by Elsevier B.V.
Publication Date
Apr 24, 2021
DOI: 10.1016/j.jcv.2021.104846
PMID: 33971580
PMCID: PMC8105081
PubMed Central
  • Article


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 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. 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.

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