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. 2021 Apr:137:104789.
doi: 10.1016/j.jcv.2021.104789. Epub 2021 Mar 10.

Diagnostic performance of a SARS-CoV-2 rapid antigen test in a large, Norwegian cohort

Elisabeth Toverud Landaas  1 , Margrethe Larsdatter Storm  2 , Mette Christophersen Tollånes  3 , Regine Barlinn  4 , Anne-Marte Bakken Kran  2 , Karoline Bragstad  2 , Andreas Christensen  5 , Trude Andreassen  6
Affiliations

Diagnostic performance of a SARS-CoV-2 rapid antigen test in a large, Norwegian cohort

Elisabeth Toverud Landaas et al. J Clin Virol. 2021 Apr.

Abstract

Background: Rapid antigen tests (RATs) may be included in national strategies for handling the SARS-CoV-2 pandemic, as they provide test results rapidly, are easily performed outside laboratories, and enable immediate contract tracing. However, before implementation further clinical evaluation of test sensitivity is warranted.

Objectives: To examine the performance of Abbott's Panbio™ COVID-19 Ag Rapid Test Device for SARS-CoV-2 testing in a low to medium prevalence setting in Norway.

Study design: A prospective study comparing the results of the Panbio RAT with PCR in 4857 parallel samples collected at a SARS-CoV-2 test station in Oslo, and from COVID-19 outbreaks in six Norwegian municipalities.

Results: A total of 4857 cases were included in the study; 3991 and 866 cases from the test station and the outbreak municipalities, respectively. The prevalence at the test station in Oslo was 6.3 %, and the overall sensitivity of the RAT was 74 %. Increased sensitivity was observed in patients who experienced symptoms (79 %) and when considering samples with viral loads above estimated level of infectivity (84 %), while it was lower in asymptomatic persons (55 %). In the outbreak municipalities, the overall prevalence was 6.9 %, and the total sensitivity of the RAT was 70 %.

Conclusions: Our results indicate that the test correctly identified most infectious individuals. Nevertheless, the sensitivity is considerably lower than for PCR, and it is important that the limitations of the test are kept in mind in the follow-up of tested individuals.

Keywords: COVID-19; Coronavirus; Lateral flow assay (LFA); Point-of-care test (POCT); Rapid antigen test (RAT); SARS-CoV-2.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Positive predictive value (PPV) and negative predictive value (NPV) at different prevalence rates of SARS-CoV-2, given a sensitivity of 74.4 % and a specificity of 99.9 %.
Fig. 2
Fig. 2
Distribution of ct values from the SARS-CoV-2 PCR in RAT negative and positive cases.
See this image and copyright information in PMC

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