Abstract

BackgroundRapid 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.ObjectivesTo 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 designA 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.ResultsA 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 %.ConclusionsOur 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.

Highlights

  • The Norwegian strategy to fight the spread of severe acute respira­ tory syndrome coronavirus 2 (SARS-CoV-2) is reliant upon rapid iden­ tification of infected individuals, isolation of cases, contact tracing and quarantine

  • Testing was performed following the same procedure as Aker test station, except that the first swab was sent to the local microbiology laboratory instead of to Oslo University Hospital (OUH)

  • We assessed the performance of the Panbio Rapid antigen tests (RATs) for SARS-CoV-2 compared to polymerase chain reaction (PCR) in 4857 parallel samples

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Summary

Introduction

The Norwegian strategy to fight the spread of severe acute respira­ tory syndrome coronavirus 2 (SARS-CoV-2) is reliant upon rapid iden­ tification of infected individuals, isolation of cases, contact tracing and quarantine In this respect, SARS-CoV-2 rapid antigen tests (RATs) could represent a good alternative to polymerase chain reaction (PCR) given its short turnaround time, which enables earlier initiation of isolation and infection control measurements. The aim of the evaluation was to study the RAT’s performance compared to SARS-CoV-2 PCR in 1) a low to medium prevalence setting at the COVID-19 test station Aker in Oslo, and 2) in outbreaks in more rural areas. 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. 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

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