Diagnostic performance of rapid antigen tests (RATs) for SARS-CoV-2 and their efficacy in monitoring the infectiousness of COVID-19 patients

Sci Rep. 2021 Nov 24;11(1):22863. doi: 10.1038/s41598-021-02197-z.

Abstract

The most widely used test for the diagnosis of SARS-CoV-2 infection is a PCR test. PCR has very high sensitivity and is able to detect very low amounts of RNA. However, many individuals receiving a positive test result in a context of a PCR-based surveillance might be infected with SARS-CoV-2, but they are not contagious at the time of the test. The question arises regards if the cost effective, portable rapid antigen tests (RATs) have a better performance than PCR in identification of infectious individuals. In this direction, we examined the diagnostic performance of RATs from 14 different manufacturers in 400 clinical samples with known rRT-PCR cycles threshold (cT) and 50 control samples. Substantial variability was observed in the limit of detection (LOD) of different RATs (cT = 26.8-34.7). The fluorescence-based RAT exhibited a LOD of cT = 34.7. The use of the most effective RATs leads to true positive rates (sensitivities) of 99.1% and 90.9% for samples with cT ≤ 30 and cT ≤ 33, respectively, percentages that can guarantee a sensitivity high enough to identify contagious patients. RAT testing may also substantially reduce the quarantine period for infected individuals without compromising personal or public safety.

MeSH terms

  • Antigens, Viral / analysis
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 Serological Testing / methods*
  • Diagnostic Tests, Routine
  • Humans
  • Immunologic Tests
  • Limit of Detection
  • Nucleic Acid Amplification Techniques
  • SARS-CoV-2 / immunology*
  • SARS-CoV-2 / pathogenicity
  • Sensitivity and Specificity

Substances

  • Antigens, Viral