Published December 20, 2021 | Version v1
Journal article Open

Diagnostic Performance of a Rapid Antigen Test Compared with the Reverse Transcription Polymerase Chain Reaction for SARS-CoV-2 Detection in Asymptomatic Individuals Referring to a Drive-in Testing Facility

  • 1. Casa di Cura Salus, Policlinico Triestino SpA, 34123 Trieste, Italy
  • 2. International Centre for Genetic Engineering and Biotechnology (ICGEB), 34149 Trieste, Italy
  • 3. Jiangsu Bioperfectus Technology Co., Ltd., Taizhou 225300, China
  • 4. IFOM, The FIRC Institute of Molecular Oncology, 20139 Milan, Italy

Description

Quick and reliable identification of severe acute respiratory syndrome coronavirus SARS-CoV-2 in the population is required to manage the COVID-19 pandemic. This is a prospective observational study of diagnostic accuracy. Paired swab samples from 317 asymptomatic individuals referring to a drive-in testing facility were tested in parallel by means of the rapid antigen test developed by Jiangsu Bioperfectus Technologies and routine nucleic acid detection. Overall specificity was 100% and sensitivity was 49% but reached 87% at higher viral loads (Ct < 25). In this study, the antigen detection test showed high specificity and good sensitivity in asymptomatic individuals carrying higher viral loads. The assay performance worsened with lower viral loads, making it useful when a rapidly deployable test is essential and to assess a potential risk of immediate transmission in the community, but not recommended for testing asymptomatic individuals.

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