Clinical assessment of the Roche SARS-CoV-2 rapid antigen test

Diagnosis (Berl). 2021 Jan 18;8(3):322-326. doi: 10.1515/dx-2020-0154. Print 2021 Aug 26.


Objectives: Novel point-of-care antigen assays present a promising opportunity for rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The purpose of this study was the clinical assessment of the new Roche SARS-CoV-2 Rapid Antigen Test.

Methods: The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test was evaluated vs. a reverse transcription polymerase chain reaction (RT-PCR) laboratory-based assay (Seegene AllplexTM2019-nCoV) in nasopharyngeal swabs collected from a series of consecutive patients referred for SARS-CoV-2 diagnostics to the Pederzoli Hospital (Peschiera del Garda, Verona, Italy) over a 2-week period.

Results: The final study population consisted of 321 consecutive patients (mean age, 46 years and IQR, 32-56 years; 181 women, 56.4%), with 149/321 (46.4%) positive for SARS-CoV-2 RNA via the Seegene AllplexTM2019-nCoV Assay, and 109/321 (34.0%) positive with Roche SARS-CoV-2 Rapid Antigen Test, respectively. The overall accuracy of Roche SARS-CoV-2 Rapid Antigen Test compared to molecular testing was 86.9%, with 72.5% sensitivity and 99.4% specificity. Progressive decline in performance was observed as cycle threshold (Ct) values of different SARS-CoV-2 gene targets increased. The sensitivity was found to range between 97-100% in clinical samples with Ct values <25, between 50-81% in those with Ct values between 25 and <30, but low as 12-18% in samples with Ct values between 30 and <37.

Conclusions: The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test is excellent in nasopharyngeal swabs with Ct values <25, which makes it a reliable screening test in patients with high viral load. However, mass community screening would require the use of more sensitive techniques.

Keywords: COVID-19; SARS-CoV-2; antigen; diagnosis; immunoassay.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Antigens, Viral / analysis*
  • Antigens, Viral / immunology
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 / virology*
  • COVID-19 Nucleic Acid Testing / standards
  • COVID-19 Serological Testing / standards*
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques / standards*
  • Nasopharynx / immunology
  • Nasopharynx / virology
  • Point-of-Care Systems
  • SARS-CoV-2 / immunology*
  • SARS-CoV-2 / isolation & purification*
  • Sensitivity and Specificity
  • Viral Load


  • Antigens, Viral