INTRODUCTION: Fast and accurate detection of SARS-CoV-2 is essential in limiting the COVID-19 pandemic. Rapid antigen (AG) tests provide results within minutes; however, their accuracy has been questioned. The study aims to determine the accuracy and cost of the STANDARD Q COVID-19 AG test compared with RT-PCR.

METHODS: Individuals 18 years or older with an appointment for a RT-PCR test on 26-31 December 2020 at a public test centre in Copenhagen, Denmark were invited to participate. An oropharyngeal swab was collected for RT-PCR analysis, followed by a nasopharyngeal swab examined by the AG test (SD Biosensor). The diagnostic accuracy of the AG test was calculated with RT-PCR as reference. Costs were evaluated for both tests.

RESULTS: A total of 4,811 paired conclusive test results were collected (median age: 45 years, female: 53%). The RT-PCR test revealed 221 (4.6%) positive tests. The overall sensitivity and specificity of the AG test were 69.7% and 99.5%, respectively. Viral cycle threshold values were significantly higher in individuals with false negative AG tests than in individuals who were true positives. The RT-PCR test and AG test costs were 67.0 DKK (10.8 USD) and 35.0 DKK (5.7 USD), respectively, per positive case detected at 100,000 daily tests.

CONCLUSIONS: The AG test enables mass testing and provides immediate results, which is important in SARS-CoV-2 screening. The AG test is a good and relevant supplement to RT-PCR testing in public SARS-CoV-2 screenings.

FUNDING: This project received no external funding. Copenhagen Medical A/S delivering the rapid AG tests and provided test personnel but were not otherwise involved.

TRIAL REGISTRATION: Clinicaltrials.org: NCT04716088.