Clinical validation of point-of-care SARS-COV-2 BD Veritor antigen test by a single throat swab for rapid COVID-19 status on hospital patients predominantly without overt COVID symptoms

Bonde, J.; Ejegod, D. M.; Pedersen, H.; Smith, B.; Cortes, D.; Leding, C.; Thomsen, T.; Benfield, T.; Schnieder, U. V.; Tingleff, J.; Arbyn, M.; Lisby, G.; Andersen, O.

BACKGROUND Fast identification of severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) infected individuals is a strategically vital task to ensure correct management and quarantine. Rapid antigen test could be a supplement to the standard-of-care Nucleic Acid Amplification Test (NAAT). The aim of this study was to determine the accuracy of the BD Veritor SARS-CoV-2 antigen test as a screening instrument in a hospital setting. METHODS A cohort of prospective samples were collected from hospital staff and patients at the Emergency, Infectious Diseases and Pediatrics and Adolescent Medicine departments at Hvidovre Hospital. All samples were collected using oropharyngeal swabs, and BD Veritor Antigen test results were paired with routine NAAT test results. Sensitivity, specificity, positive and negative predictive values of the antigen test were calculated using NAAT as reference. RESULTS Overall, 809 samples from 674 individuals were included (average age 45 years, range 0-98 years). Among all samples, 8% were SARS-CoV-2 positive by NAAT testing and 5.3% by BD Veritor. The sensitivity of the antigen test was 63.1% and specificity 99.7%. The positive predictive value was 95.3%. False-positive rate was 4%. The cycle threshold value was significantly higher among individuals with false negative antigen tests compared to true positives. CONCLUSION The sensitivity, specificity and positive predictive values show that the BD Veritor antigen test from oropharyngeal collected specimens performs well. Antigen testing may be a supplement, but not substitute, to NAAT testing as the primary diagnostic modality in hospital settings where fast turnaround test results may assist in decisions regarding isolation and quarantine.