The sensitivity of SARS-CoV-2 antigen tests in the view of large-scale testing

Abstract

Objectives: Antigen tests have emerged as an alternative to SARS-CoV-2 diagnostic PCR, thought to be valuable especially for the screening of bigger communities. To check appropriateness of the antigen based testing, we determined sensitivity of two point-of-care antigen tests when applied to a cohort of COVID-19 symptomatic, COVID-19 asymptomatic and healthy persons.

Methods: We examined nasopharyngeal swabs with antigen test 1 (Panbio Covid-19 Ag Rapid Test, Abbott) and antigen test 2 (Standard F Covid-19 Ag FIA, SD Biosensor). An additional nasopharyngeal and oropharyngeal swab of the same individual was checked with PCR (Allplex SARS-nCoV-2, Seegene). Within a 4-day period in October 2020, we collected specimens from 591 subjects. Of them, 290 had COVID-19 associated symptoms.

Results: While PCR positivity was detected in 223 cases, antigen test 1 and antigen test 2 were found positive in 148 (sensitivity 0.664, 95%CI 0.599, 0.722) and 141 (sensitivity 0.623, 95%CI 0.558, 0.684) patients, respectively. When only symptomatic patients were analysed, sensitivity increased to 0.738 (95%CI 0.667, 0.799) for the antigen test 1 and to 0.685 (95%CI 0.611, 0.750) for the antigen test 2. The substantial drop in sensitivity to 12.9% (95%CI 0.067, 0.234) was observed for samples with the PCR threshold cycle above > 30.

Conclusions: Low sensitivity of antigen tests leads to the considerable risk of false negativity. It is advisable to implement repeated testing with high enough frequency if the antigen test is used as a frontline screening tool, and to follow with PCR if it is applied to vulnerable populations.

Keywords: SARS-CoV-2; antigen test; false negative rate; false negativity; population-wide screening; sensitivity.