Assessment of twenty-two SARS-CoV-2 rapid antigen tests against SARS-CoV-2: A laboratory evaluation study

ABSTRACT

BackgroundRapid antigen testing is widely used as a way of scaling up population-level testing. To better inform antigen test deployment in Australia, we evaluated 22 commercially available antigen tests against the currently circulating delta variant, including an assessment of culture infectivity. MethodsAnalytical sensitivity was evaluated against SARS-CoV-2 B.1.617.2 (Delta), reported as TCID50/mL, cycle threshold (Ct) and viral load (RNA copies/mL). Specificity was assessed against non-SARS-CoV-2 viruses. Clinical sensitivity and correlation with cell culture infectivity was assessed using the Abbott PanBio COVID-19 Ag test. ResultsNineteen kits consistently detected SARS-CoV-2 antigen equivalent to 1.3 x 106 copies/mL (5.8 x 103 TCID50 /mL). Specificity for all kits was 100%. Compared to RT-PCR the Abbott PanBio COVID-19 Ag test was 52.6% (95% CI, 41.6% to 63.3%) concordant, with a 50% detection probability for infectious cell culture at 5.9 log10 RNA copies/mL (95% CI, 5.3 to 6.5 log10 copies/mL). Antigen test concordance was 97.6% (95% CI, 86.3% to 100.0%) compared to cell culture positivity. ConclusionsAntigen test positivity correlated with positive viral culture, suggesting antigen test results may determine SARS-CoV-2 transmission risk. Analytical sensitivity varied considerably between kits highlighting the need for ongoing systematic post-market evaluation to inform test selection and deployment.