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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 × 106 copies/mL (5.8 × 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.

The precision of vaccine effectiveness (VE) estimates is dependent on sample size and sampling methods. In Victoria, participating general practitioners (GPs) are not limited by the number of influenza-like illness (ILI) patients they collect respiratory samples (swabs) from in sentinel surveillance. However, in the context of scarce resources it is of interest to determine the minimum sample size needed for reliable estimates.Following the test-negative design, patients with ILI were recruited by GPs and tested for influenza. Descriptive analyses were conducted to assess possible selection bias introduced by GPs. VE was calculated by logistic regression as [1 – odds ratio] x 100% and adjusted for week of presentation and age. Random 20% and 50% samples were selected without replacement to estimate the effect of swab rates on VE estimates.GPs swabbed a smaller proportion of patients aged ≥65 years (45.9%, n=238) than those5 (75.6%, n=288), 5–17 (67.9%, n=547) and 18–64 (75.6%, n=2662) years. Decreasing the swab rate did not alter VE point estimates significantly. However, it reduced the precision of estimates and in some instances resulted in too small a sample size to estimate VE.Imposing a 20% or 50% swabbing rate produces less robust VE estimates. The number of swabs required per year to produce precise estimates should be dictated by seasonal severity, rather than an arbitrary rate. It would be beneficial for GPs to swab patients systematically by age group to ensure there are sufficient data to investigate VE against a particular subtype in a given age group.