Real-life validation of the Panbio COVID-19 Antigen Rapid Test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection

ABSTRACT

BackgroundRT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 minutes and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined. MethodsThe diagnostic value of the Panbio COVID-19 Ag Rapid Test (Abbott), was determined in comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs. Findings1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% (n=139) and 30.3% (n=63) in Utrecht and Aruba respectively. Specificity of the Panbio COVID-19 Ag Rapid Test was 100% (95%CI 99.7-100%) in both settings. Test sensitivity was 72.6% (95%CI 64.5-79.9%) in the Netherlands and 81.0% (95% CI 69.0-89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI 89.3-98.5%) in the Netherlands and 98.0% (95%CI 89.2-99.95%) in Aruba. InterpretationIn community-dwelling subjects with mild respiratory symptoms the Panbio COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2. FundingUMCU and LABHOH, Aruba