Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres

ObjectivesTo our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at point care (POC). We evaluated Panbio™ COVID-19 Ag Rapid Test Device for diagnosis coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres.MethodsRAD was performed immediately after sampling following manufacturer's instructions (reading 15 min). RT-PCRs were carried out within 24 h specimen collection. Samples displaying discordant results processed culture Vero E6 cells. Presence severe acute respiratory syndrome 2 (SARS-CoV-2) cell cultures confirmed by RT-PCR.ResultsOut 412 patients, 43 (10.4%) tested positive RT-PCR and RAD, 358 (86.9%) negative both methods; (RT-PCR+/RAD–) obtained 11 (2.7%). Overall specificity sensitivity detection 100% (95%CI 98.7–100%) 79.6% 67.0–88.8%), respectively, taking as reference. RAD predictive value an estimated prevalence 5% 10% 99% 97.4–99.6%) 97.9% 95.9–98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD– 11).ConclusionThe well POC test early centres. More crucially, data suggested that with RT-PCR-proven testing are unlikely to infectious.