• Eliseo Albert, Ignacio Torres, Felipe Bueno, Dixie Huntley, Estefanía Molla, Miguel Ángel Fernández-Fuentes, Mireia Martínez, Sandrine Poujois, Lorena Forqué, Arantxa Valdivia, Carlos Solano de la Asunción, Josep Ferrer, Javier Colomina, and David Navarro.
• Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
• Clin. Microbiol. Infect. 2021 Mar 1; 27 (3): 472.e7-472.e10.

ObjectivesTo our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at the point of care (POC). We evaluated the Panbio™ COVID-19 Ag Rapid Test Device for diagnosis of coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres.MethodsRAD was performed immediately after sampling following the manufacturer's instructions (reading at 15 min). RT-PCRs were carried out within 24 h of specimen collection. Samples displaying discordant results were processed for culture in Vero E6 cells. Presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures was confirmed by RT-PCR.ResultsOut of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD, and 358 (86.9%) tested negative by both methods; discordant results (RT-PCR+/RAD-) were obtained in 11 patients (2.7%). Overall specificity and sensitivity of rapid antigen detection (RAD) was 100% (95%CI 98.7-100%) and 79.6% (95%CI 67.0-88.8%), respectively, taking RT-PCR as the reference. Overall RAD negative predictive value for an estimated prevalence of 5% and 10% was 99% (95%CI 97.4-99.6%) and 97.9% (95%CI 95.9-98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results (n = 11).ConclusionThe Panbio™ COVID-19 Ag Rapid Test Device performed well as a POC test for early diagnosis of COVID-19 in primary healthcare centres. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious.Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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