E. Albert, I. Torres, F. Bueno, D. Huntley, Estefanía Molla, Miguel Ángel Fernández-Fuentes, Mireia Martínez, S. Poujois, L. Forqué, A. Valdivia, C. Solano de la Asunción, J. Ferrer, J. Colomina, D. Navarro
Clinical Microbiology and Infection, 2020
Objectives To 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 COVID-19 diagnosis in symptomatic patients (n=412) attended in primary healthcare centers. Methods RAD 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 SARS-CoV-2 in cell cultures was confirmed by RT-PCR. Results Out of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD and 358 (86.9%) negative by both methods, showing discordant results (RT-PCR+/RAD-) 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.-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). Conclusion The Panbio™ COVID-19 Ag Rapid Test Device performed well as a POCT for early diagnosis of COVID-19 in primary healthcare centers. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious.
Cited by 101 publications.
Field of study: Medicine