Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection.

Abstract Objectives The standard RT-PCR assay for COVID-19 is laborious and time-consuming, limiting the availability of testing. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the performance of the PanbioTM COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) for SARS-CoV-2 in nasopharyngeal swab specimens. Methods This prospective multicenter study was carried out in ten Spanish university hospitals including individuals with clinical symptoms or epidemiological criteria for COVID-19. Only individuals with ≤ 7 days from the onset of symptoms or from exposure to a confirmed case of COVID-19 were included. Two nasopharyngeal samples were taken to perform the PanbioRT, as a point-of-care test, and a diagnostic RT-PCR test. Results Among the 958 patients studied, 325 (90.5%) had true-positives results. The overall sensitivity and specificity for the PanbioRT were 90.5% (CI 95%: 87.5-93.6) and 98.8% (CI 95%: 98-99.7), respectively. Sensitivity in participants who had a CT Conclusions The PanbioRT provides good clinical performance, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. The results must be interpreted based on the local epidemiological context.