Performance of Gazelle COVID-19 point-of-care test for detection of nucleocapsid antigen from SARS-CoV-2

SARS-CoV-2 antigen assays offer simplicity and rapidity in diagnosing COVID-19. We assessed the clinical performance of Gazelle COVID-19 test, a fluorescent lateral flow immunoassay with an accompanying Reader utilizing image-recognition software for detection of nucleocapsid antigen from SARS-CoV-2. We performed a prospective, operator-blinded, observational study at 2 point-of-care (POC) sites. Nasal swab specimens from symptomatic patients were tested with Gazelle COVID-19 test and real-time polymerase chain reaction (RT-P CR) assay. Overall, data from 1524 subjects was analyzed, and 133 were positive by RT-PCR. Mean (range) age of participants was 34.7 (2-94) years and 570 (37.4%) were female. The sensitivity and the specificity of the Gazelle COVID-19 test were 96.3% and 99.7%. The PPV of Gazelle COVID-19 test was 97.0%, NPV 99.6%, and accuracy 99.4%. In POC settings, Gazelle COVID-19 test had high diagnostic accuracy for detection of SARS-CoV-2 in nasal swab samples of symptomatic subjects suspected of COVID-19.