The PerkinElmer COVID-19 Antigen Test is a CE marked in vitro diagnostic device for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal or nasopharyngeal swab specimens. The lateral flow immunoassay test can be used to screen or aid in the diagnosis of COVID-19 in asymptomatic or symptomatic individuals. A positive or negative result can be obtained as early as 15 minutes to facilitate immediate isolation or treatment decisions.
The test is ideally suited for point-of-care (POC) clinical and non-clinical settings such as healthcare centers, travel hubs, businesses and educational institutions. Clinical studies in symptomatic and asymptomatic populations, including individuals with low viral load, have shown sensitivity >97% amongst all samples. Specificity of the test across 202 negative samples was 100%, which means no false positives were identified. The PerkinElmer COVID-19 Antigen Test was tested against the most-sensitive commercially available RT-PCR kit on the market (FDA Reference Panel Comparative Data. Oct. 2, 2020)+.