The SARS-CoV-2 Multi-Antigen Serology Panel from Genalyte, San Diego, has received FDA emergency use authorization (EUA). The panel tests for IgG and IgM antibodies produced in response to infection with the novel coronavirus (SARS-CoV-2), and it delivers lab-quality results in 20 minutes at point-of-care.
“Our SARS-CoV-2 Multi-Antigen Serology Panel and Maverick instrument provide a much-needed, rapid testing solution that can help people understand if they have been previously infected with SARS-CoV-2,” says Cary Gunn, founder and chief technology officer at Genalyte. “It enables healthcare professionals to confidently provide accurate, serological results in clinical and public health settings—which then enables them to better estimate how many people have been infected with SARS-CoV-2, the virus that causes COVID-19, and helps guide a better understanding of the virus.”
Genalyte’s SARS-CoV-2 Multi-Antigen Serology Panel tests for IgM and IgG antibodies against 13 unique viral antigens. IgG antibodies, in particular, remain long after a person has recovered and are believed to be a marker of sustained immunity, although the duration of immunity to SARS-CoV-2 needs continued study. Utilizing a machine learning approach, the panel is able to virtually eliminate false positives, achieving 98% specificity and 96% sensitivity.
For more information visit Genalyte.