Healthcare analytics and diagnostics company Genalyte has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its rapid Covid-19 antibody test.
The EUA status has been provided for Genalyte’s SARS-CoV-2 multi-antigen serology panel to facilitate the identification of IgG and IgM antibodies produced by the body in response to the novel coronavirus (SARS-CoV-2).
Genalyte founder and chief technology officer Cary Gunn said: “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.”
Genalyte’s test provides lab-quality results in 20 minutes
With the company’s FDA-cleared Maverick diagnostic system, the multi-antigen serology panel is designed to deliver central and lab-quality results in 20 minutes at point-of-care locations.
The SARS-CoV-2 multi-antigen serology panel is said to test for IgM and IgG antibodies against 13 unique viral antigens.
By using a machine learning approach, the panel helps to achieve 98% specificity and 96% sensitivity. It also enables to minimise false positives.
According to the company, the SARS-CoV-2 multi-antigen serology panel is poised to become an increasingly significant tool as serology-based antibody testing expands in the fight against Covid-19.
Genalyte CEO Ashraf Hanna said: “An effective Covid-19 vaccination programme will benefit from accurate, reliable serology testing. We are pleased to receive the Emergency Use Authorisation from the FDA and look forward to being part of the solution in combating Covid-19.”
Recently, Abbott secured EUA status for its Covid-19 IgM (Immunoglobulin M) antibody blood test. The EUA status has been granted for AdviseDx SARS-CoV-2 IgM lab-based serology test for use on the Architect and Alinity platforms.
