Cellex is a biotechnology company that develops technologies, instruments and diagnostic assays for human diseases and conditions with emphasis on point-of-care settings. Cellex’s main R&D staff are located at Research Triangle Park (RTP), North Carolina. The company’s manufacturing facilities are located at RTP an in Suzhou China.
Cellex were the first to have a serological test to detect antibodies to the COVID-19 coronavirus SARS-CoV-2 approved in the US by the FDA under emergency use authorization (EUA) on April 1, 2020. The test analyzes blood samples in authorized labs with a 15-20 minute test that detects two types of antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG). IgM is the first antibody the body makes to a foreign substance, appearing a few days after infection. The body later produces large quantities of IgG. A positive result can mean a person is currently or was recently infected with SARS-CoV-2.
FDA authorizes Cellex coronavirus antibodies test
April 3, 2020
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- Cluster: COVID-19A cluster of topics related to COVID-19. COVID-19 is the abbreviated name for coronavirus disease 2019, a respiratory disease caused by a novel coronavirus strain called SARS-CoV-2. COVID-19 was first detected in Wuhan City, China and the outbreak was declared a pandemic on March 11, 2020 by the WHO.