Immunoassays
News on immunoassay systems and applications.
FDA Warns Against Use of Innova Medical Group SARS-CoV-2 Antigen Test
Innova had been selling the test in the US despite never having received marketing approval, clearance, or authorization, according to the FDA.
Promega Receives CE Mark for SARS-CoV-2 Antibody Test
The bioluminescent SARS-CoV-2 immunoassay enables scalable detection of antibodies against the receptor-binding domain antigen of the SARS-CoV-2 spike protein.
LivFul, Global Access Diagnostics Partner to Offer SARS-CoV-2 Antigen Testing
The partners will offer a rapid SARS-CoV-2 antigen test developed by Mologic at an affordable price in low- and middle-income nations.
Amazon, Diabetomics Get FDA Emergency Use Authorizations for Coronavirus Tests
The FDA granted EUA to Amazon subsidiary STS Lab Holdco for the Amazon Real-Time RT-PCR DTC Test and the Diabetomics CovAb SARS-CoV-2 Ab Test.
Roche Gets CE Mark for SARS-CoV-2 Antigen Self Test
An earlier version of the test has been available in some European markets under local special approval pathways since February.