www.fdanews.com/articles/198141-luminex-earns-fdas-emergency-use-authorization-for-covid-19-antibody-test
Luminex Earns FDA’s Emergency Use Authorization for COVID-19 Antibody Test
July 21, 2020
The FDA has granted Emergency Use Authorization (EUA) for Luminex’s xMAP SARS-CoV-2 multi-antigen IgG assay.
The serology assay, Luminex’s third COVID-19 test to receive an EUA since March, is used to identify the presence of antibodies in patients infected by the coronavirus.
The test simultaneously detects antibodies against three antigens and can handle up to 96 patient samples in under three hours. It is run on Luminex’s xMAP-based multiplex platforms.