FDA grants emergency use authorisation for xMAP SARS-CoV-2 Multi-Antigen IgG Assay in Coronavirus.- Luminex Corp

Luminex Corporation announced that the FDA has issued an Emergency Use Authorization (EUA) for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay. Clinical laboratories can now use this serology assay to identify the presence of antibodies in people who have been infected with the virus that causes COVID-19. The test can be run on any of Luminex’s xMAP-based high-throughput, gold-standard multiplex platforms, providing a more comprehensive and reliable assessment of immune response compared to conventional serology testing methods.

Designed to simultaneously detect antibodies against three antigens, the xMAP SARS-CoV-2 Multi-Antigen IgG Assay delivers high-quality results for up to 96 patient samples in under three hours. The assay detects antibodies of the immunoglobulin class G (IgG), which are an important component of an adaptive immune response and typically reflect sustained immunity to a given pathogen. The xMAP SARS-CoV-2 Multi-Antigen IgG Assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for both human serum and plasma (>14 days post-symptom onset) in clinical studies.