FDA has issued an emergency use authorization (EUA) for the xMap SARS-CoV-2 Multi-Antigen IgG Assay from Luminex, Austin, Texas. 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 3 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% in human serum and greater than 99% in human plasma, with sensitivity greater than 96% for both human serum and plasma (less than 14 days post-symptom onset) in clinical studies. The assay uses the advanced multiplexing capabilities of xMap instrumentation to reduce the risk of false positives and false negatives, giving laboratories increased confidence in the reliability of their test results. “More than 17,000 xMap systems have been sold to laboratories around the world, and this FDA authorization creates important new opportunities for these labs to rapidly expand their covid-19 testing capabilities with a highly accurate serology-based assay,” says Nachum “Homi” Shamir, president and CEO of Luminex. “In close collaboration with our extensive network of partners and customers, Luminex continues to be on the frontlines in the mission-critical effort to address the current pandemic with state-of-the-art testing and innovative technologies such as xMap.” For more information, visit Luminex.