July 23, 2020—Luminex Corp. announced that the FDA issued an emergency use authorization for the company’s xMAP SARS-CoV-2 Multi-Antigen IgG Assay.
The assay demonstrated specificity of 100 percent in human serum and greater than 99 percent in human plasma, with sensitivity greater than 96 percent for human serum and plasma (>14 days post-symptom onset) in clinical studies.
The assay is designed to simultaneously detect antibodies against three antigens and delivers results for up to 96 patient samples in less than three hours. The test can run on any of Luminex’s xMAP-based high-throughput multiplex platforms.
The xMAP-based serology test is the third COVID-19 Luminex test to receive an EUA; the NxTAG CoV Extended Panel and the ARIES SARS-CoV-2 Assay received EUAs in March and April, respectively.