Luminex Corporation has announced that the Food and Drug Administration (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. 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,” said 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.”
The new multi-antigen IgG assay can be run on all xMAP platforms, including MAGPIX®, the Luminex® 200, and FLEXMAP 3D®. The assay reduces time to results, minimizes the volume of sample needed, and accelerates the testing process without the need for excess labor, representing advancements over commonly used ELISA-based antibody assays.
The xMAP-based serology test is the third COVID-19 Luminex test to receive an EUA, joining the NxTAG® CoV Extended Panel and the ARIES® SARS-CoV-2 Assay, which are rapid, RNA-based SARS-CoV-2 diagnostic tests that received EUAs in March and April of this year, respectively.
The SARS-CoV-2 Multi-Antigen IgG Assay is the first of several serology tests that Luminex is developing and plans to take to market through an EUA to help during the COVID-19 crisis. Additionally, the company continues to support numerous customers and partners developing innovative xMAP-based serology assays to facilitate vaccine and therapeutic development, perform epidemiologic studies, and better understand the extent and duration of protective immunity.
The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.