Luminex Unveils COVID-19 Antibody Test
Luminex Corporation has announced that the company has submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration (FDA) for its xMAP® SARS-CoV-2 Multi-Antigen IgG assay. The assay was developed to provide additional capacity to detect antibodies in patients who may have been exposed to or infected by SARS-CoV-2. It delivers results for up to 96 samples in under three hours and is designed to be run on all xMAP® platforms, with more than 17,000 systems sold globally, and 65+ Luminex global partners offering 1,300+ kits and custom assay solutions.
SARS-CoV-2 antibodies can be detected in both plasma and serum, usually within one to three weeks after infection. These antibodies help determine whether a person has previously been infected by SARS-CoV-2 and may have developed some level of immunity to the disease. The new serology test detects antibodies of the immunoglobulin class G (IgG), which are an important component of an adaptive immune response and typically reflect sustained immunity. The xMAP SARS-CoV-2 Multi-Antigen IgG assay uses multiplexing to simultaneously detect antibodies to three SARS-CoV-2 antigens and includes multiple internal controls to provide a more comprehensive and reliable assessment of the immune response compared to other serology assays.
"By expanding our COVID-19 testing offerings into serology testing with our first multi-antigen IgG assay, Luminex is taking another important step to support laboratories and research institutions that are working to meet the continued high demand for a range of testing solutions," said Nachum "Homi" Shamir, President and CEO of Luminex. "Serology testing is essential because it uniquely detects prior exposure to a pathogen, as well as possible immunity. Our xMAP technology is ideally suited for serology testing because of its proven ability to deliver extremely high specificity and sensitivity on a high-throughput, gold-standard multiplex platform."
The Luminex IgG serology test is the first in a series of such tests that Luminex plans to develop internally to address the breadth of testing and surveillance needs related to the COVID-19 pandemic. The company plans to launch the test for Research Use Only (RUO) later this month. Luminex previously launched two SARS-CoV-2 diagnostic tests for use by both high-complexity, high-throughput reference labs and moderate complexity, sample-to-answer testing locations, on the company's MAGPIX® System and ARIES® System, respectively.
"In addition to commercializing our own serology tests, Luminex will continue to support a number of highly reputable academic medical centers and research labs, as well as a growing number of partners, that are conducting research into innovative serological applications on the open xMAP® platform. This research is facilitating vaccine and therapy development, enhancing pandemic surveillance by quantifying exposure rates in communities, and studying the dynamics of the immune response to better understand the extent and longevity of protective immunity," said Shamir.