The clinical laboratories can use the new serology assay to detect the presence of antibodies in people who have been infected with the virus that results in Covid-19
Luminex has secured FDA EUA status for Covid-19 antibody test. (Credit: fernando zhiminaicela from Pixabay)
Luminex has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its xMAP SARS-CoV-2 multi-antigen IgG assay.
The EUA status enables clinical laboratories to use the serology assay to detect the presence of antibodies in people who have been infected with the virus that results in Covid-19.
Luminex’s xMAP SARS-CoV-2 multi-antigen IgG assay has the capacity to simultaneously identify antibodies against three antigens and deliver results for up to 96 patient samples within three hours.
The assay identifies antibodies of the immunoglobulin class G (IgG), which are a crucial component of an adaptive immune response.
All xMAP platforms are suitable to run the new multi-antigen IgG assay
The new multi-antigen IgG assay has the capacity to run on all xMAP platforms, including MAGPIX, Luminex 200, and FLEXMAP 3D.
The xMAP-based serology test is said to be the third Covid-19 Luminex test to secure FDA EUA status. Other tests include the NxTAG CoV extended panel and the ARIES SARS-CoV-2 assay, which are rapid and RNA-based SARS-CoV-2 diagnostic tests that secure EUAs in March and April of this year.
Luminex’s ARIES system is an FDA-cleared, sample-to-answer, automated and on-demand molecular diagnostic platform.
The ARIES system holds the capacity to run up to 144 tests per day, as well as needs no specialty training and minimal human interaction.
Luminex president and CEO Nachum Homi Shamir said: “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.
“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.”