Healthcare company Luminex Corporation (NASDAQ:LMNX) said on Monday that it has filed an Emergency Use Authorization request with the US Food and Drug Administration (FDA) for its xMAP SARS-CoV-2 Multi-Antigen IgG assay to detect antibodies in patients who may have been exposed to or infected by SARS-CoV-2, with a planned launch for Research Use Only (RUO) later this month.
The company added that the xMAP SARS-CoV-2 Multi-Antigen IgG assay delivers excellent results for up to 96 samples in under three hours and is designed to be run on all xMAP platforms. The assay uses multiplexing to simultaneously detect antibodies to three SARS-CoV-2 antigens and includes multiple internal controls to provide assessment of the immune response compared to other serology assays.
SARS-CoV-2 antibodies can be detected in both plasma and serum, usually within one to three weeks after infection. 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, concluded the company.
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