NEW YORK – LGC SeraCare announced Tuesday its Anti-SARS-CoV-2 controls kit received CE-IVD marking.
The Accurun Anti-SARS-CoV-2 Controls Kit is designed to exhibit low-positive reactivity so it can test assay performance near signal cutoff boundaries, the firm said in a statement. It comes in two configurations, one for IgG-specific tests and one for total antibody tests. The IgG configuration is released using the Abbott Architect SARS-CoV-2 IgG test and the total antibody version is released using the Roche Cobas Elecsys Anti-SARS-CoV-2 test, according to the company's website.
Both configurations are designed to measure day-to-day test performance and have positive materials for SARS-CoV-2 antibodies and complementary negative materials, the UK-based firm added.
The controls kit was formerly called the Accurun Anti-SARS-CoV-2 Reference Material Kit.
The presence of IgG or IgM antibodies can help determine someone's immune status to a recent or past SARS-CoV-2 infection, with IgM antibodies being detected earlier in infections and dissipating and IgG antibodies linked to longer-term immune response.