LGC is pleased to announce that the ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD).
With this change in regulatory status, the new product name is ACCURUN Anti-SARS-CoV-2 Controls Kit. Bearing the CE mark and IVD symbol signifies that the ACCURUN Anti-SARS-CoV-2 Controls Kit meets extensive design control requirements.
ACCURUN controls are specifically formulated to exhibit low-positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries. The ACCURUN Anti-SARS-CoV-2 Controls Kit is offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Both products are designed to measure day-to-day assay performance and contain positive materials for antibodies against the SARS-CoV-2 virus as well as complementary negative materials.
Michael Sweatt, Executive Vice President, Clinical Diagnostics, LGC, stated, “We remain steadfast in our mission to supply the diagnostic community with dependable infectious disease quality solutions, ensuring clinical laboratories have the tools necessary to be able to report accurate and reliable patient results – during the COVID-19 pandemic and beyond.”
To learn more about the ACCURUN Anti-SARS-CoV-2 Controls Kits as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the SeraCare website.