SARS-CoV-2 Reference Materials Now Includes Serology Quality Solutions
Jun 04 2020 Read 327 Times
LGC’s SeraCare has released ACCURUN® Anti-SARS-CoV-2 Reference Materials to address the critical need for clinical laboratories to be able to report antibody testing results with confidence, in response to the ongoing COVID-19 pandemic. The ACCURUN kit is designed to support assay installation as well as to monitor day-to-day assay performance, as required by CLIA, CAP, ISO-15189 and many other regulatory or accrediting bodies, providing a complete quality solution for SARS-CoV-2 antibody testing.
To support the multiple SARS-CoV-2 serology assay formats available, the product is currently offered in two configurations, one designed for IgG-specific assays and the other for total antibody tests. Both versions include positive materials for antibodies against the SARS-CoV-2 virus as well as complementary negative materials. ACCURUN reference materials are specifically formulated to exhibit low-positive reactivity in true patient-like matrices, to test assay performance near critical signal cutoff boundaries.
Michael Sweatt, Executive Vice President, LGC SeraCare, stated: “SeraCare has provided gold standard third-party run controls and reference materials to clinical laboratories for more than 30 years. We are privileged to be able to apply our expertise and expand our premier ACCURUN line of infectious disease quality solutions to support expanded SARS-CoV-2 antibody testing during this pandemic. The ACCURUN Anti-SARS-CoV-2 Reference Material Kit is a valuable tool to accelerate development, validation, and implementation of antibody testing, necessary to ensure accurate evaluation of COVID-19 infection status to support treatment and containment efforts.”
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