MILFORD, Massachusetts, May 28, 2020 -- LGC 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.”
To learn more about ACCURUN Anti-SARS-CoV-2 Reference Materials and the complete line of SARS-CoV-2 Quality Solutions, please visit the LGC SeraCare website.
Notes for editors
About LGC Clinical Diagnostics
LGC’s Clinical Diagnostic Business Unit exists within the LGC’s Standards Division and is comprised of two operating entities - SeraCare Life Sciences and Maine Standards Company. We are in vitro diagnostic (IVD) manufacturers of clinical diagnostic quality solutions to the extended life science industry.
Our 225+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland and support diagnostic professionals in laboratories across the globe. We partner with IVD developers, pharmaceutical, CRO and academic institutions to share our expertise and resources in clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics.
We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results.
LGC is an international leader in the extended life sciences sector, including human healthcare, agri-food & the environment. LGC provides a comprehensive range of reference materials, proficiency testing schemes, and genomics reagents, as well as research and measurement services. Its scientific tools and solutions enable organizations to advance research, develop new products and form an essential part of their quality and compliance procedures.
LGC’s 3,150 employees include internationally recognized scientists who are experts in their field. Headquartered in London, it operates out of 19 countries worldwide and is extensively accredited to quality standards such as GMP, GLP, ISO 13485, ISO 17034, ISO 17043, ISO/IEC 17025 and ISO 9001.