LGC SeraCare Anti-SARS-CoV-2 Controls Kit now CE Marked
MILFORD, Massachusetts, Dec 8, 2020 – LGC SeraCare 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, LGC Clinical Diagnostics, 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 LGC SeraCare website.
Notes for editors
About LGC Clinical Diagnostics
LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.
Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.
Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.
LGC is a global leader in the life science tools sector, providing mission critical components to customers across clinical diagnostics, pharmaceutical, research & government, food and other applied markets.
LGC provides a comprehensive range of specialty genomic analysis tools, measurement tools and supply chain assurance solutions, underpinned by leading analytical and measurement science capabilities. It holds a number of international roles, including the UK Government Chemist programme and serving as the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement.
LGC’s scientific tools and solutions form an essential part of its customers’ quality assurance procedures and enable organisations to develop and commercialise new scientific products and advance research. Its 3,500 employees include internationally-recognised scientists who are experts in their field. Headquartered in London, LGC 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.
LGC was founded in 1842. It has been privately-owned since 1996 and has diversified through internal investment and acquisitions to be an international leader in its chosen markets. LGC is now owned by funds affiliated to Cinven, Astorg and ADIA.
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