MILFORD, Massachusetts, September 23, 2021 – LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2, Flu A/B and RSV 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 AccuPlex SARS-CoV-2, Flu A/B and RSV Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2, Flu A/B and RSV Molecular Controls Kit meets extensive design control requirements. The CE-IVD version of the product also includes expanded RSV target regions offering increased compatibility with commercially available assays.
LGC SeraCare’s proprietary AccuPlex technology mimics wild-type pathogenic viruses, but is safe, non-infectious, and replication deficient. These materials serve as true, full-process, quality control solutions that challenge the entire molecular test procedure, making them the preferred alternative to infectious materials.
Bharathi Anekella, Executive Vice President and General Manager, LGC Clinical Diagnostics, stated, “AccuPlex SARS-CoV-2, Flu A/B and RSV Molecular Controls Kit is LGC SeraCare’s fifth COVID-19 quality product to receive CE-IVD regulatory status. We want our customers to have the highest level of confidence possible in their assay results and achieving this regulatory milestone demonstrates our commitment to supplying dependable quality controls for infectious disease testing.”
To learn more about AccuPlex SARS-CoV-2, Flu A/B and RSV Molecular Controls Kit, as well as the complete line of SARS-CoV-2 Quality Solutions, please visit the LGC SeraCare website.
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About LGC Clinical Diagnostics
LGC Clinical Diagnostics 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.
For more information, please visit www.lgcgroup.com
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