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LGC SeraCare SARS-CoV-2 Molecular Controls Kit now CE-Marked

publication date: Aug 7, 2020
 | 
author/source: LGC Standards

lgc-seracare-sarscov2-molecular-controls-kit-now


LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2 Reference Material Kit v2 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 Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2 Molecular Controls Kit meets extensive design control requirements.

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 controls that challenge the entire PCR test procedure, making them the preferred alternative to infectious materials. The AccuPlex SARS-CoV-2 Molecular Controls Kit is designed to measure day-to-day assay performance and contains positive materials directed against the published CDC and WHO consensus sequences and the S gene, and negative materials targeting the human RNase P gene.

Michael Sweatt, Executive Vice President, LGC SeraCare, stated, “Achieving this regulatory milestone for this SARS-CoV-2 control kit provides added value to our customers, especially throughout the European Union where this registration is sometimes required. We are committed to continuing to support the worldwide diagnostic community with dependable quality controls for infectious diseases, including COVID-19.”

To learn more about the AccuPlex SARS-CoV-2 Molecular Controls Kit as well as the complete line of SARS-CoV-2 Molecular & Serology Quality Solutions, please visit the LGC SeraCare website.

 

Learn more about AccuPlex™

 

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.

 

About LGC

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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