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LGC Receives CE Mark for AccuPlex SARS-CoV-2, Flu A/B, RSV Reference Material Kit

NEW YORK – LGC SeraCare said on Thursday that it has received CE marking for its AccuPlex SARS-CoV-2, Flu A/B, and RSV Reference Material Kit.

Concurrent with the change in regulatory status, the company changed the kit's name to AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit. The CE-IVD version of the product also includes expanded RSV target regions for increased compatibility with commercially available assays, LGC said.

The company originally launched a kit with reference material for SARS-CoV-2 in March 2020. It contained positive reference material targeting the consensus sequences published by the US Centers for Disease Control and Prevention and the World Health Organization, as well as complementary negative reference material targeting the human RNAse P gene. LGC said at the time that its kit was superior to "naked" transcribed RNA and safer than heat-treated infectious samples.

The company's AccuPlex technology mimics wild-type pathogenic viruses but is noninfectious and replication deficient. This kit is the firm's fifth COVID-19 quality control product to obtain the CE mark.