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.”
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