Molecular Diagnostic Controls Optimized for Commercial Nucleic Acid Testing Platforms

SeraCare Life Sciences, Inc. have developed a new series of controls in its ACCURUN portfolio to monitor and validate molecular diagnostic test performance for detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG).

Through collaboration with instrument and reagent manufacturers, SeraCare has optimized the ACCURUN 341 Nucleic Acid Positive controls specifically for use with the three most popular assays currently on the market; the Gen-Probe APTIMA Combo 2® Assay, the Roche COBAS® AMPLICOR CT/NG Test, and the Becton, Dickinson BD ProbeTec™ ET System.

'SeraCare has again set itself apart from other controls suppliers by offering whole cell, independent controls that challenge test kit reagents, analyzers and test procedures to achieve high quality standards,' said Susan Vogt, President and CEO of SeraCare. 'The use of assay specific controls ensures optimal diagnostic performance. In addition, the controls for the Gen-Probe and BD assays are packaged in platform-compatible vials which can be placed directly on the manufacturers' automated test platforms, minimizing processing time and the risk of adventitious contamination. We believe this suite of controls offers clinical diagnostic laboratories the means to ensure high quality and achieve new standards in testing for sexually transmitted infections.'

The ACCURUN 341 Nucleic Acid Positive controls for CT/NG are derived from cultured Chlamydia trachomatis and Neisseria gonorrhoeae and closely simulate an actual patient sample, challenging every stage of the assay from sample extraction through amplification and detection. ACCURUN controls are rigorously tested and manufactured in ISO 9001 and 13485 certified facilities.