Series of Controls Validate Molecular Diagnostics Performance

A control portfolio has been developed that will monitor and validate molecular diagnostic test performance for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG).

The Nucleic Acid Positive controls for CT/NG are derived from cultured C. trachomatis and N. gonorrhoeae and they closely simulate an actual patient sample, challenging every stage of the assay from sample extraction through amplification and detection.

The ACCURUN 341 Nucleic Acid Positive controls have been optimized for use with the three most popular assays currently on the market: the APTIMA Combo 2 Assay (Gen-Probe, San Diego, CA, USA); the COBAS AMPLICOR CT/NG Test (Roche, Basel, Switzerland); and the BD ProbeTec ET System (Becton, Dickinson and Company; Franklin Lakes, NJ, USA).

The Accurin 341 controls are marketed by SeraCare Life Sciences, Inc, (Milford, MA, USA). The company has collaborated with the other instrument and reagent manufacturers to perfect their reagents. SeraCare is offering whole cell, independent controls that challenge test kit reagents, analyzers and test procedures to achieve high quality standards. Validation of tests for sexually transmitted diseases is an essential core component for the automated clinical laboratory.

Susan Vogt, president and CEO of SeraCare said, "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.” ACCURUN controls are rigorously tested and manufactured in ISO 9001 and 13485 certified facilities.

Related Links:
SeraCare Life Sciences
Gen-Probe
Roche
Becton, Dickinson