Molecular diagnostic controls for chlamydia and gonorrhea assays

SeraCare Life Sciences is introducing a new series of controls designed to work with highly sensitive nucleic acid assays for detection of chlamydia and gonorrhea.

ACCURUN 341 Nucleic Acid Positive controls for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) are designed to monitor and validate molecular diagnostic test performance. The controls are prepared with elementary bodies derived from cultured Chlamydia trachomatis and cultured colony-forming units of Neisseria gonorrhoeae. This whole organism design closely simulates an actual patient sample, challenging every stage of the assay from sample extraction through amplification and detection.

Through collaboration with instrument and reagent manufacturers, SeraCare optimized the controls specifically for current assay platforms. These high quality standards challenge all test kit reagents, analysers and test procedures, setting these controls apart.

Medical laboratory scientists simply add the ACCURUN 341 CT/NG Controls to the test run, just as they would an unknown patient sample, no need for reconstitution or dilutions that could possibly introduce contamination or variation into the assay. The controls are specially designed for use on the four most popular platforms currently on the market.

An advantage of this new control is the use of instrument specific vials, which allows controls to be placed directly in the test platform. Senior Product Manager for SeraCare Life Sciences Michelle Stafford explains: “This new design will significantly enhance chlamydia and gonorrhea testing overall. We’ve designed ACCURUN 341 CT/NG as a low level positive control that will challenge assays, detect errors, simplify test procedures and optimize instrument capacity. We believe that our impartially manufactured controls offer clinical diagnostic laboratories the means to ensure high quality,” she added. ACCURUN controls are rigorously tested and manufactured in ISO 9001 and 13485 certified facilities.

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