SeraCare Introduces New STD QC
9 Nov 2011SeraCare Life Sciences has introduced a new series of controls designed for use with highly sensitive nucleic acid assays, for the detection of Chlamydia and Gonorrhea. The 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 using elementary bodies from cultures of Chlamydia and Gonorrhea bacterium so that the organism design closely mimics an actual patient sample. This challenges every assay stage from sample extraction through to amplification and detection.
SeraCare has worked closely with instrument and reagent manufacturers to optimize the controls specifically for current assay platforms. These high quality standards challenge all test kit reagents, analyzers 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. There is 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.
A significant 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.