As the IVD industry continues to evolve, new regulations frequently come into place to better control an innovative and growing industry. Molecular IVDs in particular are experiencing tighter regulations regarding the presence of appropriate controls within the assay. All tests must include both positive and negative controls which are subjected to the whole testing process, including the extraction step. Novel co-extracted exogenous controls are providing cutting edge solutions for monitoring RNA or DNA analysis including the detection of potential inhibition. These controls can be used across a variety of sample types and assays, representing a significant advantage over traditional spike-in controls.
Michele Amasio, Ph.D. (Research and Development Senior Manager, Meridian Bioscience)
Steve Hawkins, PhD (Product Marketing Manager, Meridian Bioscience)