Sample-to-Results: Novel Solutions for Improved Process Control in Molecular IVD Assays

Tuesday, August 6, 7 – 8:30 a.m.
Hilton Anaheim, California A Room
Supported by Meridian Bioscience

Overview

As the IVD industry continues to evolve, new regulations frequently come into place to better control an innovative and growing industry. In particular, molecular IVDs are experiencing tighter regulations on the presence of appropriate controls with 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.

Outcomes

Attendees will learn to:

  • Understand the type of controls required for molecular diagnostic assays and how the regulations are changing globally.
  • Know the new industry solutions for IVD manufacturers for these sample processing controls.

Speaker

Florent Chang-Pi-Hin
Director of Research & Development
Meridian Bioscience
London, UK