Principal Scientist IQVIA Laboratories Indianapolis, Indiana
Description: This presentation is a background and case study of the nitrate anion assay – an unconventional assay for an unconventional biomarker. We address why LCMS was chosen over marketed kit analysis of nitrate in human plasma, why nitrate would be used in a pharmacological setting as a biomarker, and how the assay was developed and validated. In the second half, we talk about how to approach troubleshooting an assay where contamination originates from the air itself.
Learning Objectives:
Why would a biomarker like the nitrate anion be useful in a pharmacological setting when nitrate is non-specific to the human body? Why LCMS and not an off-the-shelf kit?
Understanding the complex nature of biomarker assay development and use when the biomarker is ultra small and environmentally ubiquitous
How to approach troubleshooting when a challenging assay fails to perform in production after a period of dormancy
