Harmonization of Liquid Chromatography-Tandem Mass Spectrometry Protein Assays.

Harmonization of diagnostic test results is fundamental to the effective use of laboratory testing in the diagnosis, treatment, and monitoring of disease. Formal approaches to harmonization and standardization provide a rigorous and high-quality roadmap to this end, although the formal harmonization process can be long and complex. In the meantime, more informal approaches to harmonization can provide a useful pathway to improved harmonization in the short term. Factors relevant to harmonization are discussed with particular attention to protein assays using LC-MS/MS. Published formal and informal harmonization projects are provided as examples, including lessons drawn from these projects.