ABSTRACT
Biomarker research is a dynamic interdisciplinary field driven by novel technologies and by advances in basic biological science and comparative medicine. In the context of laboratory animal clinical chemistry, biomarkers usually represent endpoints measured in serum, plasma, urine, and other body fluids. Advances in assay and technology miniaturization and in sample collection have broadened the range of biomarker alternatives for laboratory animal species in which body fluids may be limited in volume or accessibility. An optimal biomarker assay must meet the resource capabilities of a given laboratory: the assay, reagents, instrumentation, and labor requirements should be affordable. After a biomarker assay has been optimized analytically, it must be "qualified" for the purposes intended. In contrast to validation which is the evaluation of assay technical performance, assay qualification is "the evidentiary process linking a biomarker with the intended biological processes or clinical endpoint".
