The use of biomarkers has been, and will continue to be, an integral part of epidemiological research, making substantial contributions to our understanding of disease pathways and processes. New and emerging biomarkers are integral to this continued understanding. The laboratory and measurement processes behind these biomarkers often provide researchers with a less than true measurement of the intended biomarker. Reasons for this ME include intra-individual variability and instrument sensitivity among others. Acknowledging, evaluating, and adjusting for these errors is crucial for the correct assessment of individual, as well as population risk, as ME affects almost all biomarker measurement.
Researchers here have diligently investigated the sources of laboratory MEs by gaining a laboratory perspective on the measurement process ranging from sample storage and preparation to the calibrations and measurement processes of assay equipment. This understanding has provided insight to data issues commonly present yet ignored in epidemiological research. These issues have been the motivation for numerous papers as well as a collaborative effort funded by the American Chemistry Council with the goal of providing the methodological tools necessary to assess and address the issues of LOD and ME when using biomarkers.
Enrique F. Schisterman, Ph.D. & Neil Perkins, Ph.D.
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