Ensuring Harmonized And Comparable Laboratory Measurements To Improve Public Health Programs

摘要

Measurements of exposure biomarkers are important for the assessment of health risks, the development of clinical and public health decision points, and for monitoring exposures over time. The non-comparability of biomarker measurements performed in different studies and at different times prevents the effective assessment, implementation and monitoring of public health activities. Procedures to determine, improve and track the analytical accuracy and variability of biomarker measurements are successfully used for certain clinical biomarkers. The same procedures and approaches can be applied to exposure biomarkers. Harmonization programs which create measurement results that are linked to one accuracy basis and thus are comparable across methods, locations and over time were successfully implemented for clinical analytes such as cholesterol, vitamin D and testosterone. These programs focus on the measurement accuracy and do not require laboratories to use the same analytical method. This is accomplished by providing specimens with reference values to routine laboratories. These specimens are used for assessment of accuracy and for identifying potential sources that cause inaccurate and unreliable results. For clinical analytes, these programs identified method calibration and specificity as two major sources of inaccuracy and between-laboratory variability. By continuously providing specimens with reference values and evaluating analytical performance of routine methods using consistent protocols and criteria, harmonized and comparable laboratory measurements are achieved.