Pediatric Reference Intervals for Clinical Laboratory - Challenges and Opportunities - Abstract
In hematopathology and biochemistry laboratories, reference intervals are usually provided along with numeric test results, to assist clinicians to interpret patient’s test results. To establish reference intervals, the recruitment of at least 120 healthy reference individuals per partition group is usually required, in order to achieve an acceptable statistical confidence. This poses particular challenges for pediatric population as the establishment of reference intervals should take into account age, gender, and ethnic origin, the variables affecting reference intervals in children. As a
result, initiatives with multi-center involvement are currently in progress in the United States, Canada, and European countries. In such studies, both pre-analytical factors and analytical processes should be clearly defined and closely monitor to assure valid test results and reliable reference intervals are produced. Further validation is required for the transference of a published reference interval to assure its validity to be used by a different laboratory.