title: Establishing reference intervals for clinical laboratory test results: is there a better way?
abstract: Reference intervals are essential for clinical laboratory test interpretation and patient care. Methods for estimating them are expensive, difficult to perform, often inaccurate, and nonreproducible. A computerized indirect Hoffmann method was studied for accuracy and reproducibility. The study used data collected retrospectively for 5 analytes without exclusions and filtering from a nationwide chain of clinical reference laboratories in the United States. The accuracy was assessed by the comparability of reference intervals as calculated by the new method with published peer-reviewed studies, and reproducibility was assessed by the comparability of 2 sets of reference intervals derived from 2 different data sets. There was no statistically significant difference between the calculated and published reference intervals or between the 2 sets of intervals that were derived from different data sets. A computerized Hoffmann method for indirect estimation of reference intervals using stored test results is proved to be accurate and reproducible.
authors.affiliation: Department of Science and Technology, Laboratory Corporation of America, Burlington, NC, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: Katayev
authors.forename: Claudiu
authors.initials: C
authors.lastname: Balciza
authors.forename: David W
authors.initials: DW
authors.lastname: Seccombe
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D012016:Reference Values; D015203:Reproducibility of Results; D012984:Software