Establishing reference intervals for clinical laboratory test results: is there a better way?

Am J Clin Pathol. 2010 Feb;133(2):180-6. doi: 10.1309/AJCPN5BMTSF1CDYP.


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.

Publication types

  • Evaluation Study

MeSH terms

  • Clinical Laboratory Techniques / methods*
  • Clinical Laboratory Techniques / statistics & numerical data
  • Humans
  • Reference Values*
  • Reproducibility of Results
  • Software