Comparison and analysis of the reference intervals of 9 analytes with current industry standards in routine chemistry

Abstract

Objective To investigate the current application status of reference intervals in routine chemistry and compare with the current health industry standards. Methods By using web-based external quality assessmentsoftware system,data were collectedfrom the laboratories which attended 2012 national reference intervals investigation, including the sources of reference intervals, upper and lower limits, subgroups and grouping rules, test methods, instruments and reagents, etc. Microsoft Excel 2007 and SPSS 13.0 were used to analyze the trimmed data. Results There were 385 laboratories submitting the reference intervals they had been using. Only a few of laboratories' reference intervalsweregrouped. There are some differences in grouping rulescompared with the currentstandards. Even though some of the laboratories adopt the grouping rules as the same as the standards, there are still significantstatistical differences in reference intervals between the laboratories and the health industry standards (P<0.01). Conclusions The reference intervals of routine chemistry items suggested by the health industry standards have quite big differences from thoseused in current clinical laboratories dailywork,that might be related from the population they served and many internal influence factors. If the health industry standards are used, the evaluation and validation of reference intervals should be done first.（Chin J Lab Med,2014,37:709-711） Key words: Diagnostic tests, routine; Clinical chemistry tests; Reference values; Reference standards