Abstract:

Objective To investigate the lower and upper limit difference of pediatric reference intervals of 13 routine chemistry items. Methods The questionnaires on reference intervals of 13 routine chemistry items were distributed to 359 clinical laboratories participating the external quality assessment（EQA） program of the National Center for Clinical Laboratories. The participating clinical laboratories reported reference intervals,methods,instruments and reagents used in prescribed form. Results The number of clinical laboratories participating in routine chemistry reference intervals was 122（30.9%）. The primary source of reference intervals were from National Guide on Clinical Laboratory Procedures and instructions of instrument and reagent manufactures（63.0%-69.3%）. Totally,44.5%-50.0% of participants had the verified reference intervals. Only a few clinical laboratories had considered different ages and sex when establishing reference intervals. There was statistical significance for lower and upper limits of urea（Urea）,creatinine（Cr）,aspartate aminotransferase（AST）,gamma-glutamyltransferase（GGT） and lower limit of alanine aminotransferase（ALT）（P<0.05）. A total of 35.0% of participants had considered different ages and sex in alkaline phosphatase（ALP）（P<0.01,P<0.05）,and there was statistical significance for its lower and upper limits for <1-year-old,1-12-year-old,13-15-year-old and >15-year-old children（P<0.05）,and there was no statistical significance in the age intra-group（P>0.05）. Conclusions The status of pediatric reference intervals of routine chemistry among clinical laboratories in China is not good. It is required to establish the pediatric reference intervals in China according to different ages and sex.

Key words: Reference interval, Routine chemistry, Children