Investigation of validation for biology reference interval of clinical biochemical testing / 中华检验医学杂志

ABSTRACT

Objective To validate the biology reference interval of the Dartial biochemistry test items and provide accurate diagnosis basis for the clinic.Methods According to NCCLS C28-A2 recommendation method,two biochemistry analyzers'performance was validated.20 healthy persons for the asexual biological difference project and female group as well as male group (each group consist of 20 persons)for the sex biology difference project were recruited according to the laboratory SOP.If the validation had doubt,other two groups were need.The sera from these individuals were examined by the full-automatic ADVIA 1650 biochemistry analysis system.Results Two full-automatic ADVIA 1650 biochemistry analyzes conformed to the requirements.In 16 test items participating in this investigation.the analysis showed more than 5%results fell outside the biology reference interval for GGT and HDL-C,whereas 95% results fell in the biology reference interval for TP.All other results fell in the biology reference interval.Conclusions This validation indicats that except GGT and HDL-C,the biology reference intervals which are currently being used are suitable for our laboratory.This verification is persuasive and calpable of finding the deviation of biology reference interval.Setting up verification system warrants further generalization.