临床生化检验项目生物参考区间适用性验证探讨

目的 对实验室现用生化检验部分项目的生物参考区间进行验证,确保其适用于本实验室,为临床提供准确的诊断依据.方法 参照NCCLS C28-A2推荐方法,先对实验室2台生化分析系统性能进行验证;无性别生物差异项目验证选择一组(20名)健康参考个体,有性别生物差异项目选取男、女两组(各20名),验证存在疑问项目,另外选取男、女两组健康参考个体.采集符合要求健康参考个体标本,按实验室标准化操作程序(SOP)文件要求进行规范检测,拜耳ADVIA 1650生化分析系统检测标本,分析实验结果情况.结果 经验证2台生化分析系统性能符合要求;参与验证的16个项目中,健康参考个体组检测结果:γ谷氨酰转移酶(GGT)、高密度脂蛋白胆固醇(HDL.C)5%以上在现用的生物参考区间以外;总蛋白95%结果在现用的生物区间内;其余项目100%在现用的生物区间内.结论 本次验证的项目除GGT、HDL-C外,现用的生物参考区间适用于本实验室,可以继续使用;实验的验证具有科学的说服力,容易发现生物参考区间的偏离,建立完善的验证制度、程序,值得推广应用.

Investigation of validation for biology reference interval of clinical biochemical testing

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.