临床实验室干式生化检测项目测量不确定度的评估与分析

目的 根据西安市儿童医院干式生化室内质控和卫健委临检中心室间质评的累积数据,评价13项干式生化检测项目的测量不确定度。方法收集西安市儿童医院检验科2018年6～12月,13项干式生化检测项目的室内质控数据(生理水平和病理水平)和2017～2019年间干式生化室间质评的数据,依据Nordtest准则,计算与精密度和偏移相关的相对不确定度分量,评估合成相对标准不确定度和扩展相对不确定度。结果 13项干式生化检测项目的扩展相对不确定度范围为5.23%～17.41%,其中丙氨酸氨基转移酶(ALT)的生理水平扩展相对不确定度最大(17.41%),总蛋白(TP)的生理水平扩展相对不确定度最小(5.23%)。尿素(BUN)的生理水平和总胆固醇(TC)的病理水平的扩展相对不确定度不符合实验室目标不确定度,分别为10.93%和10.76%,其余项目均符合。结论 Nordtest准则适用于儿童医院临床实验室干式生化检测项目测量不确定度的评估,能更好地为临床提供结果咨询。

Evaluation and Analysis of Uncertainty in Measurementof Dry Biochemical Testing Items in Clinical Laboratories

Objective Based on the accumulated data of thedry biochemical laboratory quality control and the external quality assessment of the clinic inspection center of the Health and Health Commission of Xi'an Children's Hospital,the measurement uncertainty of 13 dry biochemical testing items was evaluated.Methods Collected the data of indoor quality control(physiological and pathological level)of 13 dry biochemical testing items from June to December 2018 in Department of Clinical Laboratory of Xi'an Children's Hospital and data of dry biochemical external quality assessmentfrom 2017 to 2019.According to Nordtest criterion,the relative uncertainty components related to precision and migration were calculated,and the combined relative standard uncertainty and extended relative uncertainty were evaluated.Results The expanded relative uncertainty of 13 dry biochemical testing items ranged from 5.23% to 17.41%.The expanded relative uncertainty of physiological level of ALT was the largest(17.41%)and that of TP was the smallest(5.23%).The expanded relative uncertainty of physiological level ofBUN and pathological level of TC did not accord with the laboratory target uncertainty,which was 10.93% and 10.76% respectively.The other items were accorded with it.Conclusion Nordtest criteria are applicableto the evaluation of uncertainty in measurement of dry biochemical testing itemsin clinical laboratories of children's hospitals,and provide better results consultation for clinical practice.