基层临床检验实验室孕前优生健康检查生化项目测量不确定度的评价

Evaluation of measurement uncertainty in clinical chemistry assays related to pre-conception health in local setting

目的利用基层临床检验实验室的室内质量控制(IQC)和室间质量评价(EQA)的累积数据对孕前优生健康检查生化项目的测量不确定度进行评价,并探讨该方法在基层临床检验实验室的适用性。方法收集某基层临床检验实验室2014年10月1日~2015年11月30日生化项目的 IQC数据和2013~2015年江苏省孕前优生项目临床检验实验室EQA的结果。按照Nordtest准则,评估丙氨酸转氨酶(ALT)、肌酐(Cr)、葡萄糖(Glu)的合成不确定度和扩展不确定度。结果在孕前优生健康检查生化项目中,各项的扩展不确定度均大于10%(ALT:P22.24%,N 36.97%;Cr:P 10.71%,N 12.62%;Glu:P 11.22%,N 10.11%),其中,扩展不确定度最大的项目是ALT中值,最小的是GLU中值;且与偏倚相关的不确定度是合成不确定度的主要来源。结论使用IQC数据和EQA结果对孕前优生健康检查生化项目的测量不确定度进行评估,方法简单,具有一定的可行性,可在基层临床检验实验室尝试开展,有助于提升基层临床检验实验室的检测质量。

Objective To evaluate uncertainty of clinical chemical assays related to pre-conception health on the basis of the internal quality control （IQC） and external quality assessment （EQA） results in clinical laboratory, and to explore the potential application of this method. Methods The IQC data （from October 1, 2014 to November 30, 2015） and E- QA results （from 2013 to 2015） of clinical laboratory in local setting were collected. According to the Nordtest guideline, the combined uncertainty and extended uncertainty of three clinical chemistry assays （glucose （Glu）, creatinine （Cr）, alanine aminotransferase （ALT）） were evaluated. Results Of all the clinical chemistry assays related to pre-eon- ception health,all expanded uncertainties tested in this study were more than 10% （ALT：P 22.24%,N 36.97%;Cr：P 10.71%,N 12.62%;Glu：P 11.22%, N 10.11%）. The assay testing the medium level of ALT revealed the highest expanded uncertainty, and the assay measuring the medium level of Glu showed the lowest expanded uncertainty.Further, the uncertainty associated with bias was the major source of the combined uncertainty. Conclusion The assessment of measurement uncertainty in clinical chemistry assays using IQC and EQA is easy and feasible. The evaluation of measurement uncertainty is beneficial to improve the quality of detection of clinical laboratory in local setting.