孕前优生实验室临床化学检测项目分析性能评估  

Evaluation of analytical performance of clinical chemical items of pre-pregnancy laboratory tests

作　　者：张瑞金 吴玉璘 周青 刘帅妹 李孟兰 封婕 黄丽丽 林宁 ZHANG Ruijin;WU Yulin;ZHOU Qing;LIU Shuaimei;LI Menglan;FENG Jie;HUANG Lili;LIN Ning(Jiangsu Health Development Research Center,Nanjing 210036,China)

机构地区：[1]江苏省卫生健康发展研究中心中心实验室,南京210036

出　　处：《中国生育健康杂志》2023年第2期131-137,共7页Chinese Journal of Reproductive Health

基　　金：江苏省卫生健康委妇幼健康项目(F202126)。

摘　　要：目的使用六西格玛(6σ)方法评价江苏省部分孕前优生实验室临床化学检测项目的分析性能。方法收集江苏省38个孕前优生实验室2021年7~10月丙氨酸氨基转移酶(Alt)、肌酐(Cr)和葡萄糖(Glu)室内质控数据计算累计变异系数(CV,%),根据江苏省2021年第二次国家免费孕前优生健康检查项目室间质量评价结果计算偏倚(Bias,%),采用卫生行业标准(WS/T403-2012)规定的允许总误差(TEa,%),计算每个项目的σ质量水平,并对分析性能进行评估。对σ在6.0以下的项目计算质量目标指数(QGI),确定优先改进方向。结果Alt、Cr和Glu分别有68.5%、63.1%和34.2%的实验室σ水平在4.0及以上,有31.6%、36.8%和10.5%的实验室σ水平在6.0及以上;σ水平在3.0以下的实验室占比分别为15.8%、15.8%和47.4%;σ在6.0以下的项目中,QGI<0.8的实验室占比分别为57.7%、62.5%和61.8%;QGI>1.2的实验室占比分别为15.4%、12.5%和29.4%。结论Alt和Cr分析性能较好,Glu分析性能普遍不佳;半数以上实验室显示需要优先改进检测精密度。Objective To evaluate the analytical performance of clinical chemical items of pre-pregnancy laboratories tests of Jiangsu Province using six sigma(6σ)theory.Methods The coefficient of variation(CV,%)of Alt,Cr and Glu were cumulated using the internal quality control data from 38 laboratories in Jiangsu from July 1 to October 31,2021.The Bias(%)was calculated according to the results of the second external quality assessment of National Free Pre-pregnancy health examination of Jiangsu province in 2021.The allowed total error(TEa,%)stipulated in the health industry standard(WS/T403-2012)was adopted.σwas calculated for each item and the quality goal index(QGI)was calculated for items withσbelow 6.0.Results For Alt,Cr and Glu items,there are 68.5%,63.1%and 34.2%of laboratories had aσlevel of 4.0 or above,31.6%,and 36.8%and 10.5%of laboratories had aσlevel of 6.0 or above,and 15.8%,15.8%and 47.4%of laboratories had aσlevel below 3.0,respectively.Among the items withσbelow 6.0,the laboratories with QGI<0.8 accounts for 57.7%,62.5%and 61.8%,respectively,and 15.4%,12.5%and 29.4%for QGI>1.2,respectively.Conclusion Alt and Cr have good analytical performance,but Glu is still far from satisfactory.More than half of the laboratories need improving test precision as a priority.

关 键 词：六西格玛(6σ) 分析性能 质量目标指数 允许总误差 

分 类 号：R17[医药卫生—妇幼卫生保健]