摘要
目的对江苏省苯丙氨酸室内质量控制(质控)数据进行实验室间比对与分析。方法比对分析2015年度(2015年3月至2016年2月)使用相同质控品的14家江苏省新生儿疾病筛查分中心实验室检测血苯丙氨酸(Phe)的室内质控数据,计算各实验室和全省的苯丙氨酸均值(x珋)、标准差(s)、标准差指数(SDI)、变异系数(CV)、变异系数指数(CVI)、总误差(TE)、允许总误差(TEa)、临界系统误差(△SEc)等指标并做出评价。结果累计测定Phe低值质控11 477个,全省SDI、CVI、CV、TE、△SEc的合格率分别为100%、57.14%、42.86%、78.57%、14.29%;测定Phe高值质控11 502个,全省SDI、CVI、CV、TE、△SEc的合格率分别为100%、35.71%、92.86%、100%、21.43%。结论大部分实验室的质控比对结果均满足质量规范要求,但CV和CVI的统计结果表明部分实验室苯丙氨酸不精密度较大。
Objective To analyze and discuss the methodology and evaluation criteria of data comparison for internal quality control in laboratories of neonatal disease screening. Methods The internal quality control data of phenylalanine（ Phe） in blood were compared and analyzed among 14 neonatal screening sub-central laboratories in Jiangsu province where the same quality control materials were used. The items,including average Phe level（ x珋）,standard deviation（ SD）,standard deviation index（ SDI）,coefficient of variation（ CV）,coefficient of variation index（ CVI）,total error（ TE）,allowed total error（ TEa）,critical system error（ △SEc）,in the laboratories of Jiangsu province were calculated and evaluated. Results A total of 11 477 low-value quality controls were measured,and the qualification percentages of SDI,CVI,CV,TE,△SEc in Jiangsu province were 100%,57. 14%,42. 86%,78. 57%,14. 29%respectively. A total of 11 502 high-value quality controls were measured,and the qualification percentages of SDI,CVI,CV,TE,△SEc in Jiangsu province were 100%,35. 71%,92. 86%,100%,21. 43% respectively. Conclusion The quality control results in most of the laboratories of Jiangsu province met with the requirements of quality controls. The overall mean bias was small,but the statistical results of CV and CVI showed greater imprecision in some laboratories.
出处
《临床检验杂志》
CAS
CSCD
2016年第6期470-473,共4页
Chinese Journal of Clinical Laboratory Science
基金
江苏省卫生厅医学科研项目(H201343)
南京市医学科技发展重点项目(ZKX14041)
关键词
室内质量控制
室间质量评价
准确度
精密度
internal quality control
external quality assessment
accuracy
precision
