六种肝功能指标检测能力验证研究  

Proficiency testing on determination of 6 kinds of liver function indices

作　　者：苗玉发[1] 顾玥 王超[1] 张琳[1] 潘东升[1] 王雪[1] 吕建军[1] 黄芝瑛[2] 张河战[1] MIAO Yu-Fa;GU Yue;WANG Chao;ZHANG Lin;PAN Dong-Sheng;WANG Xue;LV Jian-Jun;HUANG Zhl-Ylng;ZHANG He-Zhan(National Institutes for Food and Drug Control, Beijing 100176, China;School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou 510006, China)

机构地区：[1]中国食品药品检定研究院,北京100176 [2]中山大学药学院,广州510006

出　　处：《食品安全质量检测学报》2018年第7期1599-1604,共6页Journal of Food Safety and Quality

基　　金：国家"重大新药创制"科技重大专项(2018ZX09201017-001-003)~~

摘　　要：目的评价食品药品检测机构对丙氨酸转氨酶(alanine aminotransferase,ALT)、天冬氨酸转氨酶(aspartate animotransferase,AST)、碱性磷酸酶(alkaline phosphatase,ALP)、总胆红素(total bilirubin,TBIL)、总蛋白(total protein,TP)以及白蛋白(albumin,ALB)等6种肝功指标的检测能力。方法分别采用单因素方差分析和t检验法对能力验证样品的均匀性和稳定性进行研究。对能力验证数据进行正态性检验,按照能力验证评价标准,对各实验室的结果进行评价。结果 ALT满意率为97.5%,AST满意率97.6%,ALP满意率为100%,TBIL满意率为74.2%,TP满意率为90%,ALB满意率为97.5%。结论通过此次能力验证研究,发现部分实验室的肝功能生化指标检测能力缺陷,促进了实验室的质量改进。Objective To evaluate the ability for detection 6 kinds of liver function indices by Chinese institutions of food and drug control, including alanine aminotransferase（ALT）, aspartate animotransferase（AST）, alkaline phosphatase（ALP）, total bilirubin（TBIL）, total protein（TP） and albumin（ALB）. Methods The uniformity and stability of proficiency testing samples were analyzed by one-way ANOVA and t test, respectively. Normality test was performed for data distribution, and the proficiency testing results were evaluated according to evaluation criterias. Results The satisfaction rate of ALT was 97.5%, the satisfaction rate of AST was 97.6%, the satisfaction rate of ALP was 100%, the satisfaction rate of TBIL was 74.2%, the satisfaction rate of TP was 90% and the satisfaction rate of ALB was 97.5%, respectively. Conclusion Through this study, the detection ability defects of liver function indices were discovered in several laboratories, thus it promoted the quality improvement of the laboratory.

关 键 词：肝功能指标 均匀性和稳定性 能力验证 

分 类 号：TS207.3[轻工技术与工程—食品科学]