摘要
目的建立吡喃糖氧化酶法检测1,5-脱水葡萄糖醇(1,5-AG)的空白限(LoB)、检出限(LoD)和功能灵敏度(FS)并进行评价。方法参考美国临床和实验室标准化委员会(NCCLS)发布的EP17-A文件,将1,5-AG空白标本和系列低水平标本在ADVIA2400生化分析仪上测定1,5-AG,确定该方法的LoB、LoD和FS。结果依据NCCLSEP17-A方案建立吡喃糖氧化酶法检测1,5-AG的LoB为0.35μg/mL,LoD为0.64μg/mL,FS为0.960μg/mL。结论该研究建立了适合实验室ADVIA2400生化分析仪吡喃糖氧化酶法检测1,5-AG的LoB、LoD和FS,其分析性能指标基本满足实验室的要求,可为临床提供准确、可靠的检验结果。
Objective To establish the limit of blank (LoB),limit of detection (LoD) and the functional sensitivity (FS) of the pyranose oxidase method for detecting 1,5-anhydroglucitol (1,5-AG) and to conduct the evaluation. Methods According to the document EP17-A published by NCCLS,the blank samples and serial low level samples performed the 1,5-AG detection by the ADVIA2400 biochemical analyzer and its LoB,LoD and FS were determined. Results According to the NCCLS EP17-A schemem,LoB of pyranose oxidase for detecting 1,5-AG was 0.35 μg/mL,LoD and FS were 0.64 μg/mL and 0.960 μg/mL. Conclusion LoB,LoD and FS of the pyranose oxidase method for detecting 1,5-AG suitable for laboratory ADVIA2400 biochemical analyzer are established,its analytical performance basically meets the laboratory requirements and can provide accurate and reliable detection results for clinic.
作者
陈颖
李莎
胡婷
温冬梅
CHEN Ying;LI Sha;HU Ting;WEN Dongmei(Department of Laboratory Medicine,Affiliated Zhongshan Hospital of SUN Yat-sen University,Zhongshan,Guangdong 528403,China)
出处
《检验医学与临床》
CAS
2019年第15期2131-2133,共3页
Laboratory Medicine and Clinic
基金
广东省中山市科技计划项目(2017B1034)
广东省中山市医学科研基金项目(2016A020108)