吡喃糖氧化酶法检测1,5-脱水葡萄糖醇的空白限、检出限和功能灵敏度的建立及评价

Establishment and evaluation of blank limit,detection limit and function sensitivity of pyranose oxidase method for detecting 1,5-anhydroglucitol

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.