标题：吡喃糖氧化酶法检测血清1,5-脱水葡萄糖醇的方法学性能评价

      作者：陈颖，李莎，索明环，王伟佳    中山大学附属中山医院检验医学中心，广东 中山 528403

      卷次： 2020年31卷3期

      【摘要】 目的 评价吡喃糖氧化酶法检测血清1,5-脱水葡萄糖醇(1,5-AG)的方法学性能。方法 参考美国临床和实验室标准化协会(CLSI)发布的方法学评价文件，对吡喃糖氧化酶法检测血清1,5-AG的精密度、正确度、抗干扰性、分析测量范围(AMR)、临床可报告范围(CRR)、生物参考区间进行评价和验证，并与厂家声明的性能和有关的质量标准进行比较。结果 吡喃糖氧化酶法检测血清低高水平1,5-AG的批内精密度为1.58%和0.76%，批间精密度为 3.37%和 1.22%，小于厂家声明的标准；正确度验证显示与配套校准品标示值的偏倚为 1.42%和 1.27%，小于10%的质量目标；抗干扰评估显示，当TG≤500 mg/dL、Bil≤50 mg/dL、Hb≤20 mg/dL和VitC≤50 mg/dL时无显著干扰；AMR验证判断最佳拟合方程为二次多项式，血清 1,5-AG浓度在 0.16~49.82 μg/mL范围内存在线性关系；CRR最大稀释倍数是 32倍，范围为 0.35~1 594.24 μg/mL。生物参考区间验证显示本研究选择的参考个体血清 1,5-AG水平符合厂家试剂说明书给定的参考区间。结论 吡喃糖氧化酶法检测血清1,5-AG的各项性能指标均符合检测的要求，其可为实验室和临床提供可靠的1,5-AG结果；厂家声明的生物参考区间适用于本实验室，建立的最大稀释倍数和CRR可为临床提供更好的质量保证。
      【关键词】 1,5-脱水葡萄糖醇；吡喃糖氧化酶法；方法学；性能评价；糖尿病
      【中图分类号】 R446.1 【文献标识码】 A 【文章编号】 1003—6350（2020）03—0281—03

Performance evaluation of serum 1,5-anhydroglucitol assay by pyranose oxidase.
CHEN Ying, LI Sha, SUOMing-huan, WANG Wei-jia. Department of Laboratory Medicine, Sun Yat-sen University Affiliated Zhongshan Hospital,Zhongshan 528403, Guangdong, CHINA
【Abstract】 Objective To evaluate analytical performance of serum 1,5-anhydroglucitol (1,5-AG) by pyranoseoxidase. Methods Precision, accuracy, anti-interference ability, analytical measure range (AMR), clinical reportablerange (CRR) and biological reference interval of serum 1,5-AG were evaluated according to EP document issued byClinical and Laboratory Standards Institute (CLSI) and related reference. Results The within-run and between-run pre-cision of low-level and high-level serum 1,5-AG were 1.58%, 0.76% and 3.37%, 1.22%, which were less than standard ofmanufacturer. The accuracy validation showed that the bias was 1.42% and 1.27%, which was less than the quality objec-tives for affiliated calibrators (10%). Anti-interference evaluation showed no significant interference at TG≤500 mg/dL,Bil≤50 mg/dL, Hb≤20 mg/dL, and VitC≤50 mg/dL. AMR validation showed that the best fit equation was linear equa-tion polynomial. There was linear relationship when the concentration of serum 1,5-AG was 0.16 μg/mL to 49.82 μg/mL.CRR level was 0.35 μg/mL to 1 594.24 μg/mL, and the maximum dilution of CRR was 32 times. Biological reference in-terval validation showed that the overall level of serum 1,5-AG in this study reference individuals conformed to the stan-dard of manufacturer for the population. Conclusion The analytical performance of serum 1,5-AG by pyranose oxi-dase basically met the needs of laboratory, which can provide reliable result. Biological reference that manufacturershave proclaimed is suitable for the laboratory. The establishment of the maximum dilution and CRR can provide betterquality assurance.
      【Key words】 1,5-anhydroglucitol; Pyranose oxidase; Methodology; Performance evaluation; Diabetes mellitus