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

Performance evaluation of serum 1,5-anhydroglucitol assay by pyranose oxidase

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0.16~49.82μg/mL范围内存在线性关系;CRR最大稀释倍数是32倍,范围为0.35~1594.24μg/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。

Objective To evaluate analytical performance of serum 1,5-anhydroglucitol(1,5-AG)by pyranose oxidase.Methods Precision,accuracy,anti-interference ability,analytical measure range(AMR),clinical reportable range(CRR)and biological reference interval of serum 1,5-AG were evaluated according to EP document issued by Clinical and Laboratory Standards Institute(CLSI)and related reference.Results The within-run and between-run precision 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 of manufacturer.The accuracy validation showed that the bias was 1.42%and 1.27%,which was less than the quality objectives 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 equation polynomial.There was linear relationship when the concentration of serum 1,5-AG was 0.16μg/mL to 49.82μg/mL.CRR level was 0.35μg/mL to 1594.24μg/mL,and the maximum dilution of CRR was 32 times.Biological reference interval validation showed that the overall level of serum 1,5-AG in this study reference individuals conformed to the standard of manufacturer for the population.Conclusion The analytical performance of serum 1,5-AG by pyranose oxidase basically met the needs of laboratory,which can provide reliable result.Biological reference that manufacturers have proclaimed is suitable for the laboratory.The establishment of the maximum dilution and CRR can provide better quality assurance.