酶法测定糖化血清蛋白的初步评价

Primary Assessment of Enzymatic Method for Glycated Serum Proteins

目的初步评价酮化氨基酸氧化酶法测定糖化血清蛋白(GSP)的临床应用性能。方法依据美国临床实验室标准化委员会颁布的《定量临床检验方法的初步评价;批准指南(EP10-A)》提供的方法,按特定的顺序连续5天测定高、中、低浓度质控品中的GSP,对酮化氨基酸氧化酶法测定GSP的方法进行初步评价。结果当质控品中的GSP浓度分别为186.5μmol/L、388.5μmol/L、590.5μmol/L时,其测定的回归方程为y=1.01x-2.80,相关系数r2=0.9994;绝对偏差分别是-0.1μmol/L、-8.2μmol/L、8.8μmol/L,总不精密度分别是1.31%、1.35%、0.67%。结论酮化氨基酸氧化酶法测定糖化血清蛋白的检测性能符合临床应用要求。

Objective To evaluate the GlyPro method for glycated serum proteins （GSP）. Methods In accordance with the NCCLS Document EP10-A, preliminary evaluation of the Enzymatic method for GSP was made on controls at high, middle and low concentrations for a period of 5 days. Results When the controls of GSP were 186.5μmol/L, 388.5μ mol/L, 590.5μmol/L, the return equation was y =1.01x - 2.80, with rE = 0.9994. Bias were -0.1μmol/L, -8.2μmol/L, 8.8μmoFL, with imprecisions at 1.31%, 1.35%, 0.67%. Conclusion The performance of the GlyPro method for GSP was up to the clinical applicable requests.