迈瑞H50糖化血红蛋白分析仪精密度和可比性评估

Precision and comparability assessment of Mindray H50 glycated hemoglobin A_(1c) analyzer

目的评估迈瑞H50糖化血红蛋白分析仪(简称H50)的精密度和方法间的可比性。方法依据美国临床实验室标准化协会(CLSI)EP5-A2和EP9-A2文件对H50的精密度进行评价,同时与TOSOH HLC-723 G8糖化血红蛋白分析仪(简称G8)进行比对。结果 H50测定糖化血红蛋白(HbA_(1c))高、低值临床样本的批内、批间、天间和总精密度[以变异系数(CV)表示]分别为0.34%、0.77%、0.60%、1.03%和0.86%、1.55%、0.00%、1.72%,与G8具有良好的可比性(Y_(H50)=1.053 3X_(G8)-0.486 7,r=0.998 4),在Hb A1c水平分别为4.0%、6.0%、6.5%、7.0%和9.0%时与G8的绝对偏差[95%可信区间(CI)]分别为-0.27%(-0.30%^-0.25%)、-0.17%(-0.18%^-0.15%)、-0.14%(-0.16%^-0.12%)、-0.11%(-0.13%^-0.10%)、-0.01%(-0.02%~0.01%)。结论 H50的精密度良好,与G8的检测结果具有可比性,能满足糖尿病诊断和监测的要求。

Objective To evaluate the precision and comparability of Mindray H50 glycated hemoglobin A1c(HbA1c)analyzer. Methods According to the Clinical and Laboratory Standards Institute(CLSI) EP5-A2 and EP9-A2,the precision and comparability of H50 were evaluated and compared with TOSOH HLC-723 G8 analyzer.Results The within-run,between-run,inter-day and total precisions [coefficients of variation(CV)] for clinical samples with high and medium values of HbA1c were 0.34%,0.77%,0.60%,1.03% and 0.86%,1.55%,0.00%,1.72%,respectively. There was a good comparability between H50 and G8(YH50=1.053 3XG8-0.486 7,r=0.998 4).The biases [95% confidence interval(CI)] were -0.27%(-0.30%--0.25%),-0.17%(-0.18%--0.15%),-0.14%(-0.16%--0.12%),-0.11%(-0.13%--0.10%),-0.01%(-0.02%-0.01%)at different HbA1c levels of 4.0%,6.0%,6.5%,7.0% and 9.0%. Conclusions H50 has a good precision and shows a correlation with G8,and it meets the requirements of the diagnosis and glucose monitoring for diabetes mellitus.