迈瑞H50糖化血红蛋白分析仪精密度和可比性评估

doi:10.3969/j.issn.1673-8640.2017.03.014

摘要/Abstract

摘要：

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HbA_1c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。

关键词: 糖化血红蛋白, 糖尿病, 精密度, 可比性

Abstract:

Objective To evaluate the precision and comparability of Mindray H50 glycated hemoglobin A_1c （HbA_1c）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 HbA_1c 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（Y_H50=1.053 3X_G8-0.486 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 HbA_1c 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.

Key words: Glycated hemoglobin A_1c, Diabetes mellitus, Precision, Comparability

中图分类号:

R446.1

郭宗辉, 陈永强, 曾方银. 迈瑞H50糖化血红蛋白分析仪精密度和可比性评估[J]. 检验医学, 2017, 32(3): 214-218.

GUO Zonghui, CHEN Yongqiang, ZENG Fangyin. Precision and comparability assessment of Mindray H50 glycated hemoglobin A_1c analyzer[J]. Laboratory Medicine, 2017, 32(3): 214-218.

图/表 5

表1 HbA1c高、低值样本精密度结果（%）

HbA_1c	均值（%）	批内CV（95%CI）	批间CV	天间CV	总CV（95%CI）
低值	5.82	0.86（0.69~1.03）	1.55	0.00	1.72（1.55~2.23）
高值	11.66	0.34（0.26~0.43）	0.77	0.60	1.03（0.86~1.37）

图1 364例样本HbA1c双份测定偏差图注：X轴为每例样本2次测定结果的均值,Y轴为每例样本2次测定结果的差值

图2 H50与G8检测HbA1c的相关性注：Y=1.053 3X-0.486 7,r=0.998 4,P<0.001

图3 H50与G8 HbA1c测定结果的偏差图注：Y轴为检测偏差（H50-G8）,X轴为H50和G8的测定均值

表2 H50与G8在各HbA1c医学水平处的偏差

HbA_1c（%）	偏差（%）	标准误	95%CI（%）
4.0	-0.27	0.014	-0.30~-0.25
6.0	-0.17	0.009	-0.18~-0.15
6.5	-0.14	0.008	-0.16~-0.12
7.0	-0.11	0.007	-0.13~-0.10
9.0	-0.01	0.007	-0.02~0.01

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