Precision and comparability assessment of Mindray H50 glycated hemoglobin A1c analyzer

doi:10.3969/j.issn.1673-8640.2017.03.014

Abstract

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

CLC Number:

R446.1

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.

Figures/Tables 5

References 17

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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）

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）

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

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