Evaluation on the analytical performance of capillary electrophoresis for the determination of HbA1c

doi:10.3969/j.issn.1673-8640.2015.02.019

Abstract

Abstract: Objective

To evaluate the precision, accuracy, linearity and anti-interference ability of capillary electrophoresis (CE) for the determination of hemoglobin A_1c (HbA_1c),and compare it with high performance liquid chromatography (HPLC).

Methods

Samples were collected according to each evaluation protocol. Samples were determined by SEBIA CAPILLARYS^TM 2 Flex Piercing HbA_1c analyzer (CE method), ARKRAY HA-8160 automatic HbA_1c analyzer (HPLC) and IFCC reference method. Statistical analysis and linear regression analysis were performed by SPSS 19.0.

Results

The impression at common HbA_1c levels (4.91%-9.67%) was <2%. The CE method and IFCC reference method showed good correlation (R²=0.993). The linearity was good (R²= 0.995) from HbA_1c 5.0% to 17.6%. The results were not significantly influenced by carbamylated hemoglobin, labile HbA_1c, bilirubin, chylomicron and so on (absolute bias ≤0.5%). SEBIA and HA-8160 showed good correlation (R²=0.993).

Conclusions

The precision, accuracy, linearity and anti-interference ability of SEBIA can meet the requirement of routine HbA_1c determination in clinical laboratories.

Key words: Hemoglobin A1c, Capillary electrophoresis, High performance liquid chromatography

CLC Number:

R446.1

LI Qing, LIU Wenbin, JIN Zhonggan, TANG Liping, WANG Meijuan, OU Yuanzhu, YU Xiaoxuan, JU Yi. Evaluation on the analytical performance of capillary electrophoresis for the determination of HbA_1c[J]. Laboratory Medicine, 2015, 30(2): 181-184.

Figures/Tables 4

样本	$x ?$	s	CV
S1	4.91	0.08	1.62
S2	6.22	0.08	1.22
S3	7.46	0.06	0.77
S4	9.67	0.10	1.09

样本	$x ?$	s	CV
S1	4.91	0.08	1.62
S2	6.22	0.08	1.22
S3	7.46	0.06	0.77
S4	9.67	0.10	1.09

样本浓度范围	氨甲酰化血红蛋白	不稳定HbA_1c	胆红素
4.6~5.0	0.15(0.05~0.4)	0.09(0.00~0.20)	0.10(0.00~0.20)
5.9~6.4	0.20(0.00~0.50)	0.04(0.00~0.10)	0.10(0.05~0.20)
8.4~8.7	0.10(0.05~0.15)	0.18(0.05~0.30)	0.08 (0.00~0.20)
样本浓度范围	乳糜	总血红蛋白浓度	HbF
4.6~5.0	0.05(0.00~0.10)	0.05(0.00~0.10)	0.25(0.20~0.30)
5.9~6.4	0.05(0.00~0.15)	0.06(0.00~0.15)	0.18(0.05~0.30)
8.4~8.7	0.05(0.00~0.10)	0.15(0.10~0.25)	0.32(0.15~0.40)

[1]	SACKS DB, ARNOLD M, BAKRIS GL, et al.Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus[J]. Diabetes Care,2011, 34(6): e61-e99.
[2]	JOHN WG, UK Department of Health Advisory Committee or Diabetes. Use of HbA1c in the diagnosis of diabetes mellitus in the UK. The implementation of World Health Organization guidance 2011[J]. Diabet Med,2012, 29(11): 1350-1357.
[3]	American Diabetes Association.Standards of medical care in diabetes--2014[J]. Diabetes Care,2014, 37(Suppl 1): S14-S80.
[4]	JEPPSSON JO, KOBOLD U, BARR J, et al.Approved IFCC reference method for the measurement of HbA1c in human blood[J]. Clin Chem Lab Med, 2002, 40(1): 78-89.
[5]	WEYKAMP C, WAENINK-WIEGGERS HW, KEMNA E, et al.HbA1c: performance of the Sebia Capillarys 2 Flex Piercing[J]. Clin Chem Lab Med,2013, 51(6): e129-e131.

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Evaluation on the analytical performance of capillary electrophoresis for the determination of HbA_1c

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