Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay

Changseung Liu; Eunhye Choi; In Cheol Bae; Sang-Guk Lee; Jeong-Ho Kim

doi:10.3343/lmo.2017.7.2.59

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Liu, Choi, Bae, Lee, and Kim: Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay

Original Article

Lab Med Online 2017;7(2):59-65.

Published online: 17 April 2017

DOI: https://doi.org/10.3343/lmo.2017.7.2.59

Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay

Changseung Liu, M.D., Eunhye Choi, M.T., In Cheol Bae, M.T., Sang-Guk Lee, M.D., Jeong-Ho Kim, M.D.

Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea

Corresponding author: Sang-Guk Lee Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea Tel: +82-2-2228-2455, Fax: +82-2-364-1583, E-mail: comforter6@yuhs.ac

Received 17 May 20166 August 2016 Accepted 17 August 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Hemoglobin A1c (HbA1c) is considered a marker useful for the followup and diagnosis of diabetes and implies the importance of reliable assay methods that are traceable to a reference method. We evaluated analytical performance of a new high-performance liquid chromatography system for the HbA1c assay: D-100 from Bio-Rad Laboratories (USA).

Methods

We evaluated precision, linearity, and carry-over of D-100, according to the Clinical and Laboratory Standards Institute's guidelines. Comparative analysis of D-100 with Integra 800 (Roche Diagnostics, Germany) and Capillarys 3 (Sebia, France) was conducted. Additionally, we evaluated the throughput of the three instruments.

Results

Precision of low- and high-concentration controls in D-100 showed a CV of less than 1%. The linearity was excellent (R²=0.999) in the range of 3.51-18.7%, and carry-over was not observed. HbA1c results of D-100 (n=144) showed good correlation with those of Integra 800 (r=0.993) and Capillarys 3 (r=0.996). The % bias between D-100 and Integra 800 or Capillarys 3 was within the allowable range at all 3 medical decision levels (5.7%, 6.5%, and 10.0%). Elapsed time in the analysis of the first sample by D-100 was shorter than that of Integra 800 (2.4 vs. 11.1 minutes), but subsequent samples took more time (0.8 vs. 0.3 minutes per sample).

Conclusions

D-100 showed reliable analytical performance with good precision and linearity, minimal carry-over, and acceptable comparative characteristics relative to other instruments. D-100 is expected to be useful for clinical measurements of HbA1c for diabetes diagnosis and theranostics.

Keywords: Hemoglobin A1c, Bio-Rad D-100, Analytical performance

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Fig. 1.

Linearity of the HbA1c assay using D-100.

Fig. 2.

A Deming regression plot for D-100 and Integra 800 (A) and for D-100 and Capillarys 3 (B). Abbreviation: CI, confidence interval.

Fig. 3.

A Bland-Altman difference plot for D-100 and Integra 800 (A) and for D-100 and Capillarys 3 (B).

Table 1.

Precision of HbA1c measurements using D-100

Material	Mean HbA1c (%)	Coefficient of variation (%)
Material	Mean HbA1c (%)	Within-run	Between-run	Between-day	Within-device
Level 1	5.38	0.69	0.23	0.46	0.86
Level 2	9.87	0.59	0.30	0.45	0.68

Table 2.

Recovery of commercial HbA1c linearity materials tested on D-100

Level	Assigned value (%)	Measured value (%)					Recovery (%)
Level	Assigned value (%)	Repeat 1	Repeat 2	Repeat 3	Repeat 4	Mean	Recovery (%)
1	3.5	3.5	3.5	3.5	3.5	3.5	99.7
2	4.6	4.7	4.7	4.7	4.7	4.7	101.3
3	6.0	6.0	6.1	6.1	6.0	6.1	100.8
4	9.8	9.7	9.8	9.8	9.8	9.8	100.1
5	13.6	13.6	13.4	13.6	13.6	13.6	99.6
6	18.7	18.5	18.4	18.4	18.5	18.5	98.7

Table 3.

Comparison of HbA1c values obtained by means of D-100, Integra 800, and Capillarys 3 using Deming regression

Instruments	MDP	Slope (a)	Intercept (b)	Expected value	% bias	Allowable bias (%)	Interpretation
D-100 vs. Integra 800	5.7	0.95	0.25	5.67	0.6	3	Acceptable
	6.5	0.95	0.25	6.43	1.1	3	Acceptable
	10.0	0.95	0.25	9.76	2.4	3	Acceptable
D-100 vs. Capillarys 3	5.7	0.98	0.25	5.82	2.2	3	Acceptable
	6.5	0.98	0.25	6.61	1.7	3	Acceptable
	10.0	0.98	0.25	10.03	0.3	3	Acceptable

Abbreviation: MDP, medical decision point.

Table 4.

Analytical time of D-100, Integra 800, and Capillarys 3

	Initial sample	Following sample	Initial to continuous 10 samples	Initial to continuous 60 samples
Bio-Rad D-100 (min)	2.4	0.8	9.4	46.1
Roche Integra 800 (min)	11.1	0.3	13.9	31.3
Sebia Capillarys 3 (min)^∗	23.0^†	11.4^†	23.0^†	72.0
^∗Sebia Capillarys 3 processes samples.	12 samples as	s a unit; ^†Tim	me for measur	rement of 12

^∗ Sebia Capillarys 3 processes 12 samples as a unit;

^† Time for measurement of 12 samples.

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