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Lee, Hong, and Cho: Comparison of HbA1c Analyzers: D-10, Variant II Turbo, Cobas Integra 800, and Afinion AS100
Original Article

Korean J Leg Med 2010;30(4):345-350.

Published online: 14 January 2010

DOI: https://doi.org/10.3343/kjlm.2010.30.4.345

Comparison of HbA1c Analyzers: D-10, Variant II Turbo, Cobas Integra 800, and Afinion AS100

Jin Young Lee, M.D.1, Ki Sook Hong, M.D.1, Sung Eun Cho, M.D.2

1Department of Laboratory Medicine, School of Medicine, Ewha Womans University, Seoul, Korea

2Eone Reference Laboratory, Seoul, Korea

Corresponding author: Ki Sook Hong, M.D. Department of Laboratory Medicine, Ewha Womans University Mokdong Hospital, 911-1 Mok-dong, Yangcheon-gu, Seoul 158-710, Korea Tel: +82-2-2650-2822, Fax: +82-2-2650-5091 E-mail: kshong@ewha.ac.kr

      Revised 16 October 200910 April 2010       Accepted 15 July 2010

Copyright © 2010 Korean Society for Legal Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background:

The purpose of this study was to evaluate the performance and agreement among HbA1c values measured using selected analyzers certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

Methods:

HbA1c determined using D-10 (Bio-Rad, USA), Variant II Turbo (Turbo; Bio-Rad, USA), Cobas Integra 800 (Integra; Roche, Switzerland) and Afinion AS100 (Afinion; Axis-Shield, Norway) were compared with each other. Precision and method comparisons with Deming regression were evaluated according to CLSI recommendations. We also compared the HbA1c values obtained with each analyzer using either IFCC or NGSP methods by correlation analysis and kappa statistics.

Results:

The repeatability and method/device precisions of D-10 and Afinion were acceptable. The correlation coefficients of HbA1c were 0.986 for D-10 vs. Afinion, 0.997 for D-10 vs. Turbo, 0.988 for D-10 vs. Integra, and 0.991 for Integra vs. Afinion. The average biases of HbA1c Afinion (IFCC) and HbA1c Integra (IFCC) against HbA1c D-10 (NGSP) were −1.90% and −1.79%, respectively. Kappa agreement statistics for the three diabetic control group HbA1c values of “less than 6.5%,” “6.5%-7.5%,” and “greater than 7.5%” for D-10 vs. Turbo, D-10 vs. Integra, and D-10 vs. Afinion were 0.872, 0.836, and 0.833, respectively.

Conclusions:

The strong correlations and good clinical agreements of HbA1c between each analyzer expressed in terms of either NGSP or IFCC-derived NGSP indicate that these analyzers can be used interchangeably.

Keywords: HbA1c, National Glycohemoglobin Standardization Program (NGSP), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), D-10, Afinion AS100, Cobas Integra 800, Variant II Turbo

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Fig. 1.
Comparison of the HbA1c method (A) using Afinion AS100 and D-10, which showed good correlation, but (B) with slight negative bias in Afinion AS100 HbA1c against D-10 evaluated according to CLSI EP9-A2 guidelines.
kjlm-30-345f1.tif
Fig. 2.
Comparison of HbA1c values using each NGSP method. (A) Variant II Turbo vs. D-10, (B) Cobas Integra 800 vs. D-10, and (C) Afinion AS100 vs. Cobas Integra 800, which all showed good correlation.
Abbreviation: NGSP, National Glycohemoglobin Standardization Program.
kjlm-30-345f2.tif
Fig. 3.
Comparison of HbA1c methods. (A) Afinion AS100 (IFCC) vs. D-10 (NGSP) and (B) Cobas Integra 800 (IFCC) vs. D-10 (NGSP), which show large negative differences (−1.90% and − 1.79%, respectively).
Abbreviations: NGSP, National Glycohemoglobin Standardization Program; IFCC, International Federation of Clinical Chemistry and Laboratory Medicine.
kjlm-30-345f3.tif
Table 1.
Characteristics of D-10, Variant II Turbo, Cobas Integra 800, and Afinion AS100 HbA 1c analyzers
  Manufacturer Principle Standardization
D-10 Bio-Rad HPLC NGSP certified/traceable to IFCC reference method
Variant II Turbo Bio-Rad HPLC NGSP certified
Cobas Integra 800 Roche Homogeneous immunoassay NGSP certified/IFCC standardized
Afinion AS100 Axis Shield Boronate affinity assay NGSP certified/traceable to IFCC reference method

Abbreviations: NGSP, National Glycohemoglobin Standardization Program; IFCC, International Federation of Clinical Chemistry.

Table 2.
Repeatability, device/method precision, and between-day precision of D-10 and Afinion AS100 HbA1c analyzers evaluated by CLSI EP5-A2
HbA1c analyzers D-10 Afinion AS100
Control HbA1c (%) 5.3-6.5 8.8-11.0 5.5-6.7 7.1-8.7
Mean HbA1c (%) 5.92 10.27 5.94 7.79
Repeatability (Within-run precision)        
User SD 0.055 0.042 0.099 0.085
User variance 0.0030 0.0018 0.0098 0.0073
Performance claim SD 0.1 0.1 0.1 0.1
Performance variance 0.01 0.01 0.01 0.01
Degrees of freedom (R) 40 40 40 40
(I) (User variance/Claim variance) ∗R 12.0 7.0 39.0 29.0
(II) Critical Chi-square 55.8 55.8 55.8 55.8
Results Accepted Accepted Accepted Accepted
Claim rejected (I>II)        
Claim accepted (I≤II)        
Device/method precision        
User SD 0.078 0.071 0.092 0.083
User variance 0.0061 0.0051 0.0084 0.0068
Performance claim SD 0.1 0.1 0.1 0.1
Performance variance 0.01 0.01 0.01 0.01
Degrees of freedom (R) 28 25 36 35
(I) (User variance/Claim variance) ∗R 17.0 12.7 30.2 23.8
(II) Critical Chi-square 41.3 37.7 51.0 49.3
Results Accepted Accepted Accepted Accepted
Claim rejected (I>II)        
Claim accepted (I≤II)        
Between-day precision (CV, %) 1.14 0.63 1.00 0.72
Table 3.
Agreement between HbA1c analyzers according to the three HbA1c levels
HbA1c analyzers HbA1c (%) Total (N=40) Kappa statistics with D-10
<6.5 6.5-7.5 >7.5
D-10 15 4 21 40 -
Variant II Turbo 16 5 19 40 0.872
Cobas Integra 800 16 7 17 40 0.836
Afinion AS100 16 6 18 40 0.833
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