Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Comparison of $HbA_{1c}$ Analyzers: D-10, Variant II Turbo, Cobas Integra 800, and Afinion AS100

  • Lee, Jin-Young (Department of Laboratory Medicine, School of Medicine, Ewha Womans University) ;
  • Hong, Ki-Sook (Department of Laboratory Medicine, School of Medicine, Ewha Womans University) ;
  • Cho, Sung-Eun (Eone Reference Laboratory)
  • Received : 2009.10.16
  • Accepted : 2010.07.15
  • Published : 2010.08.31
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Abstract

Background : The purpose of this study was to evaluate the performance and agreement among $HbA_{1c}$ 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 : $HbA_{1c}$ 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 $HbA_{1c}$ 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 $HbA_{1c}$ 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 $HbA_{1c}$ Afinion (IFCC) and $HbA_{1c}$ Integra (IFCC) against $HbA_{1c}$ D-10 (NGSP) were -1.90% and -1.79%, respectively. Kappa agreement statistics for the three diabetic control group $HbA_{1c}$ 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 $HbA_{1c}$ between each analyzer expressed in terms of either NGSP or IFCC-derived NGSP indicate that these analyzers can be used interchangeably.

배경 : National Glycohemoglobin Standardization Program (NGSP)법 인증을 받거나 International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) 표준화를 따르는 $HbA_{1c}$ 측정기기들의 검사 수행능력을 비교 평가하였다. 방법 : D-10 (Bio-Rad, USA), Variant II Turbo (Turbo; Bio-Rad, USA), Cobas Integra 800 (Integra; Roche, Switzerland)과 Afinion AS100 (Afinion; Axis-Shield, Norway)을 서로 비교하였다. CLSI 권고에 따라 정밀도 검증 및 검사 방법 비교를 하였고, 카파 통계를 이용하여 일치도 분석을 하였다. 결과 : D-10과 Afinion의 재현성과 방법/장비 정밀도는 적합하였고, D-10과 Afinion, D-10과 Turbo 및 D-10과 Integra의 상관계수는 각각 0.986, 0.997 및 0.988이었다. Integra와 Afinion의 상관계수는 0.991이었다. D-10 (NGSP)에 비해 Afinion (IFCC) 및 Integra (IFCC) $HbA_{1c}$값의 평균 오차는 각각 -1.90%, -1.79%이었다. $HbA_{1c}$ 측정값을 당뇨병 진단 기준에 의한 분류에 의하여 '6.5% 미만', '6.5-7.5%' 및 '7.5 이상' 세 군으로 나누었을 때, D-10과 Turbo, D-10과 Integra 및 D-10과 Afinion의 카파 통계량은 각각 0.872, 0.836 및 0.833이었다. 결론 : 각 기기들의 NGSP $HbA_{1c}$값 사이에 높은 상관성과 일치도를 보였고, NGSP $HbA_{1c}$값과 IFCC-변환 NGSP $HbA_{1c}$값 사이의 호환성을 확인할 수 있었다.

Keywords

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