Related Experiment Videos
[Comparison of HbA1c analyzers: D-10, Variant II Turbo, Cobas Integra 800, and Afinion AS100]
Jin Young Lee1, Ki Sook Hong, Sung Eun Cho
1Department of Laboratory Medicine, School of Medicine, Ewha Womans University, Seoul, Korea.
Insights
Selected HbA1c analyzers show strong correlations and good clinical agreement, indicating they can be used interchangeably for accurate diabetes monitoring. This evaluation ensures reliable hemoglobin A1c testing across different devices.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diabetes Diagnostics
Background:
- Hemoglobin A1c (HbA1c) is a critical marker for diabetes management.
- Standardization of HbA1c assays is essential for accurate patient care.
- Evaluating the performance of different HbA1c analyzers is crucial for clinical laboratories.
Purpose of the Study:
- To assess the performance and agreement of HbA1c measurements from multiple NGSP-certified and IFCC-standardized analyzers.
- To compare the accuracy and precision of D-10, Variant II Turbo, Cobas Integra 800, and Afinion AS100 systems.
- To determine the interchangeability of these devices for clinical use.
Main Methods:
- Comparative analysis of HbA1c values from four different analyzers (D-10, Turbo, Integra, Afinion).
- Evaluation of precision and method comparisons using Deming regression and CLSI guidelines.
- Correlation analysis and kappa statistics were employed to assess agreement between IFCC and NGSP methods.
Main Results:
- Repeatability and precision were acceptable for D-10 and Afinion analyzers.
- High correlation coefficients (0.986-0.997) were observed between analyzers.
- Kappa statistics indicated good clinical agreement (0.833-0.872) for diabetic control groups.
Conclusions:
- The evaluated HbA1c analyzers demonstrate strong correlations and good clinical agreement.
- Interchangeability of these analyzers is supported when results are expressed using NGSP or IFCC-derived NGSP units.
- These findings support the reliable use of these devices in routine clinical practice for HbA1c testing.
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.
Related Concept Videos
01:24Automated Microbial Diagnostics
01:20Capillary Electrophoresis: Instrumentation