Abstract
Purpose: Hemoglobin A1c (HbA1c) is an essential marker for assessment of glycemic control in diabetes patients. The aim of this study was to evaluate the agreement between different HbA1c methods. Methodology: We used blood samples to compare HbA1c results analyzed with Capillarys 3 Tera, Roche Tina-Quant HbA1c Gen 3, BioRad Variant II Turbo (3 sites), Mono S® and Abbott Architect enzymatic method. The comparisons were made as paired instrument comparisons with Capillarys 3 Tera. Results: The linear correlations between the HbA1c methods were as follows: Cobas 6000 = 0.982 x Capillarys 3 Tera + 0.975, R² = 0.994; Architect c8000 = 0.982 x Capillarys 3 Tera + 1.064, R² = 0.994; Mono S® = 0.916 x Capillarys 3 Tera + 3.397, R² = 0.965; BioRad Variant II Turbo = 0.923 x Capillarys 3 Tera + 4.062, R² = 0.990; Tosoh G8 = 0.963 x Capillarys 3 Tera + 3.895, R² = 0.996. Conclusions: The different instrument platforms showed the best agreement in the 50-70 mmol/mol interval. Above and below this range the methods separated into 2 groups, one consisting of Capillarys 3 Tera, Roche Tina-Quant and Abbott enzymatic method and the other group consisting of BioRad Variant II Turbo, Tosoh G8 and Mono S®.
Highlights
Hemoglobin A1c (HbA1c) is an important blood test for the diagnosis and monitoring of diabetes mellitus patients, providing information about the average blood glucose levels over the past 2 to 3 months
The samples had been stored at -70°C after the use in regular external quality assessment (EQA) schemes and had been measured with International Federation of Clinical Chemistry (IFCC) reference method (INSTAND, Germany) in addition to the Mono S® assigned values [9]
The quality goal for EQA was fulfilled for duplicate measurements for all 5 samples in relation to the IFCC reference method (Figure 4) and to the Mono S® procedure
Summary
Hemoglobin A1c (HbA1c) is an important blood test for the diagnosis and monitoring of diabetes mellitus patients, providing information about the average blood glucose levels over the past 2 to 3 months. Together with glucose it is used for glycemic control assessment of both type 1 and type 2 diabetes patients [1, 2]. The accuracy goal for HbA1c results in Equalis external quality assessment (EQA) scheme is that results should deviate less than 1.5 mmol/mol + 1.65 * 0.025 * the assigned HbA1c value. To be able to reach this accuracy it is important that the different methods in use provide test results without
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