Why the study?
HbA1c measurement is useful for detection and follow-up of glycemic disorders, but there was no study evaluating HbA1c measurement on the Atellica CH 930 Analyzer.
Does the Atellica CH930 Analyzer provide comparable HbA1c measurements to capillary electrophoresis and HPLC in routine blood samples?
Does the Atellica CH930 Analyzer provide comparable HbA1c measurements to capillary electrophoresis and HPLC in routine blood samples?
The Atellica CH930 Analyzer demonstrates acceptable performance and strong correlation with established HPLC and capillary electrophoresis methods for HbA1c measurement.
Answers are grounded in this paper and cite their sources.
Supports interchangeable use of these HbA1c methods in routine labs; leaves open validation across hemoglobinopathy subgroups.
Aim HbA1c measurement is very useful for the follow-up and detection of glycemic disorder, since it is easier and faster test and is independent of the patient's fasting status. In this study, we aimed to perform the comparative evaluation of 3 different methods for HbA1c measurement including capillary electrophoresis, immunoturbidimetric assay and high-performance liquid chromatography-HPLC.Materials and methods This study comprised 134 leftover whole blood samples obtained from the subjects submitted for routine HbA1c testing. All blood samples were collected in EDTA-containing vacutainer tubes. The HbA1c levels were measured simultaneously using three different methods. Bias estimation, method agreement and concordance between the pairwise methods comparisons were evaluated by Bland–Altman plot and Passing–Bablok regression test.Results HbA1c levels ranged from 3.8% to 13.4% and measured by three different methods to make the comparison. The median values of samples based on immunoturbidimetric method (6.05%, IQR = 1.80) were higher than capillary electrophoresis method (5.90%, IQR = 1.80) and HPLC (5.85%, IQR = 1.80) method. The study group was classified into three subgroups based on the HbA1c levels measured with the HPLC method: Group 1 (n = 57) was composed of subjects with HbA1c levels less than 5.7%, Group 2 (n = 35) had HbA1c levels between 5.7% and 6.4%, Group 3 (n = 42) had HbA1c levels equal and more than 6.5%.Conclusion To our knowledge, there is no study evaluating the HbA1c measurement on the Atellica® CH 930 Analyzer. We compared the Atellica®CH930 Analyzer with both HPLC and capillary electrophoresis. The Atellica®CH930 Analyzer showed acceptable performance and a strong correlation with both mentioned methods.
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Oğuz et al. (2022) studied this question.
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