1. New HPLC instrument performance evaluation in HbA 1c determination and comparison with capillary electrophoresis.
- Author
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Khashoggi H, Pignalosa S, Russo C, Pieri M, and Bernardini S
- Subjects
- Biomarkers blood, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 diagnosis, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 diagnosis, Glycated Hemoglobin metabolism, Humans, Hyperglycemia blood, Hyperglycemia diagnosis, Reproducibility of Results, Chromatography, High Pressure Liquid standards, Electrophoresis, Capillary standards, Glycated Hemoglobin analysis
- Abstract
Glycated hemoglobin (HbA
1c ) measurement provides the most important medium to long-term marker of time-averaged glycemic status. Its relationship to clinical outcome in diabetes has been convincingly demonstrated for both type 1 and type 2 diabetes. The main HbA1c measurement methods for clinical routine are as follows: ion-exchange chromatography; affinity chromatography, capillary electrophoresis, immunoassay and enzymatic methods. In this study, we evaluated the analytical performances of a new HPLC instrument (Tosoh HLC-723 G11 in the VAR mode) in HbA1c analysis and compared it with a capillary electrophoresis instrument (Sebia Capillarys 2 Flex Piercing). HbA1c analysis was performed in parallel by both methods for 250 samples randomly chosen from healthy and diabetic subjects at 'Tor Vergata' University Hospital of Rome. Tosoh HLC-723 G11 showed good reproducibility for 10 days both in quality controls and in samples analyzed (%CV < 2%). We found good linearity for HbA1c values ranging from 15 mmol/mol (3.5%) to 178 mmol/mol (18.5%), with a correlation coefficient R2 = 1. In a comparison between Tosoh HLC-723 G11 and Capillarys 2FP a good correlation (r = 0.99) was found; however, Tosoh HLC-723 G11 showed higher values in the low range of HbA1c and lower in the high range (Tosoh HLC-723 G11 = 4.3043 + 0.913 Capillarys 2FP; p < 0.001). Tosoh HLC-723 G11 showed good repeatability, reproducibility, accuracy and automated simplicity, and it seemed suitable for routine use in clinical chemistry laboratories.- Published
- 2018
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