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The Hemo One Autoanalyzer for Glycated Hemoglobin Assay
Krizia Pocino1, Rossana Molinario2, Rocco Manieri2
1Institute of Clinical Biochemistry, Catholic University of Sacred Heart, Rome, Italy and krizia.pocino@gmail.com.
Laboratory Medicine
|April 13, 2016
Summary
Ion-exchange HPLC and immunoturbidimetry are equivalent methods for measuring glycated hemoglobin (HbA1c), crucial for diabetes diagnosis and management. Both accurately reflect long-term blood glucose control.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diabetes Diagnostics
Background:
- Glycated hemoglobin (HbA1c) is a key marker for long-term blood glucose control in diabetes management.
- Clinical laboratories are essential for diabetes diagnosis and monitoring.
- Discrepancies in HbA1c results arise from various analytical methods, necessitating standardized reference methods like IFCC's HPLC-MS/CE.
Purpose of the Study:
- To compare the performance of two routine HbA1c measurement methods: ion-exchange HPLC and immunoturbidimetry.
- To evaluate the clinical utility of these routine methods against established standards.
Main Methods:
- Utilized Tosoh G8 HPLC analyzer and Hemo One autoanalyzer for HbA1c testing.
- Analyzed 100 blood specimens with HbA1c concentrations ranging from 4.3% to 14.7% (23.5–137 mmol/mol).
Main Results:
- Demonstrated high concordance between the ion-exchange HPLC and immunoturbidimetric methods.
- Achieved a Kappa value of 0.828, indicating excellent agreement between the two techniques.
Conclusions:
- Validated the immunoturbidimetric method for HbA1c measurement, showing its equivalence to the reference method.
- Confirmed that both ion-exchange HPLC and immunoturbidimetry are reliable for diabetes diagnosis and therapeutic monitoring.
