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[Standardization of glycosylated hemoglobin in the context of the DAI study]
1Dipartimento di Scienze e Tecnologie Biomediche, Università degli Studi, Milano. andrea.mosca@unimi.it
Insights
External quality assessment of glycohemoglobin testing shows 64% of 85 centers align with the Diabetes Control and Complications Trial (DCCT) system. Method reproducibility requires improvement for better diabetes management.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diabetes Mellitus Diagnostics
Background:
- External quality assessment (EQA) is crucial for standardizing laboratory testing.
- Glycohemoglobin (HbA1c) measurement accuracy is vital for diabetes management and patient outcomes.
- The Diabetes Control and Complications Trial (DCCT) established a reference system for HbA1c measurement.
Purpose of the Study:
- To evaluate the performance of 85 antidiabetic centers in an EQA scheme for glycohemoglobin.
- To assess the alignment of participating laboratories with the DCCT-traceable target values.
- To identify areas for improvement in glycohemoglobin measurement techniques.
Main Methods:
- Utilized EQA materials prepared by an International Federation of Clinical Chemistry (IFCC) network laboratory.
- Assigned DCCT-traceable target values to control materials.
- Collected and analyzed glycohemoglobin measurement data from 85 antidiabetic centers.
Main Results:
- High-Performance Liquid Chromatography (HPLC) is the predominant method (75%), followed by immunochemical techniques (21%).
- 64% of centers demonstrated good alignment with the DCCT system.
- Method reproducibility, measured as coefficient of variation (CV), ranged from 3.7% to 5.8%.
Conclusions:
- While a majority of centers align with the DCCT system, overall glycohemoglobin measurement reproducibility needs enhancement.
- Standardization efforts through EQA are effective but require continuous improvement.
- Further optimization of analytical methods is recommended to improve diabetes care quality.
Abstract:
The results obtained from 85 antidiabetic centers enrolled in the DAI study are presented with regard to the external quality assessment scheme for glycohemoglobin. The materials have been prepared by a laboratory of the network of reference laboratories of the International Federation of Clinical Chemistry (IFCC). To each control a Diabetes Control and Complications Trial (DCCT) traceable target value was assigned. The High-Performance Liquid Chromatography (HPLC) methods for glycohemoglobin are used in 75% of the centers, the immunochemical techniques in 21% and less than 5% is using affinity chromatography based methods. The data collected from the laboratories who completed the set of measurements show that 64% of the centers are well aligned to the DCCT system. The reproducibility of the methods varied between 3.7 and 5.8% (as CV, %) and has to be improved.
