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Standardization and analytical goals for glycated hemoglobin measurement
Clinical Chemistry and Laboratory Medicine
|June 5, 2013
Summary
Establishing reliable glycated hemoglobin (HbA1c) measurements is vital for diabetes care. Analytical goals must align with assay specificity and traceability to the International Federation of Clinical Chemistry (IFCC) reference system for accurate global monitoring.
Area of Science:
- Clinical Chemistry
- Diabetes Diagnostics
- Laboratory Medicine
Background:
- Glycated hemoglobin (HbA1c) is essential for diagnosing and monitoring diabetes.
- Global standardization of HbA1c measurements is critical for reliable patient care.
- The International Federation of Clinical Chemistry (IFCC) established a reference measurement system for HbA1c.
Purpose of the Study:
- To emphasize the importance of analytical goals for clinically reliable HbA1c measurements.
- To highlight the dependence of analytical goals on assay specificity and units of measurement (IFCC vs. NGSP).
- To recommend analytical goals derived from biological variability for IFCC-aligned assays.
Main Methods:
- Defining the measurand based on the stable adduct of glucose to hemoglobin.
- Establishing traceability of HbA1c results to the IFCC reference system.
- Utilizing biological variability studies to derive analytical goals for IFCC-aligned assays.
Main Results:
- Allowable analytical goals for HbA1c assays are contingent upon their specificity and the units used (mmol/mol or %).
- Assays with IFCC-defined selectivity require analytical goals based on biological variability.
- Different calibration hierarchies, like NGSP-aligned assays, necessitate distinct analytical goals, potentially from clinical outcome data.
Conclusions:
- Analytical goals must be tailored to the specific HbA1c assay's calibration and selectivity.
- Performance evaluation of commercial HbA1c assays and clinical laboratories should use appropriate, system-specific analytical goals.
- Ensuring traceability and appropriate analytical goals are paramount for accurate global diabetes management.
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