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Evaluation of a reference material for glycated haemoglobin
C W Weykamp1, T J Penders, F A Muskiet
1Department of Clinical Chemistry, Queen Beatrix Hospital, Winterswijk, The Netherlands.
European Journal of Clinical Chemistry and Clinical Biochemistry : Journal of the Forum of European Clinical Chemistry Societies
|January 1, 1996
Summary
Lyophilized blood is a stable reference material for glycated haemoglobin (HbA1c) testing. This finding supports its use as calibrators and control materials for improved long-term diabetic control monitoring.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biotechnology
Background:
- Accurate measurement of glycated haemoglobin (HbA1c) is crucial for diabetes management.
- Standardized reference materials are needed to ensure consistency across different laboratory methods.
- Lyophilization is a potential method for preserving biological samples for diagnostic use.
Purpose of the Study:
- To evaluate lyophilized blood as a reference material for glycated haemoglobin (HbA1c) testing.
- To assess the stability and suitability of lyophilized blood according to International Federation of Clinical Chemistry (IFCC) criteria.
- To determine the impact of lyophilization on HbA1c measurement accuracy and reproducibility.
Main Methods:
- Ninety-two laboratories participated, utilizing eleven different analytical methods.
- Stability of lyophilized blood was tested after storage at 4°C, -20°C, and -84°C for up to 18 months.
- Methods included affinity chromatography, High-Performance Liquid Chromatography (HPLC), electrophoresis, and immunoassay.
- Matrix effects and inhomogeneity were assessed by comparing lyophilized samples with whole blood.
Main Results:
- No significant changes in glycated haemoglobin content were observed after one year of storage at 4°C across multiple methods.
- Stability was confirmed for up to 18 months at -84°C and -20°C for all tested methods.
- HPLC samples remained stable for 5 years at -20°C, and other methods for 5 years at 4°C.
- Lyophilization did not introduce matrix effects or inhomogeneity, with comparable mean HbA1c and reproducibility to whole blood.
- Vial filling precision showed a coefficient of variation of 0.59%.
Conclusions:
- Lyophilized blood is a suitable and stable reference material for glycated haemoglobin (HbA1c) calibrators and control materials.
- Its use can contribute to standardized interpretation of long-term diabetic control, especially when HbA1c values are assigned by HPLC.
- The findings support the adoption of lyophilized blood in routine clinical chemistry for diabetes monitoring.