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International co-validation of glycated hemoglobin A1c certified reference materials
Chengxiang Ning1, Ji-Seon Jeong2, Tomoya Kinumi3
1Center for Advanced Measurement Science, National Institute of Metrology, Beijing, 100029, China.
Insights
International metrology institutes successfully co-validated glycated hemoglobin A1c (HbA1c) certified reference materials (CRMs). This ensures accurate and comparable HbA1c measurements for diabetes diagnosis and management.
Area of Science:
- Clinical Chemistry
- Metrology
- Analytical Chemistry
Background:
- Accurate glycated hemoglobin A1c (HbA1c) quantification is crucial for diagnosing and managing diabetes.
- Certified Reference Materials (CRMs) are vital for ensuring the accuracy and comparability of HbA1c measurements.
- International collaboration among National Metrology Institutes (NMIs) is key to establishing reliable measurement standards.
Purpose of the Study:
- To conduct an international co-validation of HbA1c CRMs.
- To assess the homogeneity and stability of candidate HbA1c reference materials.
- To verify the accuracy of HbA1c quantification methods used by participating NMIs.
Main Methods:
- Development and supply of candidate reference materials (RMs) including VHLTPE, glycated VHLTPE, and two levels of HbA1c by NIM.
- Homogeneity and stability assessments of the candidate RMs.
- Quantification of hexapeptides and HbA1c using isotope dilution mass spectrometry (IDMS) by NIM, KRISS, and NMIJ.
Main Results:
- NIM confirmed the homogeneity and stability of the developed reference materials.
- All participating NMIs demonstrated good agreement with certified values for hexapeptides in solution and HbA1c in a matrix, indicated by En values < 1.
- Successful co-validation of HbA1c CRMs was achieved among NIM, KRISS, and NMIJ.
Conclusions:
- The international co-validation confirms the reliability of the certified values for HbA1c CRMs.
- The validated CRMs will enhance the accuracy and comparability of HbA1c measurements globally.
- This collaborative effort strengthens metrological traceability for clinical diagnostic testing.
Abstract:
Accurate quantification of glycated hemoglobin A1c (HbA1c) is essential for the diagnosis and glycemic control in diabetic patients. The validation of HbA1c certified reference material (CRM) enhances the accuracy and comparability of HbA1c measurements. An international co-validation of HbA1c CRMs was conducted among the National Institute of Metrology, P.R. China (NIM), the Korea Research Institute of Standards and Science (KRISS), and the National Metrology Institute of Japan (NMIJ). Candidate reference materials (RMs) of VHLTPE, glycated VHLTPE, and two levels of HbA1c were developed and supplied by NIM. NIM investigated the homogeneity and stability of these materials, finding no inhomogeneity and confirming stability throughout the co-validation period. Isotope dilution mass spectrometry was employed for the quantitation of both hexapeptides in solution and HbA1c in a matrix. All three national metrology institutes (NMIs) were involved in the quantification of hexapeptides in solution, whereas only NIM and KRISS were involved in the quantification of HbA1c in the matrix. En values for both hexapeptides and HbA1c in the matrix were calculated, all being less than 1, indicating good agreement with the certified values. The successful co-validation of these CRMs demonstrates the reliability of the certified values, thereby benefiting the accuracy and comparability of HbA1c measurements.
