Development of hemoglobin A1c certified reference material by liquid chromatography isotope dilution mass spectrometry |
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Authors: | Bi Jiaming Wu Liqing Yang Bin Yang Yi Wang Jing |
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Institution: | (1) College of Science, Beijing University of Chemical Technology, Beijing, 100029, China;(2) Division of Biological, Energy and Environmental Measurement, National Institute of Metrology, Beijing, 100013, China; |
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Abstract: | We report the development of a National Institute of Metrology (NIM) hemoglobin A1c (HbA1c) certified reference material (CRM). Each CRM unit contains about 10 μL of hemoglobin. Both hemoglobin and glycated hemoglobin
were quantitatively determined by high-performance liquid chromatography (HPLC)–isotope dilution mass spectrometry (IDMS)
with synthesized VHLTPE and glycated VHLTPE as standards. The mass fraction of synthesized VHLTPE or glycated VHLTPE was also
quantitatively determined by HPLC-IDMS with NIM amino acid CRMs as standards. The homogeneity and stability of the CRMs were
examined with a commercial HbA1c analyzer based on the HPLC principle. Fifteen units were randomly selected for homogeneity examination, and statistical analysis
showed there was no inhomogeneity. Examination of the stability showed that the CRM was stable for at least 6 months at -80 °C.
Uncertainty components of the balance, amino acid purity, hydrolysis and proteolysis efficiency, method reproducibility, homogeneity,
and stability were taken into consideration for uncertainty evaluation. The certified value of NIM HbA1c CRM was expressed as the ratio of HbA1c to total hemoglobin in moles, and was (9.6 ± 1.9)% . The CRM can be used as a calibration or validation standard for clinical
diagnostics. It is expected to improve the comparability for HbA1c measurement in China. |
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