Development of hemoglobin A1c certified reference material by liquid chromatography isotope dilution mass spectrometry
| Autor: | Yang Yi, Jing Wang, Bin Yang, Liqing Wu, Jiaming Bi |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Glycated Hemoglobin
Reproducibility Chromatography fungi Reference Standards Isotope dilution Mass spectrometry Biochemistry High-performance liquid chromatography Mass Spectrometry Analytical Chemistry Dilution chemistry.chemical_compound Certified reference materials chemistry Diabetes Mellitus Humans Glycated hemoglobin Hemoglobin Chromatography High Pressure Liquid |
| Zdroj: | Analytical and Bioanalytical Chemistry. 403:549-554 |
| ISSN: | 1618-2650 1618-2642 |
| Popis: | We report the development of a National Institute of Metrology (NIM) hemoglobin A(1c) (HbA(1c)) 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 HbA(1c) 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 HbA(1c) CRM was expressed as the ratio of HbA(1c) 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 HbA(1c) measurement in China. |
| Databáze: | OpenAIRE |
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