Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry-recommended reference measurement procedure and reference materials for glycated albumin determination
| Autor: | Keiko Yasukawa, Wataru Tani, Asako Sato, Tadao Hoshino, Takuji Kohzuma, Midori Ishibashi, Katsuhiko Kuwa, Makoto Tominaga, Mikiko Okahashi, Izumi Takei, Masao Umemoto |
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| Rok vydání: | 2015 |
| Předmět: |
Glycation End Products
Advanced Calibration curve Clinical Biochemistry 030209 endocrinology & metabolism 030204 cardiovascular system & hematology Isotope dilution Mass spectrometry Tandem mass spectrometry 03 medical and health sciences 0302 clinical medicine Japan Tandem Mass Spectrometry Diabetes mellitus medicine Humans Glycated Serum Albumin Serum Albumin Societies Medical Chromatography Isotope Chemistry Stable isotope ratio Albumin General Medicine Reference Standards medicine.disease Blood Chemical Analysis Chromatography Liquid |
| Zdroj: | Annals of Clinical Biochemistry: International Journal of Laboratory Medicine. 53:124-132 |
| ISSN: | 1758-1001 0004-5632 |
| Popis: | Background Glycated albumin is an intermediate glycaemic control marker for which there are several measurement procedures with entirely different reference intervals. We have developed a reference measurement procedure for the purpose of standardizing glycated albumin measurements. Methods The isotope dilution liquid chromatography/tandem mass spectrometry method was developed as a reference measurement procedure for glycated albumin. The stable isotopes of lysine and fructosyl-lysine, which serve as an internal standard, were added to albumin isolated from serum, followed by hydrogenation. After hydrolysis of albumin with hot hydrochloric acid, the liberated lysine and fructosyl-lysine were measured by liquid chromatography/tandem mass spectrometry, and their concentrations were determined from each isotope ratio. The reference materials (JCCRM611) for determining of glycated albumin were prepared from pooled patient blood samples. Results The isotope dilution–tandem mass spectrometry calibration curve of fructosyl-lysine and lysine showed good linearity (r = 0.999). The inter-assay and intra-assay coefficient of variation values of glycated albumin measurement were 1.2 and 1.4%, respectively. The glycated albumin values of serum in patients with diabetes assessed through the use of this method showed a good relationship with routine measurement procedures (r = 0.997). The relationship of glycated albumin values of the reference material (JCCRM611) between these two methods was the same as the relationship with the patient serum samples. Conclusion The Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry recommends the isotope dilution liquid chromatography/tandem mass spectrometry method as a reference measurement procedure, and JCCRM611 as a certified reference material for glycated albumin measurement. In addition, we recommend the traceability system for glycated albumin measurement. |
| Databáze: | OpenAIRE |
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