Abstract
Committee on JSCC and JDS has been promoting standardization activities of HbA1c measurement. Commutabilityo f measuredv alues of HbA1icn clinical laboratoryi s maintainedb y using the referencem aterial of JDS in Japan.T o standardizeH bA1mc easurement, IFCC WG established reference measurement procedure (RMP) using HPLC-CE or HPLC-ESI/-MS after protease hydration against specified? A-N-fructosyl-hemoglobin as measurand. Furthermore, international harmonization must be needed for HbA1c measurements. Committee on Diabetes Mellitus Indices of JSCC project cooperated with JDS has established JSCC reference measurement system for HbA1c measurement traceable to IFCC RMP and IFCC primary calibrator. JSCC RMP as reference method uses a HPLC method based on KO500 procedure presented by Hoshino and his colleagues. The KO500 procedure defines? A-N-mono-fructosyl-hemoglobin as measurand. To maintain reliability and commutability of HbA1c measurement in national and international standardization, a guideline of reference laboratory (RL) network system is constituted. The RL is responsible to perform assigned values of matrix reference materials, performance evaluation of routine measurement procedures, and target values of external quality assessment in proficiency testing. And also the RLs are committed to IFCC reference network for global harmonization activity. In RLs, the specification and standard for requirement of RL are specified as the Glycohemoglobin Standardization System in Japan.
