Four International Societies published the statement that, for the standardization of hemoglobin Alc(HbAlc), analytical results should be presented in the both units of IFCC and NGSP. The Committee of Diabetes Mellitus Indices of JSCC was commented acceptance of this statement. The Committee on Standardization of Laboratory Testing for Diabetes Mellitus of JDS is now under working with a standpoint of acceptance of the two units.
The both committees started arrangement of circumstances for the standardization of HbAlc measurement in Japan. Thus, a guideline for reporting IFCC units and JDS units on measurement of HbAlc is needed for a practical purpose of manufacturers and end-users in Japan.
In the present guideline, the traceability chain being built up on the IFCC peptide mapping procedure as an anchor method, constitution of matrix reference materials for reference and working standards, master equations for the reporting the IFCC and JDS units and/or the IFCC and NGSP units, the criteria of specification of the master equations, and the control system of the HbAlc measurement in routine measurement procedures will be served.
The following studies are still remaining: to assign total Hb and HbAlc concentrations as the certified values, to determine the allowance and control limits of the IFCC units in a routine laboratory, to examine the reference intervals and clinical target values using the IFCC unit, to assess the reference system of HbAlc measurement the IFCC unit, and to educate the laboratory staffs, clinicians, and patients on the IFCC unit in the routine medical care.