Abstract
Following the international standardization of the HbA1c levels, the Japan Diabetes Society (JDS) adopted a transition from the JDS values to the National Glycohemoglobin Standardization Program (NGSP) values in April 1, 2012. A survey of the current situation and operating conditions of the HbA1c levels as the NGSP values was conducted in June 2013 for the purpose of considering whether the transition to the NGSP values had been carried out smoothly before introducing the new system into practice. A total of 233 medical facilities with diabetes-related specialists and three major private laboratory facilities participated in this survey. The assay methods employed in this analysis included the HPLC method (88.1 %), immunological methods (9.3 %) and enzymatic method (2.5 %). The samples were adjusted using hemolysis liquids at three levels, for a coefficient of variation (CV) of the HbA1c level as the NGSP value of 2.3~3.0 %, 4.0~5.1 % and 3.7~4.9 %. Overall, the CV was 2.4~3.3 %, which was considered to be clinically acceptable. Furthermore, the NGSP value was used at 99.7 % of the participating medical facilities, and the patients were informed of the HbA1c testing results based on solely the NGSP values at more than half of the medical facilities. Therefore, the transition from the HbA1c JDS value to the NGSP value was considered to have been achieved smoothly.
