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Committee on the Standardization of Diabetes-Related Laboratory Testing

Chairman: Atsunori Kashiwagi
Takashi Kadowaki, Masakazu Haneda, Hajime Nawata, Hiroshi Ito, Makoto Tominaga, Shinichi Oikawa, Mitsuhiko Noda, Takahiko Kawamura, Tokio Sanke, Mitsuyoshi Namba, Mitsuru Hashiramoto, Takayuki Sasahara (Secretary of the Committee: Yoshihiko Nishio)

The committee was inaugurated in 1993 as the Committee for GHb Standardization and, in 1998, it was succeeded by the Committee on the Standardization of Diabetes-Related Laboratory Testing, playing a large role in the standardization of hemoglobin A1c and accuracy control. The Committee on the Standardization of Diabetes-Related Laboratory Testing has now been reorganized, and issues including standardization of HbA1c and insulin measurement have been identified for the Committee’s attention.

At present the question of international standardization of HbA1c has arisen as a particularly important matter for consideration. The American Diabetes Association (ADA), European Association for the Studies of Diabetes (EASD), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and International Diabetes Federation (IDF) have jointly issued a consensus statement, and the Japan Diabetes Society is also studying their recommendations. The Committee has formulated an official view and will present a report to the Board of Directors.

The outline of the Committee’s recommendations is as follows: (1) standardize the HbA1c value as the glycosylated amount of hemoglobin β chain N terminal valine; (2) the HbA1c measurement system including reporting of the measured value should be standardized internationally, with the IFCC method as the standard measurement system; and (3) reporting of HbA1c measured values in Japan will use the JDS value (%) as the index for diabetes control used hitherto, in conjunction with the IFCC value. However, to avoid confusion in future, it is necessary to ensure that the notation conforms to the international standard.

In addition to the currently standard HPLC (high performance liquid chromatography) method, TIA (turbidimetric immunoassay) and the enzymatic method using antibodies that specifically identify glycosylation of hemoglobin β chain N terminal valine are being used for measurement of HbA1c. The Japan Diabetes Society (JSA) has examined differences in measured values using these measuring methods, differences between facilities, problems with reference materials, problems with notation of measured values and other issues, and has agreed to undertake standardization jointly with the Japanese Society of Laboratory Medicine (JSLM), Japan Society of Clinical Chemistry (JSCC), Japanese Committee for Clinical Laboratory Standards (JCCLS), Japan Society for Clinical Laboratory Automation (JSCLA), Japanese Association of Medical Technologists (JAMT) and other related associations.

The Committee will endeavor, after seeking the approval of the Board of Directors, to hold discussions with testing equipment manufacturers and reagent manufacturers, gain the understanding of the Japan Diabetes Society and medical practitioners such as doctors, nurses, laboratory technicians and pharmacists, and then conduct a range of activities designed to educate the public about the issues involved.

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日本イーライリリー株式会社
ノボノルディスクファーマ株式会社
サノフィ株式会社
小野薬品工業株式会社
武田薬品工業株式会社