Report of the Committee on Standardization of laboratory Testing Related to Diabetes Mellitus: HbA1c Number of JDS Lot 2 Determined by the IFCC HbA1c Working Group Reference laboratory Network

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  • Tominaga Makoto
    Department of Laboratory Medicine, Yamagata University School of Medicine
  • Makino Eiichi
    Department of Laboratory Medicine, Ehime University School of Medicine
  • Yoshino Gen
    Department of Laboratory Medicine, Toho University School of Medicine
  • Kuwa Katsuhiko
    Institute of Clinical Medicine, University of Tsukuba
  • Takei Izumi
    Department of Laboratory Medicine, Keio University School of Medicine
  • Aono Yukuko
    Clinical Laboratory, Tokyo University Hospital
  • Hoshino Tadao
    Institute of Biopathological Medicine
  • Shimatsu Akira
    Clinical Research Institute, Kyoto National Hospital
  • Sanke Tokio
    Department of Clinical Biology and Medicine, Wakayama Prefectural Medical School
  • Kuwajima Masamichi
    Department of Laboratory Medicine, The University of Tokushima, School of Medicine
  • Taminato Tomohiko
    Department of Laboratory Medicine, Kagawa University School of Medicine
  • Ono Junko
    Department of Laboratory Medicine, Fukuoka University School of Medicine

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Other Title
  • 糖尿病関連検査の標準化に関する委員会：ヘモグロビンＡ１ｃ標準物質ＪＤＳ　Ｌｏｔ２のＩＦＣＣ値について
  • イインカイ ホウコク トウニョウビョウ カンレン ケンサ ノ ヒョウジュンカ ニ カンスル イインカイ : ヘモグロビン A ₁ c ヒョウジュン ブッシツ JDS Lot 2 ノ IFCCチ ニ ツイテ
  • HbA<SUB>1</SUB>c Number of JDS Lot 2 Determined by the IFCC HbA<SUB>1</SUB>c Working Group Reference Laboratory Network
  • ヘモグロビンA<SUB>1</SUB>c標準物質JDS Lot 2のIFCC値について

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Abstract

The Japan Diabetes Society (JDS) Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus has established primary standard material (deeply frozen material, 5 levels, called JDS Lot 2) for measurement of hemoglobin A1c (HbA1c). Lot 2 has been distributed by HECTEF since March 1, 2001. The Lot 2 numbers have been carried over from the former JDS Lot 1 numbers. The HbA1c Standardization Working Group, on the other hand, was organized by the International Federation of Clinical Chemistry and LaboratoryMedicine (IFCC) to establish worldwide standardization of HbA1c. The Working Group proposed a highly specific method of measurement of HbA1c by an analytical chemistry procedure using endoproteinase Glu-C, and it was named the IFCC method. The Working Group also qualified10 laboratories throughoutthe world as reference laboratories to maintain the technical level of this method. The JDS Committee sent Lot 2 to reference laboratories to determine the IFCCnumber of HbA1c, and the results showed that the relationship between the JDS and the IFCC numbers was as follows:<BR>IFCC number (%) =1.068×JDS number (%)-1.741%.<BR>In conclusion, in the international standardization of HbA1c accordingto the IFCC method, the HbA1c numbers will significantly differ from the currentJDS numbers. Our Committee will discuss changing the JDS numbers to IFCC numberswith JDS members, and make a decision in the near future.

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