Divergence factor in HbAlc measurement with domestic and/or international standard material - Divergence factor between POCT HbAlc measurement DCA2000/DCA vantage and the domestic daily method used in Japan

Shuji Oguchi, Terumichi Nakagawa, Midori Ishibashi, Mitsuru Murata

Research output: Contribution to journalArticle

Abstract

We investigated the divergence factor between HbAlc measurement using DCA2000/Vantage (DCA) and the domestic daily method used in Japan referencing the KO 500 method, i.e., JSCC/JDS standard measurement. Calibration settings of the international standardization material and of DCA internal calibration material mostly resembled DCA measurement but measured 7 % to 10 % lower in relative percentage than the KO 500 method setting. KO500 chromatography recognized the peak of foreign substances not recognized by JDS Lot 4 in calibration of the international standardization material or of the DCA internal calibration material. The DCA divergence factor was thought to be caused by a difference in standard material composition or a difference in operation method separation capability. DCA showed a valid result by adopting calibration decided by the Japan Diabetes Society (JDS) and supplied the product based on JDS Lot 4 from July 2010.

Original languageEnglish
Pages (from-to)386-391
Number of pages6
JournalJournal of the Japan Diabetes Society
Volume55
Issue number6
Publication statusPublished - 2012 Jun

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Calibration
Japan
Chromatography

ASJC Scopus subject areas

  • Endocrinology
  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

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title = "Divergence factor in HbAlc measurement with domestic and/or international standard material - Divergence factor between POCT HbAlc measurement DCA2000/DCA vantage and the domestic daily method used in Japan",
abstract = "We investigated the divergence factor between HbAlc measurement using DCA2000/Vantage (DCA) and the domestic daily method used in Japan referencing the KO 500 method, i.e., JSCC/JDS standard measurement. Calibration settings of the international standardization material and of DCA internal calibration material mostly resembled DCA measurement but measured 7 {\%} to 10 {\%} lower in relative percentage than the KO 500 method setting. KO500 chromatography recognized the peak of foreign substances not recognized by JDS Lot 4 in calibration of the international standardization material or of the DCA internal calibration material. The DCA divergence factor was thought to be caused by a difference in standard material composition or a difference in operation method separation capability. DCA showed a valid result by adopting calibration decided by the Japan Diabetes Society (JDS) and supplied the product based on JDS Lot 4 from July 2010.",
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T1 - Divergence factor in HbAlc measurement with domestic and/or international standard material - Divergence factor between POCT HbAlc measurement DCA2000/DCA vantage and the domestic daily method used in Japan

AU - Oguchi, Shuji

AU - Nakagawa, Terumichi

AU - Ishibashi, Midori

AU - Murata, Mitsuru

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N2 - We investigated the divergence factor between HbAlc measurement using DCA2000/Vantage (DCA) and the domestic daily method used in Japan referencing the KO 500 method, i.e., JSCC/JDS standard measurement. Calibration settings of the international standardization material and of DCA internal calibration material mostly resembled DCA measurement but measured 7 % to 10 % lower in relative percentage than the KO 500 method setting. KO500 chromatography recognized the peak of foreign substances not recognized by JDS Lot 4 in calibration of the international standardization material or of the DCA internal calibration material. The DCA divergence factor was thought to be caused by a difference in standard material composition or a difference in operation method separation capability. DCA showed a valid result by adopting calibration decided by the Japan Diabetes Society (JDS) and supplied the product based on JDS Lot 4 from July 2010.

AB - We investigated the divergence factor between HbAlc measurement using DCA2000/Vantage (DCA) and the domestic daily method used in Japan referencing the KO 500 method, i.e., JSCC/JDS standard measurement. Calibration settings of the international standardization material and of DCA internal calibration material mostly resembled DCA measurement but measured 7 % to 10 % lower in relative percentage than the KO 500 method setting. KO500 chromatography recognized the peak of foreign substances not recognized by JDS Lot 4 in calibration of the international standardization material or of the DCA internal calibration material. The DCA divergence factor was thought to be caused by a difference in standard material composition or a difference in operation method separation capability. DCA showed a valid result by adopting calibration decided by the Japan Diabetes Society (JDS) and supplied the product based on JDS Lot 4 from July 2010.

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