Quality Control and the Task of Improving the Measurement of Glycated Hemoglobin A1c and Glycated Albumin Using Clinical Samples. A Report from The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes

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  • Mochizuki Mie
    Department of Pediatrics, University of Yamanashi The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Musha Ikuma
    Department of Pediatrics, Saitama Medical University The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Kobayashi Koji
    Department of Pediatrics, University of Yamanashi The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Suzuki Shigeru
    Department of Pediatrics, Asahikawa Medical University The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Kobayashi Kisho
    Kobayashi Children's Clinic The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Kikuchi Nobuyuki
    Department of Pediatrics, Yokohama Rosai Hospital The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Yokota Ichiro
    Department of Pediatrics, Shikoku Medical Center for Children and Adults The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Kawamura Tomoyuki
    Department of Pediatrics, Osaka City University The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Urakami Tatsuhiko
    Department of Pediatrics, Nihon University Hospital The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Kikuchi Toru
    Department of Pediatrics, Saitama Medical University The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Sugihara Shigetaka
    Department of Pediatrics, Tokyo Women's Medical University Medical Center East The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Sasaki Nozomu
    Department of Pediatrics, Saitama Medical University The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Matsuura Nobuo
    Department of Pediatrics, Bibai City Hospital The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT
  • Hoshino Tadao
    Institute of Biopathological Medicine
  • Amemiya Shin
    Department of Pediatrics, Saitama Medical University The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes, JSGIT

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Other Title
  • ヘモグロビンA1cとグリコアルブミンの実臨床検体による精度管理と課題．小児インスリン治療研究会報告

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Abstract

<p>We evaluated the quality control status of glycated hemoglobin A1c (HbA1c) and glycated albumin (GA) at The Japanese Study Group of Insulin Therapy for Childhood and Adolescent Diabetes. We used the absolute relative difference (ARD) between one centralized laboratory value and the values from four clinical samples at each Institute. The methods that each method used for the measurement of HbA1c and GA were investigated and we determined whether the measurement was conducted in-hospital. Additionally, for GA, the number of samples at each institution and the frequency of internal quality control by existing calibrators were investigated. HbA1c sample measurements were conducted in-hospital in 98 % of the cases and 86 % were measured using the HPLC method. For GA, 78 % of measurements were conducted in-hospital, and the frequency of quality control was 1.9 (0-6) times per month. The mean ARD of GA was 2.65 %, which was significantly higher than the mean ARD of HbA1c (1.91 %). The ARD of GA was higher in institutes with less frequent internal quality control and fewer samples. Both HbA1c and GA were well controlled in terms of accuracy, but it was considered important to ensure the frequency of internal quality control for GA measurement. The analysis of clinical specimens was useful for continuous external quality control.</p>

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