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Original Articles

Evaluation of GHb Assays in France by National Quality Control Surveys

  1. Philippe Gillery, MD, PHD,
  2. Gilles Dumont, PHD and
  3. Anne Vassault, PHD
  1. Central Laboratory of Biochemistry, Robert Debré Hospital, Centre Hospitalier Universitaire Reims, France
  2. Laboratory of Biochemistry A and Société Française de Biologie Clinique, Necker-Enfants Malades Hospital Paris, France
  1. Address correspondence and reprint requests to Prof. Philippe Gillery, Laboratoire Central de Biochimie, Hopital Robert Debré CHU Reims, Avenue du Général Koenig, F-51092 Reims Cedex, France. E-mail: gillery{at}infobiogen.fr
Diabetes Care 1998 Feb; 21(2): 265-270. https://doi.org/10.2337/diacare.21.2.265
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Abstract

OBJECTIVE To evaluate the state of the art concerning GHb assays through analysis of a large-scale quality control survey and to compare the results with those of previous surveys.

RESEARCH DESIGN AND METHODS A lyophilized hemolyzate prepared from human erythrocytes containing a physiological HbA1c level (5.5%) was sent to 3,500 French laboratories in February of 1995 and assayed as a patient's sample under routine conditions. Distribution of values was analyzed from the reported results for each method. The results were compared with the assigned value (acceptable range: ± 20%) and with the upper value of the reference range currently used.

RESULTS Results were obtained from 2,674 laboratories, among which 39% used cationexchange chromatography methods, 37.5% affinity chromatography, 16% immunological methods, and 7.5% electrophoresis. The number of laboratories using immunological methods increased from 100 to 400 between 1993 and 1995. The overall interlaboratory coefficient of variation (CV) was 20.2%, with within-method CVs ranging between 3.2 and 29.5%. Method-to-method accuracy varied dramatically, with mean HbA1c values ranging from 4.4 to 8.2%. Results from 75% of the laboratories were comprised in the acceptable range; 88% of them reported a value within the normal range of the method used.

CONCLUSIONS The interlaboratory variability of results illustrates the difficulties encountered by diabetologists in the follow-up of diabetic patients using results obtained from different laboratories. It demonstrates the usefulness of the internationally developed standardization process of GHb measurements and points out the need for laboratories to fulfill good practices.

  • Received May 30, 1997.
  • Revision received October 13, 1997.
  • Accepted October 13, 1997.
  • Copyright © 1998 by the American Diabetes Association

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February 1998, 21(2)
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Evaluation of GHb Assays in France by National Quality Control Surveys
Philippe Gillery, Gilles Dumont, Anne Vassault
Diabetes Care Feb 1998, 21 (2) 265-270; DOI: 10.2337/diacare.21.2.265

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Evaluation of GHb Assays in France by National Quality Control Surveys
Philippe Gillery, Gilles Dumont, Anne Vassault
Diabetes Care Feb 1998, 21 (2) 265-270; DOI: 10.2337/diacare.21.2.265
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