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Diabetes Antibody Standardization Program: first assay proficiency evaluation.

Polly J Bingley1, Ezio Bonifacio, Patricia W Mueller

  • 1Division of Medicine, Medical School Unit, University of Bristol, Southmead Hospital, Bristol BS10 5NB, U.K. polly.bingley@bristol.ac.uk

Diabetes
|April 30, 2003
PubMed
Summary
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The first Diabetes Antibody Standardization Program proficiency test revealed variable performance in autoantibody assays for type 1 diabetes. Standardization of assay protocols is crucial for consistent results in GAD and IA-2 autoantibody testing.

Area of Science:

  • Immunology
  • Endocrinology
  • Clinical Chemistry

Background:

  • Type 1 diabetes diagnosis relies on detecting autoantibodies like GAD65, IA-2, and insulin.
  • Standardization of these autoantibody assays is essential for accurate diagnosis and monitoring.
  • The Diabetes Antibody Standardization Program (DASP) was established to evaluate assay performance.

Purpose of the Study:

  • To assess the implementation of autoantibody assay methods across laboratories.
  • To evaluate the performance of a new World Health Organization (WHO) reference reagent for GAD and IA-2 autoantibodies.
  • To determine the concordance and sensitivity of various assays for type 1 diabetes autoantibodies.

Main Methods:

  • Forty-six international laboratories participated in the first DASP proficiency evaluation.

Related Experiment Videos

  • Coded sera from type 1 diabetes patients and controls were analyzed using GAD autoantibody (GADA), IA-2 autoantibody (IA-2A), and insulin autoantibody (IAA) assays.
  • Results were analyzed using receiver operator characteristic (ROC) curves, with sensitivity adjusted to 90% specificity.

    • Main Results:

    • Median adjusted sensitivities were 84% for GADA, 58% for IA-2A, and 36% for IAA.
    • ROC analysis confirmed significant differences between patients and controls for GADA and IA-2A assays.
    • Good laboratory concordance was observed for GADA and IA-2A, but poor concordance for IAA.

    Conclusions:

    • Significant variability exists in the performance of type 1 diabetes autoantibody assays.
    • The WHO reference reagent showed good concordance for GADA and IA-2A, but IAA assay performance requires improvement.
    • Standardizing assay protocols is necessary to achieve consistent and high-quality autoantibody testing globally.