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Åke Lernmark

Principal investigator

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Assessment of precision, concordance, specificity, and sensitivity of islet cell antibody measurement in 41 assays

Author

  • E. Bonifacio
  • C. Boitard
  • H. Gleichmann
  • M. A. Shattock
  • J. L. Molenaar
  • G. F. Bottazzo
  • S. Assa
  • A. Arnaiz-Villena
  • J. Barbosa
  • C. Betterle
  • E. Beutner
  • G. Bright
  • H. Chapel
  • M. Codina
  • R. Dawkins
  • E. Deitsch
  • U. Di Mario
  • G. Eisenbarth
  • R. Elliot
  • R. Gomis de Barbara
  • T. Hanafusa
  • L. Harrison
  • K. Helmke
  • C. Howard
  • P. In t. Veld
  • D. Kawathara
  • T. Kobayashi
  • M. Landin
  • Å Lernmark
  • N. Maclaren
  • T. Mandrup-Poulsen
  • R. Manna
  • A. Miettinen
  • J. Palmer
  • P. Panczel
  • J. Peter
  • K. Pirich
  • L. Quenette
  • G. Reeves
  • K. Reinauer
  • W. Scherbaum
  • L. Scott-Morgan
  • D. Vergani
  • B. Vialettes

Summary, in English

Forty-one assays were analysed at the 3rd International Workshop on the standardisation of islet cell antibodies. Analysis of precision demonstrated assays consistently detecting blind duplicates within one doubling dilution and capable of discriminating one doubling dilution differences in islet cell antibody concentration. Some assays, however, reported duplicates discrepantly by more than seven doubling dilutions, and consequently could not distinguish even large quantities of islet cell antibodies. Precision was best in assays from laboratories which had participated in all three Standardisation Workshops and was not dependent upon methodology. The use of the Juvenile, Diabetes Foundation reference islet cell antibody standard and standard curves reduced the scatter of results, and was best amongst assays with better precision. Twenty-seven assays reported all ten blood donor sera as negative. However, 14 assays did not, and specificity (negativity in health) was <50% in three assays. Low specificity was strongly associated with poor precision. The detection limit of assays ranged from <5 to 50 JDF units and was partially dependent upon methodology. Assays incorporating extended incubation had the lowest detection limits without a decrease in the specificity of the ten blood donor sera. Precise quantification is fundamental for the standardisation and comparability of islet cell antibodies. Precise quantitative assays have been identified and reference standards and common units established.

Publishing year

1990-12-01

Language

English

Pages

731-736

Publication/Series

Diabetologia

Volume

33

Issue

12

Document type

Journal article

Publisher

Springer

Topic

  • Endocrinology and Diabetes

Keywords

  • Islet cell antibody
  • Juvenile Diabetes Foundation units
  • quality control
  • standards
  • Type 1 (insulin-dependent) diabetes

Status

Published

ISBN/ISSN/Other

  • ISSN: 0012-186X