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

Bonifacio, E. ; Boitard, C. ; Gleichmann, H. ; Shattock, M. A. ; Molenaar, J. L. ; Bottazzo, G. F. ; Assa, S. ; Arnaiz-Villena, A. ; Barbosa, J. and Betterle, C. , et al. (1990) In Diabetologia 33(12). p.731-736
Abstract

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... (More)

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.

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Contribution to journal
publication status
published
subject
keywords
Islet cell antibody, Juvenile Diabetes Foundation units, quality control, standards, Type 1 (insulin-dependent) diabetes
in
Diabetologia
volume
33
issue
12
pages
731 - 736
publisher
Springer
external identifiers
  • pmid:2073986
  • scopus:0025674635
ISSN
0012-186X
DOI
10.1007/BF00400345
language
English
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no
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78a33afa-4cf5-4e92-8b99-a1b8b436eab6
date added to LUP
2019-09-11 09:42:02
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2020-01-13 02:21:13
@article{78a33afa-4cf5-4e92-8b99-a1b8b436eab6,
  abstract     = {<p>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 &lt;50% in three assays. Low specificity was strongly associated with poor precision. The detection limit of assays ranged from &lt;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.</p>},
  author       = {Bonifacio, E. and Boitard, C. and Gleichmann, H. and Shattock, M. A. and Molenaar, J. L. and Bottazzo, G. F. and Assa, S. and Arnaiz-Villena, A. and Barbosa, J. and Betterle, C. and Beutner, E. and Bright, G. and Chapel, H. and Codina, M. and Dawkins, R. and Deitsch, E. and Di Mario, U. and Eisenbarth, G. and Elliot, R. and Gomis de Barbara, R. and Hanafusa, T. and Harrison, L. and Helmke, K. and Howard, C. and Veld, P. In t. and Kawathara, D. and Kobayashi, T. and Landin, M. and Lernmark, Å and Maclaren, N. and Mandrup-Poulsen, T. and Manna, R. and Miettinen, A. and Palmer, J. and Panczel, P. and Peter, J. and Pirich, K. and Quenette, L. and Reeves, G. and Reinauer, K. and Scherbaum, W. and Scott-Morgan, L. and Vergani, D. and Vialettes, B.},
  issn         = {0012-186X},
  language     = {eng},
  month        = {12},
  number       = {12},
  pages        = {731--736},
  publisher    = {Springer},
  series       = {Diabetologia},
  title        = {Assessment of precision, concordance, specificity, and sensitivity of islet cell antibody measurement in 41 assays},
  url          = {http://dx.doi.org/10.1007/BF00400345},
  doi          = {10.1007/BF00400345},
  volume       = {33},
  year         = {1990},
}