Islet Autoantibody standardization program 2018 Workshop: Interlaboratory comparison of glutamic acid decarboxylase autoantibody assay performance

Vito Lampasona, David L. Pittman, Alistair J. Williams, Peter Achenbach, Michael Schlosser, Beena Akolkar, William E. Winter

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The Islet Autoantibody Standardization Program (IASP) aims to improve the performance of immunoassays measuring type 1 diabetes (T1D)-associated autoantibodies and the concordance of results among laboratories. IASP organizes international interlaboratory assay comparison studies in which blinded serum samples are distributed to participating laboratories, followed by centralized collection and analysis of results, providing participants with an unbiased comparative assessment. In this report, we describe the results of glutamic acid decarboxylase autoantibody (GADA) assays presented in the IASP 2018 workshop. METHODS: In May 2018, IASP distributed to participants uniquely coded sera from 43 new-onset T1D patients, 7 multiple autoantibody-positive nondiabetic individuals, and 90 blood donors. Results were analyzed for the following metrics: sensitivity, specificity, accuracy, area under the ROC curve (ROC-AUC), partial ROC-AUC at 95% specificity (pAUC95), and concordance of qualitative and quantitative results. RESULTS: Thirty-seven laboratories submitted results from a total of 48 different GADA assays adopting 9 different formats. The median ROC-AUC and pAUC95 of all assays were 0.87 [interquartile range (IQR), 0.83–0.89] and 0.036 (IQR, 0.032– 0.039), respectively. Large differences in pAUC95 (range, 0.001– 0.0411) were observed across assays. Of formats widely adopted, bridge ELISAs showed the best median pAUC95 (0.039; range, 0.036 – 0.041). CONCLUSIONS: Several novel assay formats submitted to this study showed heterogeneous performance. In 2018, the majority of the best performing GADA immunoassays consisted of novel or established nonradioactive tests that proved on a par or superior to the radiobinding assay, the previous gold standard assay format for GADA measurement.

Original languageEnglish
Pages (from-to)1141-1152
Number of pages12
JournalClinical Chemistry
Volume65
Issue number9
DOIs
Publication statusPublished - Jan 1 2019

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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