Islet Autoantibody Standardization Program 2018 Workshop : Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance

Show full item record



Permalink

http://hdl.handle.net/10138/319800

Citation

Participating Labs 2019 , ' Islet Autoantibody Standardization Program 2018 Workshop : Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance ' , Clinical Chemistry (Washington, DC) , vol. 65 , no. 9 , pp. 1141-1152 . https://doi.org/10.1373/clinchem.2019.304196

Title: Islet Autoantibody Standardization Program 2018 Workshop : Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance
Author: Participating Labs
Contributor organization: HUS Children and Adolescents
Children's Hospital
Mikael Knip / Principal Investigator
Lastentautien yksikkö
Helsinki University Hospital Area
Clinicum
Date: 2019-09
Language: eng
Number of pages: 12
Belongs to series: Clinical Chemistry (Washington, DC)
ISSN: 0009-9147
DOI: https://doi.org/10.1373/clinchem.2019.304196
URI: http://hdl.handle.net/10138/319800
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. (C) 2019 American Association for Clinical Chemistry
Subject: GAD AUTOANTIBODY
CELL ANTIBODIES
CONCORDANCE
AGREEMENT
INSULIN
SPECIFICITY
3111 Biomedicine
Peer reviewed: Yes
Rights: unspecified
Usage restriction: openAccess
Self-archived version: publishedVersion


Files in this item

Total number of downloads: Loading...

Files Size Format View
Islet_Autoantibody_Standardization.pdf 2.731Mb PDF View/Open

This item appears in the following Collection(s)

Show full item record