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Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes: TEDDY
Author(s) -
Vehik Kendra,
Fiske Steven W.,
Logan Chad A.,
Agardh Daniel,
Cilio Corrado M.,
Hagopian William,
Simell Olli,
Roivainen Merja,
She JinXiong,
Briese Thomas,
Oikarinen Sami,
Hyoty Heikki,
Ziegler AnetteG.,
Rewers Marian,
Lernmark Ake,
Akolkar Beena,
Krischer Jeffrey P.,
Burkhardt Brant R.
Publication year - 2013
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.2427
Subject(s) - concordance , medicine , type 1 diabetes , environmental health , autoantibody , immunology , diabetes mellitus , antibody , endocrinology
Abstract Background The vast array and quantity of longitudinal samples collected in The Environmental Determinants of Diabetes in the Young study present a series of challenges in terms of quality control procedures and data validity. To address this, pilot studies have been conducted to standardize and enhance both biospecimen collection and sample obtainment in terms of autoantibody collection, stool sample preservation, RNA, biomarker stability, metabolic biomarkers and T‐cell viability. Research Design and Methods The Environmental Determinants of Diabetes in the Young is a multicentre, international prospective study ( n  = 8677) designed to identify environmental triggers of type 1 diabetes (T1D) in genetically at‐risk children from ages 3 months until 15 years. The study is conducted through six primary clinical centres located in four countries. Results As of May 2012, over three million biological samples and 250 million total data points have been collected, which will be analysed to assess autoimmunity status, presence of inflammatory biomarkers, genetic factors, exposure to infectious agents, dietary biomarkers and other potentially important environmental exposures in relation to autoimmunity and progression to T1D. Conclusions Detailed procedures were utilized to standardize both data harmonization and management when handling a large quantity of longitudinal samples obtained from multiple locations. In addition, a description of the available specimens is provided that serve as an invaluable repository for the elucidation of determinants in T1D focusing on autoantibody concordance and harmonization, transglutaminase autoantibody, inflammatory biomarkers (T‐cells), genetic proficiency testing, RNA lab internal quality control testing, infectious agents (monitoring cross‐contamination, virus preservation and nasal swab collection validity) and HbA 1c testing. Copyright © 2013 John Wiley & Sons, Ltd.

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