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Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes: TEDDY

Vehik, Kendra; Fiske, Steven W.; Logan, Chad A.; Agardh, Daniel LU ; Cilio, Corrado LU ; Hagopian, William; Simell, Olli; Roivainen, Merja; She, Jin-Xiong and Briese, Thomas, et al. (2013) In Diabetes/Metabolism Research Reviews 29(7). p.557-567
Abstract
BackgroundThe 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 MethodsThe 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 3months... (More)
BackgroundThe 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 MethodsThe 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 3months until 15years. The study is conducted through six primary clinical centres located in four countries. ResultsAs 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. ConclusionsDetailed 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 (c) 2013 John Wiley & Sons, Ltd. (Less)
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keywords
quality control, data integrity, stool sample preservation, RNA, biomarker stability, metabolic biomarkers, T-cell viability
in
Diabetes/Metabolism Research Reviews
volume
29
issue
7
pages
557 - 567
publisher
John Wiley & Sons
external identifiers
  • wos:000325035600006
  • scopus:84884958537
ISSN
1520-7552
DOI
10.1002/dmrr.2427
language
English
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yes
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6a6d9515-c2d8-4fd4-b239-ecbf2db2c2fc (old id 4171975)
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2013-12-06 12:30:49
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2019-03-12 01:17:20
@article{6a6d9515-c2d8-4fd4-b239-ecbf2db2c2fc,
  abstract     = {BackgroundThe 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 MethodsThe 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 3months until 15years. The study is conducted through six primary clinical centres located in four countries. ResultsAs 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. ConclusionsDetailed 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 (c) 2013 John Wiley & Sons, Ltd.},
  author       = {Vehik, Kendra and Fiske, Steven W. and Logan, Chad A. and Agardh, Daniel and Cilio, Corrado and Hagopian, William and Simell, Olli and Roivainen, Merja and She, Jin-Xiong and Briese, Thomas and Oikarinen, Sami and Hyoty, Heikki and Ziegler, Anette-G. and Rewers, Marian and Lernmark, Åke and Akolkar, Beena and Krischer, Jeffrey P. and Burkhardt, Brant R.},
  issn         = {1520-7552},
  keyword      = {quality control,data integrity,stool sample preservation,RNA,biomarker stability,metabolic biomarkers,T-cell viability},
  language     = {eng},
  number       = {7},
  pages        = {557--567},
  publisher    = {John Wiley & Sons},
  series       = {Diabetes/Metabolism Research Reviews},
  title        = {Methods, quality control and specimen management in an international multicentre investigation of type 1 diabetes: TEDDY},
  url          = {http://dx.doi.org/10.1002/dmrr.2427},
  volume       = {29},
  year         = {2013},
}