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Harmonization of Glutamic Acid Decarboxylase and Islet Antigen-2 Autoantibody Assays for National Institute of Diabetes and Digestive and Kidney Diseases Consortia

Background/Rationale: Autoantibodies to islet antigen-2 (IA-2A) and glutamic acid decarboxylase (GADA) are markers for diagnosis, screening, and measuring outcomes in National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) consortia studies. A harmonization program was established t... Full description

Journal Title: The Journal of Clinical Endocrinology & Metabolism 2010, Vol.95 (7), p.3360-3367
Main Author: Bonifacio, Ezio
Other Authors: Yu, Liping , Williams, Alastair K , Eisenbarth, George S , Bingley, Polly J , Marcovina, Santica M , Adler, Kerstin , Ziegler, Anette G , Mueller, Patricia W , Schatz, Desmond A , Krischer, Jeffrey P , Steffes, Michael W , Akolkar, Beena
Format: Electronic Article Electronic Article
Language: English
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Publisher: Bethesda, MD: Endocrine Society
ID: ISSN: 0021-972X
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2928900
title: Harmonization of Glutamic Acid Decarboxylase and Islet Antigen-2 Autoantibody Assays for National Institute of Diabetes and Digestive and Kidney Diseases Consortia
format: Article
creator:
  • Bonifacio, Ezio
  • Yu, Liping
  • Williams, Alastair K
  • Eisenbarth, George S
  • Bingley, Polly J
  • Marcovina, Santica M
  • Adler, Kerstin
  • Ziegler, Anette G
  • Mueller, Patricia W
  • Schatz, Desmond A
  • Krischer, Jeffrey P
  • Steffes, Michael W
  • Akolkar, Beena
subjects:
  • Abridged Index Medicus
  • Academies and Institutes
  • Adolescent
  • Adult
  • Autoantibodies - immunology
  • Biological and medical sciences
  • Diabetes. Impaired glucose tolerance
  • Endocrine pancreas. Apud cells (diseases)
  • Endocrinopathies
  • Etiopathogenesis. Screening. Investigations. Target tissue resistance
  • Feeding. Feeding behavior
  • Fundamental and applied biological sciences. Psychology
  • Glutamate Decarboxylase - immunology
  • Humans
  • Medical sciences
  • Original
  • Original Article
  • Radioligand Assay - methods
  • Receptor-Like Protein Tyrosine Phosphatases, Class 8 - immunology
  • Reference Values
  • Sensitivity and Specificity
  • Vertebrates: anatomy and physiology, studies on body, several organs or systems
  • Vertebrates: endocrinology
ispartof: The Journal of Clinical Endocrinology & Metabolism, 2010, Vol.95 (7), p.3360-3367
description: Background/Rationale: Autoantibodies to islet antigen-2 (IA-2A) and glutamic acid decarboxylase (GADA) are markers for diagnosis, screening, and measuring outcomes in National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) consortia studies. A harmonization program was established to increase comparability of results within and among these studies. Methods: Large volumes of six working calibrators were prepared from pooled sera with GADA 4.8–493 World Health Organization (WHO) units/ml and IA-2A 2–235 WHO units/ml. Harmonized assay protocols for IA-2A and GADA using 35S-methionine-labelled in vitro transcribed and translated antigens were developed based on methods in use in three NIDDK laboratories. Antibody thresholds were defined using sera from patients with recent onset type 1 diabetes and healthy controls. To evaluate the impact of the harmonized assay protocol on concordance of IA-2A and GADA results, two laboratories retested stored TEDDY study sera using the harmonized assays. Results: The harmonized assays gave comparable but not identical results in the three laboratories. For IA-2A, using a common threshold of 5 DK units/ml, 549 of 550 control and patient samples were concordantly scored as positive or negative, specificity was greater than 99% with sensitivity 64% in all laboratories. For GADA, using thresholds equivalent to the 97th percentile of 974 control samples in each laboratory, 1051 (97.9%) of 1074 samples were concordant. On the retested TEDDY samples, discordance decreased from 4 to 1.8% for IA-2A (n = 604 samples; P = 0.02) and from 15.4 to 2.7% for GADA (n = 515 samples; P < 0.0001). Conclusion: Harmonization of GADA and IA-2A is feasible using large volume working calibrators and common protocols and is an effective approach to ensure consistency in autoantibody measurements. Improved concordance of measurement of islet autoantibodies among international laboratories is achieved by the establishment of harmonized, sensitive, and specific reference immunoassays.
language: eng
source:
identifier: ISSN: 0021-972X
fulltext: no_fulltext
issn:
  • 0021-972X
  • 1945-7197
url: Link


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titleHarmonization of Glutamic Acid Decarboxylase and Islet Antigen-2 Autoantibody Assays for National Institute of Diabetes and Digestive and Kidney Diseases Consortia
creatorBonifacio, Ezio ; Yu, Liping ; Williams, Alastair K ; Eisenbarth, George S ; Bingley, Polly J ; Marcovina, Santica M ; Adler, Kerstin ; Ziegler, Anette G ; Mueller, Patricia W ; Schatz, Desmond A ; Krischer, Jeffrey P ; Steffes, Michael W ; Akolkar, Beena
creatorcontribBonifacio, Ezio ; Yu, Liping ; Williams, Alastair K ; Eisenbarth, George S ; Bingley, Polly J ; Marcovina, Santica M ; Adler, Kerstin ; Ziegler, Anette G ; Mueller, Patricia W ; Schatz, Desmond A ; Krischer, Jeffrey P ; Steffes, Michael W ; Akolkar, Beena
descriptionBackground/Rationale: Autoantibodies to islet antigen-2 (IA-2A) and glutamic acid decarboxylase (GADA) are markers for diagnosis, screening, and measuring outcomes in National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) consortia studies. A harmonization program was established to increase comparability of results within and among these studies. Methods: Large volumes of six working calibrators were prepared from pooled sera with GADA 4.8–493 World Health Organization (WHO) units/ml and IA-2A 2–235 WHO units/ml. Harmonized assay protocols for IA-2A and GADA using 35S-methionine-labelled in vitro transcribed and translated antigens were developed based on methods in use in three NIDDK laboratories. Antibody thresholds were defined using sera from patients with recent onset type 1 diabetes and healthy controls. To evaluate the impact of the harmonized assay protocol on concordance of IA-2A and GADA results, two laboratories retested stored TEDDY study sera using the harmonized assays. Results: The harmonized assays gave comparable but not identical results in the three laboratories. For IA-2A, using a common threshold of 5 DK units/ml, 549 of 550 control and patient samples were concordantly scored as positive or negative, specificity was greater than 99% with sensitivity 64% in all laboratories. For GADA, using thresholds equivalent to the 97th percentile of 974 control samples in each laboratory, 1051 (97.9%) of 1074 samples were concordant. On the retested TEDDY samples, discordance decreased from 4 to 1.8% for IA-2A (n = 604 samples; P = 0.02) and from 15.4 to 2.7% for GADA (n = 515 samples; P < 0.0001). Conclusion: Harmonization of GADA and IA-2A is feasible using large volume working calibrators and common protocols and is an effective approach to ensure consistency in autoantibody measurements. Improved concordance of measurement of islet autoantibodies among international laboratories is achieved by the establishment of harmonized, sensitive, and specific reference immunoassays.
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languageeng
publisherBethesda, MD: Endocrine Society
subjectAbridged Index Medicus ; Academies and Institutes ; Adolescent ; Adult ; Autoantibodies - immunology ; Biological and medical sciences ; Diabetes. Impaired glucose tolerance ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Feeding. Feeding behavior ; Fundamental and applied biological sciences. Psychology ; Glutamate Decarboxylase - immunology ; Humans ; Medical sciences ; Original ; Original Article ; Radioligand Assay - methods ; Receptor-Like Protein Tyrosine Phosphatases, Class 8 - immunology ; Reference Values ; Sensitivity and Specificity ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; Vertebrates: endocrinology
ispartofThe Journal of Clinical Endocrinology & Metabolism, 2010, Vol.95 (7), p.3360-3367
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0Bonifacio, Ezio
1Yu, Liping
2Williams, Alastair K
3Eisenbarth, George S
4Bingley, Polly J
5Marcovina, Santica M
6Adler, Kerstin
7Ziegler, Anette G
8Mueller, Patricia W
9Schatz, Desmond A
10Krischer, Jeffrey P
11Steffes, Michael W
12Akolkar, Beena
title
0Harmonization of Glutamic Acid Decarboxylase and Islet Antigen-2 Autoantibody Assays for National Institute of Diabetes and Digestive and Kidney Diseases Consortia
1The Journal of Clinical Endocrinology & Metabolism
addtitleJ Clin Endocrinol Metab
descriptionBackground/Rationale: Autoantibodies to islet antigen-2 (IA-2A) and glutamic acid decarboxylase (GADA) are markers for diagnosis, screening, and measuring outcomes in National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) consortia studies. A harmonization program was established to increase comparability of results within and among these studies. Methods: Large volumes of six working calibrators were prepared from pooled sera with GADA 4.8–493 World Health Organization (WHO) units/ml and IA-2A 2–235 WHO units/ml. Harmonized assay protocols for IA-2A and GADA using 35S-methionine-labelled in vitro transcribed and translated antigens were developed based on methods in use in three NIDDK laboratories. Antibody thresholds were defined using sera from patients with recent onset type 1 diabetes and healthy controls. To evaluate the impact of the harmonized assay protocol on concordance of IA-2A and GADA results, two laboratories retested stored TEDDY study sera using the harmonized assays. Results: The harmonized assays gave comparable but not identical results in the three laboratories. For IA-2A, using a common threshold of 5 DK units/ml, 549 of 550 control and patient samples were concordantly scored as positive or negative, specificity was greater than 99% with sensitivity 64% in all laboratories. For GADA, using thresholds equivalent to the 97th percentile of 974 control samples in each laboratory, 1051 (97.9%) of 1074 samples were concordant. On the retested TEDDY samples, discordance decreased from 4 to 1.8% for IA-2A (n = 604 samples; P = 0.02) and from 15.4 to 2.7% for GADA (n = 515 samples; P < 0.0001). Conclusion: Harmonization of GADA and IA-2A is feasible using large volume working calibrators and common protocols and is an effective approach to ensure consistency in autoantibody measurements. Improved concordance of measurement of islet autoantibodies among international laboratories is achieved by the establishment of harmonized, sensitive, and specific reference immunoassays.
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1Academies and Institutes
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3Adult
4Autoantibodies - immunology
5Biological and medical sciences
6Diabetes. Impaired glucose tolerance
7Endocrine pancreas. Apud cells (diseases)
8Endocrinopathies
9Etiopathogenesis. Screening. Investigations. Target tissue resistance
10Feeding. Feeding behavior
11Fundamental and applied biological sciences. Psychology
12Glutamate Decarboxylase - immunology
13Humans
14Medical sciences
15Original
16Original Article
17Radioligand Assay - methods
18Receptor-Like Protein Tyrosine Phosphatases, Class 8 - immunology
19Reference Values
20Sensitivity and Specificity
21Vertebrates: anatomy and physiology, studies on body, several organs or systems
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8Mueller, Patricia W
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10Krischer, Jeffrey P
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titleHarmonization of Glutamic Acid Decarboxylase and Islet Antigen-2 Autoantibody Assays for National Institute of Diabetes and Digestive and Kidney Diseases Consortia
authorBonifacio, Ezio ; Yu, Liping ; Williams, Alastair K ; Eisenbarth, George S ; Bingley, Polly J ; Marcovina, Santica M ; Adler, Kerstin ; Ziegler, Anette G ; Mueller, Patricia W ; Schatz, Desmond A ; Krischer, Jeffrey P ; Steffes, Michael W ; Akolkar, Beena
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1Academies and Institutes
2Adolescent
3Adult
4Autoantibodies - immunology
5Biological and medical sciences
6Diabetes. Impaired glucose tolerance
7Endocrine pancreas. Apud cells (diseases)
8Endocrinopathies
9Etiopathogenesis. Screening. Investigations. Target tissue resistance
10Feeding. Feeding behavior
11Fundamental and applied biological sciences. Psychology
12Glutamate Decarboxylase - immunology
13Humans
14Medical sciences
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16Original Article
17Radioligand Assay - methods
18Receptor-Like Protein Tyrosine Phosphatases, Class 8 - immunology
19Reference Values
20Sensitivity and Specificity
21Vertebrates: anatomy and physiology, studies on body, several organs or systems
22Vertebrates: endocrinology
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1Yu, Liping
2Williams, Alastair K
3Eisenbarth, George S
4Bingley, Polly J
5Marcovina, Santica M
6Adler, Kerstin
7Ziegler, Anette G
8Mueller, Patricia W
9Schatz, Desmond A
10Krischer, Jeffrey P
11Steffes, Michael W
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0Bonifacio, Ezio
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3Eisenbarth, George S
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7Ziegler, Anette G
8Mueller, Patricia W
9Schatz, Desmond A
10Krischer, Jeffrey P
11Steffes, Michael W
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jtitleThe Journal of Clinical Endocrinology & Metabolism
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notesAddress all correspondence and requests for reprints to: Ezio Bonifacio, Ph.D., Center for Regenerative Therapies-Dresden, Dresden University of Technology, Biotechnology Center, Tatzberg 47/49, 01307 Dresden, Germany. E-mail: ezio.bonifacio@crt-dresden.de.
abstractBackground/Rationale: Autoantibodies to islet antigen-2 (IA-2A) and glutamic acid decarboxylase (GADA) are markers for diagnosis, screening, and measuring outcomes in National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) consortia studies. A harmonization program was established to increase comparability of results within and among these studies. Methods: Large volumes of six working calibrators were prepared from pooled sera with GADA 4.8–493 World Health Organization (WHO) units/ml and IA-2A 2–235 WHO units/ml. Harmonized assay protocols for IA-2A and GADA using 35S-methionine-labelled in vitro transcribed and translated antigens were developed based on methods in use in three NIDDK laboratories. Antibody thresholds were defined using sera from patients with recent onset type 1 diabetes and healthy controls. To evaluate the impact of the harmonized assay protocol on concordance of IA-2A and GADA results, two laboratories retested stored TEDDY study sera using the harmonized assays. Results: The harmonized assays gave comparable but not identical results in the three laboratories. For IA-2A, using a common threshold of 5 DK units/ml, 549 of 550 control and patient samples were concordantly scored as positive or negative, specificity was greater than 99% with sensitivity 64% in all laboratories. For GADA, using thresholds equivalent to the 97th percentile of 974 control samples in each laboratory, 1051 (97.9%) of 1074 samples were concordant. On the retested TEDDY samples, discordance decreased from 4 to 1.8% for IA-2A (n = 604 samples; P = 0.02) and from 15.4 to 2.7% for GADA (n = 515 samples; P < 0.0001). Conclusion: Harmonization of GADA and IA-2A is feasible using large volume working calibrators and common protocols and is an effective approach to ensure consistency in autoantibody measurements. Improved concordance of measurement of islet autoantibodies among international laboratories is achieved by the establishment of harmonized, sensitive, and specific reference immunoassays.
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pubEndocrine Society
pmid20444913
doi10.1210/jc.2010-0293
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