Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays

Objective. To estimate performance characteristics and diagnostic value of immunofluorescent islet cell antibody (ICA) assay, immunoradiometric glutamic acid decarboxylase antibody (GADA) assay, and ELISA tyrosine phosphatase IA-2 antibody (IA-2A) and insulin antibody (IA) assays.Research Design and...

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Main Authors: Alexei V. Timofeev, Ksenia A. Gorst, Valentin Y. Uvarov, Ekaterina A. Pronina, Alisa V. Vitebskaya, Anastasiya V. Popovich, Anatoliy N. Tiulpakov, Natalia A. Zubkova, Olesya A. Gioeva, Yulia V. Tikhonovich, Alexander V. Ilin, Oleg Y. Latyshev, Goar F. Okminjan, Ksenia L. Kabolova, Julianna A. Kanokova, Leokadia Y. Zhuleva, Igor E. Koltunov, Elena E. Petriaikina, Irina G. Rybkina, Irina V. Garyaeva, Salome L. Guguchia, Angelina B. Shimarova, Artiom V. Bullikh, Irina G. Kolomina, Evgenia A. Evsyukova, Sergei S. Bukin, Natalia N. Egarmina, Natalia Y. Arbatskaya, Elina Y. Yanovskaya, Vladimir I. Popenko, Alexander A. Arkhipkin
Format: Article
Language:English
Published: Endocrinology Research Centre 2016-11-01
Series:Сахарный диабет
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Online Access:https://www.dia-endojournals.ru/jour/article/view/8032
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author Alexei V. Timofeev
Ksenia A. Gorst
Valentin Y. Uvarov
Ekaterina A. Pronina
Alisa V. Vitebskaya
Anastasiya V. Popovich
Anatoliy N. Tiulpakov
Natalia A. Zubkova
Olesya A. Gioeva
Yulia V. Tikhonovich
Alexander V. Ilin
Oleg Y. Latyshev
Goar F. Okminjan
Ksenia L. Kabolova
Julianna A. Kanokova
Leokadia Y. Zhuleva
Igor E. Koltunov
Elena E. Petriaikina
Irina G. Rybkina
Irina V. Garyaeva
Salome L. Guguchia
Angelina B. Shimarova
Artiom V. Bullikh
Irina G. Kolomina
Evgenia A. Evsyukova
Sergei S. Bukin
Natalia N. Egarmina
Natalia Y. Arbatskaya
Elina Y. Yanovskaya
Vladimir I. Popenko
Alexander A. Arkhipkin
author_facet Alexei V. Timofeev
Ksenia A. Gorst
Valentin Y. Uvarov
Ekaterina A. Pronina
Alisa V. Vitebskaya
Anastasiya V. Popovich
Anatoliy N. Tiulpakov
Natalia A. Zubkova
Olesya A. Gioeva
Yulia V. Tikhonovich
Alexander V. Ilin
Oleg Y. Latyshev
Goar F. Okminjan
Ksenia L. Kabolova
Julianna A. Kanokova
Leokadia Y. Zhuleva
Igor E. Koltunov
Elena E. Petriaikina
Irina G. Rybkina
Irina V. Garyaeva
Salome L. Guguchia
Angelina B. Shimarova
Artiom V. Bullikh
Irina G. Kolomina
Evgenia A. Evsyukova
Sergei S. Bukin
Natalia N. Egarmina
Natalia Y. Arbatskaya
Elina Y. Yanovskaya
Vladimir I. Popenko
Alexander A. Arkhipkin
author_sort Alexei V. Timofeev
collection DOAJ
description Objective. To estimate performance characteristics and diagnostic value of immunofluorescent islet cell antibody (ICA) assay, immunoradiometric glutamic acid decarboxylase antibody (GADA) assay, and ELISA tyrosine phosphatase IA-2 antibody (IA-2A) and insulin antibody (IA) assays.Research Design and Methods. Antibodies were tested in 438 children and adolescents with newly diagnosed diabetes mellitus (DM) type 1, and in 891 subjects without DM type 1. ICA were determined by the classic indirect immunofluorescent method recommended by the Juvenile Diabetes Foundation International, GADA were determined with the Immunotech IRMA Anti-GAD kit, and IA-2A and IA were determined with Medizym Anti-IA2 and Orgentec Anti-Insulin ELISA kits, respectively. Sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of the tests were estimated with contingency tables. Diagnostic accuracy was estimated from areas under receiver operating curves (AUC).Results. ICA test was of the greatest diagnostic value (Se=88%, Sp=96%, PPV=96%, NPV=94%, AUC=0,94), followed by IA-2A (Se=66%, Sp=98%, PPV=98%, NPV=59%, AUC=0,82) and GADA (Se=73%, Sp=84%, PPV=75%, NPV=83%, AUC=0,79). IA test exhibited a very low Se (4,3%) and lacked diagnostic accuracy (AUC=0,5).Conclusions. We recommend to use ICA, IA-2A and GADA tests surveyed in our study for diagnosis of DM type 1 and differential diagnosis of DM. We don’t recommend IA testing with an Orgentec Anti-Insulin ELISA kit for usage in clinical practice.
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spelling doaj-art-9b477f127dc84b3cbb0b91b1699fd6582025-08-20T03:09:03ZengEndocrinology Research CentreСахарный диабет2072-03512072-03782016-11-0119433134010.14341/DM80327512Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assaysAlexei V. Timofeev0Ksenia A. Gorst1Valentin Y. Uvarov2Ekaterina A. Pronina3Alisa V. Vitebskaya4Anastasiya V. Popovich5Anatoliy N. Tiulpakov6Natalia A. Zubkova7Olesya A. Gioeva8Yulia V. Tikhonovich9Alexander V. Ilin10Oleg Y. Latyshev11Goar F. Okminjan12Ksenia L. Kabolova13Julianna A. Kanokova14Leokadia Y. Zhuleva15Igor E. Koltunov16Elena E. Petriaikina17Irina G. Rybkina18Irina V. Garyaeva19Salome L. Guguchia20Angelina B. Shimarova21Artiom V. Bullikh22Irina G. Kolomina23Evgenia A. Evsyukova24Sergei S. Bukin25Natalia N. Egarmina26Natalia Y. Arbatskaya27Elina Y. Yanovskaya28Vladimir I. Popenko29Alexander A. Arkhipkin30I.M.Sechenov First Moscow State Medical UniversityI.M.Sechenov First Moscow State Medical UniversityI.M.Sechenov First Moscow State Medical UniversityI.M.Sechenov First Moscow State Medical UniversityI.M.Sechenov First Moscow State Medical UniversityI.M.Sechenov First Moscow State Medical UniversityEndocrinology Research CentreEndocrinology Research CentreEndocrinology Research CentreEndocrinology Research CentreEndocrinology Research CentreRussian Medical Academy of Postgraduate EducationRussian Medical Academy of Postgraduate EducationRussian Medical Academy of Postgraduate EducationRussian Medical Academy of Postgraduate EducationRussian Medical Academy of Postgraduate EducationMorozov Children Clinical HospitalMorozov Children Clinical HospitalMorozov Children Clinical HospitalMorozov Children Clinical HospitalMorozov Children Clinical HospitalMorozov Children Clinical HospitalMorozov Children Clinical HospitalBashliaeva Children Clinical HospitalBashliaeva Children Clinical HospitalBashliaeva Children Clinical HospitalBashliaeva Children Clinical HospitalPirogov Russian National Research Medical UniversityPirogov Russian National Research Medical UniversityEngelhardt Institute of Molecular Biology Russian Academy of SciencesScientific Center EFIS Ltd.Objective. To estimate performance characteristics and diagnostic value of immunofluorescent islet cell antibody (ICA) assay, immunoradiometric glutamic acid decarboxylase antibody (GADA) assay, and ELISA tyrosine phosphatase IA-2 antibody (IA-2A) and insulin antibody (IA) assays.Research Design and Methods. Antibodies were tested in 438 children and adolescents with newly diagnosed diabetes mellitus (DM) type 1, and in 891 subjects without DM type 1. ICA were determined by the classic indirect immunofluorescent method recommended by the Juvenile Diabetes Foundation International, GADA were determined with the Immunotech IRMA Anti-GAD kit, and IA-2A and IA were determined with Medizym Anti-IA2 and Orgentec Anti-Insulin ELISA kits, respectively. Sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of the tests were estimated with contingency tables. Diagnostic accuracy was estimated from areas under receiver operating curves (AUC).Results. ICA test was of the greatest diagnostic value (Se=88%, Sp=96%, PPV=96%, NPV=94%, AUC=0,94), followed by IA-2A (Se=66%, Sp=98%, PPV=98%, NPV=59%, AUC=0,82) and GADA (Se=73%, Sp=84%, PPV=75%, NPV=83%, AUC=0,79). IA test exhibited a very low Se (4,3%) and lacked diagnostic accuracy (AUC=0,5).Conclusions. We recommend to use ICA, IA-2A and GADA tests surveyed in our study for diagnosis of DM type 1 and differential diagnosis of DM. We don’t recommend IA testing with an Orgentec Anti-Insulin ELISA kit for usage in clinical practice.https://www.dia-endojournals.ru/jour/article/view/8032diabetes mellitusdiabetes mellitus type 1differential diagnosisautoantibodiesislet cell antibodyglutamic acid decarboxylase antibodytyrosine phosphatase antibodyinsulin antibodyimmunofluorescence assayradioimmune assayimmunoenzyme assa
spellingShingle Alexei V. Timofeev
Ksenia A. Gorst
Valentin Y. Uvarov
Ekaterina A. Pronina
Alisa V. Vitebskaya
Anastasiya V. Popovich
Anatoliy N. Tiulpakov
Natalia A. Zubkova
Olesya A. Gioeva
Yulia V. Tikhonovich
Alexander V. Ilin
Oleg Y. Latyshev
Goar F. Okminjan
Ksenia L. Kabolova
Julianna A. Kanokova
Leokadia Y. Zhuleva
Igor E. Koltunov
Elena E. Petriaikina
Irina G. Rybkina
Irina V. Garyaeva
Salome L. Guguchia
Angelina B. Shimarova
Artiom V. Bullikh
Irina G. Kolomina
Evgenia A. Evsyukova
Sergei S. Bukin
Natalia N. Egarmina
Natalia Y. Arbatskaya
Elina Y. Yanovskaya
Vladimir I. Popenko
Alexander A. Arkhipkin
Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays
Сахарный диабет
diabetes mellitus
diabetes mellitus type 1
differential diagnosis
autoantibodies
islet cell antibody
glutamic acid decarboxylase antibody
tyrosine phosphatase antibody
insulin antibody
immunofluorescence assay
radioimmune assay
immunoenzyme assa
title Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays
title_full Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays
title_fullStr Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays
title_full_unstemmed Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays
title_short Diagnostic value of islet autoantibody assays practised in Russia. 1. Classic immunofluorescence islet cell antibody assay, immunoradiometric glutamic acid decarboxylase antibody assay, and ELISA tyrosine phosphatase antibody and insulin antibody assays
title_sort diagnostic value of islet autoantibody assays practised in russia 1 classic immunofluorescence islet cell antibody assay immunoradiometric glutamic acid decarboxylase antibody assay and elisa tyrosine phosphatase antibody and insulin antibody assays
topic diabetes mellitus
diabetes mellitus type 1
differential diagnosis
autoantibodies
islet cell antibody
glutamic acid decarboxylase antibody
tyrosine phosphatase antibody
insulin antibody
immunofluorescence assay
radioimmune assay
immunoenzyme assa
url https://www.dia-endojournals.ru/jour/article/view/8032
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