Tal Oron, Felipe de Jesus Cortez, Biana Shtaif, Peter V Robinson, Michal Yackobovitch-Gavan, Devangkumar Tandel, David Seftel, Moshe Phillip, Cheng-Ting Tsai, Galia Gat-Yablonski
{"title":"抗体检测凝集- pcr （ADAP）技术检测全血中胰岛自身抗体灵敏，适用于一般人群筛查。","authors":"Tal Oron, Felipe de Jesus Cortez, Biana Shtaif, Peter V Robinson, Michal Yackobovitch-Gavan, Devangkumar Tandel, David Seftel, Moshe Phillip, Cheng-Ting Tsai, Galia Gat-Yablonski","doi":"10.1155/2024/4238394","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Detection of type 1 diabetes (T1D) at the preclinical stage is possible by detecting islet autoantibodies (IAs) years before the appearance of symptomatic diabetes. The Antibody Detection Israeli Research is a general population screening program searching for children with multiple IAs who are at risk of developing T1D. IAs are measured in capillary or venous whole blood (WB) samples using the novel ultrasensitive antibody detection by agglutination-PCR (ADAP) technology.</p><p><strong>Objective: </strong>To assess the accuracy and reliability of the ADAP assay in venous and capillary WB.</p><p><strong>Materials and methods: </strong>In total, 50 children with T1D and 50 healthy controls participated in the study. Venous and capillary blood samples were drawn from participants with T1D, while only venous blood was drawn from the controls. The ADAP assay in venous and capillary blood was compared to the currently used assays in their ability to detect glutamic acid decarboxylase (GADA), islet antigen-2 (IA-2A), and insulin autoantibodies (IAAs).</p><p><strong>Results: </strong>The area under the curve using the receiver operating characteristic curves was comparable between the ADAP assay in WB and standard enzyme-linked immunosorbent assay (ELISA)/radioimmunoassay (RIA) for all three IAs GADA 0.946 (95% CI: 0.900-0.991) vs. 0.949 (0.906-0.992), <i>P</i>=0.873; IA-2A 0.747 (0.649-0.844) vs. 0.666 (0.587-0.744), <i>P</i>=0.106; IAA 1.000 (1.000-1.000) vs. 1.000 (1.000-1.000), <i>P</i>=1.000. The correlation between the levels of IA in venous and capillary WB using ADAP was <i>R</i> <sup>2</sup> = 0.958 (<i>P</i> < 0.01), <i>R</i> <sup>2</sup> = 0.943 (<i>P</i> < 0.01), and <i>R</i> <sup>2</sup> = 0.711 (<i>P</i> < 0.01) for GADA, IA-2A, and IAA, respectively. IA levels in venous and capillary WB using ADAP were comparable without a proportional bias in Bland-Altman's plots of agreement, suggesting the two methods may be used interchangeably.</p><p><strong>Conclusions: </strong>The ADAP assay is reliable in detecting IA in venous and capillary WB samples with comparable performance to standard RIA and ELISA. These findings open avenues for widespread use of the ADAP assay in future general population screening programs to detect children at risk of developing T1D.</p>","PeriodicalId":19797,"journal":{"name":"Pediatric Diabetes","volume":"2024 ","pages":"4238394"},"PeriodicalIF":3.9000,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12016989/pdf/","citationCount":"0","resultStr":"{\"title\":\"Detection of Islet Autoantibodies in Whole Blood by Antibody Detection by Agglutination-PCR (ADAP) Technology Is Sensitive and Suitable for General Population Screening Programs.\",\"authors\":\"Tal Oron, Felipe de Jesus Cortez, Biana Shtaif, Peter V Robinson, Michal Yackobovitch-Gavan, Devangkumar Tandel, David Seftel, Moshe Phillip, Cheng-Ting Tsai, Galia Gat-Yablonski\",\"doi\":\"10.1155/2024/4238394\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Detection of type 1 diabetes (T1D) at the preclinical stage is possible by detecting islet autoantibodies (IAs) years before the appearance of symptomatic diabetes. The Antibody Detection Israeli Research is a general population screening program searching for children with multiple IAs who are at risk of developing T1D. IAs are measured in capillary or venous whole blood (WB) samples using the novel ultrasensitive antibody detection by agglutination-PCR (ADAP) technology.</p><p><strong>Objective: </strong>To assess the accuracy and reliability of the ADAP assay in venous and capillary WB.</p><p><strong>Materials and methods: </strong>In total, 50 children with T1D and 50 healthy controls participated in the study. Venous and capillary blood samples were drawn from participants with T1D, while only venous blood was drawn from the controls. The ADAP assay in venous and capillary blood was compared to the currently used assays in their ability to detect glutamic acid decarboxylase (GADA), islet antigen-2 (IA-2A), and insulin autoantibodies (IAAs).</p><p><strong>Results: </strong>The area under the curve using the receiver operating characteristic curves was comparable between the ADAP assay in WB and standard enzyme-linked immunosorbent assay (ELISA)/radioimmunoassay (RIA) for all three IAs GADA 0.946 (95% CI: 0.900-0.991) vs. 0.949 (0.906-0.992), <i>P</i>=0.873; IA-2A 0.747 (0.649-0.844) vs. 0.666 (0.587-0.744), <i>P</i>=0.106; IAA 1.000 (1.000-1.000) vs. 1.000 (1.000-1.000), <i>P</i>=1.000. The correlation between the levels of IA in venous and capillary WB using ADAP was <i>R</i> <sup>2</sup> = 0.958 (<i>P</i> < 0.01), <i>R</i> <sup>2</sup> = 0.943 (<i>P</i> < 0.01), and <i>R</i> <sup>2</sup> = 0.711 (<i>P</i> < 0.01) for GADA, IA-2A, and IAA, respectively. IA levels in venous and capillary WB using ADAP were comparable without a proportional bias in Bland-Altman's plots of agreement, suggesting the two methods may be used interchangeably.</p><p><strong>Conclusions: </strong>The ADAP assay is reliable in detecting IA in venous and capillary WB samples with comparable performance to standard RIA and ELISA. These findings open avenues for widespread use of the ADAP assay in future general population screening programs to detect children at risk of developing T1D.</p>\",\"PeriodicalId\":19797,\"journal\":{\"name\":\"Pediatric Diabetes\",\"volume\":\"2024 \",\"pages\":\"4238394\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-03-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12016989/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pediatric Diabetes\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1155/2024/4238394\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Diabetes","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1155/2024/4238394","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Detection of Islet Autoantibodies in Whole Blood by Antibody Detection by Agglutination-PCR (ADAP) Technology Is Sensitive and Suitable for General Population Screening Programs.
Background: Detection of type 1 diabetes (T1D) at the preclinical stage is possible by detecting islet autoantibodies (IAs) years before the appearance of symptomatic diabetes. The Antibody Detection Israeli Research is a general population screening program searching for children with multiple IAs who are at risk of developing T1D. IAs are measured in capillary or venous whole blood (WB) samples using the novel ultrasensitive antibody detection by agglutination-PCR (ADAP) technology.
Objective: To assess the accuracy and reliability of the ADAP assay in venous and capillary WB.
Materials and methods: In total, 50 children with T1D and 50 healthy controls participated in the study. Venous and capillary blood samples were drawn from participants with T1D, while only venous blood was drawn from the controls. The ADAP assay in venous and capillary blood was compared to the currently used assays in their ability to detect glutamic acid decarboxylase (GADA), islet antigen-2 (IA-2A), and insulin autoantibodies (IAAs).
Results: The area under the curve using the receiver operating characteristic curves was comparable between the ADAP assay in WB and standard enzyme-linked immunosorbent assay (ELISA)/radioimmunoassay (RIA) for all three IAs GADA 0.946 (95% CI: 0.900-0.991) vs. 0.949 (0.906-0.992), P=0.873; IA-2A 0.747 (0.649-0.844) vs. 0.666 (0.587-0.744), P=0.106; IAA 1.000 (1.000-1.000) vs. 1.000 (1.000-1.000), P=1.000. The correlation between the levels of IA in venous and capillary WB using ADAP was R2 = 0.958 (P < 0.01), R2 = 0.943 (P < 0.01), and R2 = 0.711 (P < 0.01) for GADA, IA-2A, and IAA, respectively. IA levels in venous and capillary WB using ADAP were comparable without a proportional bias in Bland-Altman's plots of agreement, suggesting the two methods may be used interchangeably.
Conclusions: The ADAP assay is reliable in detecting IA in venous and capillary WB samples with comparable performance to standard RIA and ELISA. These findings open avenues for widespread use of the ADAP assay in future general population screening programs to detect children at risk of developing T1D.
期刊介绍：
Pediatric Diabetes is a bi-monthly journal devoted to disseminating new knowledge relating to the epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes in childhood and adolescence. The aim of the journal is to become the leading vehicle for international dissemination of research and practice relating to diabetes in youth. Papers are considered for publication based on the rigor of scientific approach, novelty, and importance for understanding mechanisms involved in the epidemiology and etiology of this disease, especially its molecular, biochemical and physiological aspects. Work relating to the clinical presentation, course, management and outcome of diabetes, including its physical and emotional sequelae, is considered. In vitro studies using animal or human tissues, whole animal and clinical studies in humans are also considered. The journal reviews full-length papers, preliminary communications with important new information, clinical reports, and reviews of major topics. Invited editorials, commentaries, and perspectives are a regular feature. The editors, based in the USA, Europe, and Australasia, maintain regular communications to assure rapid turnaround time of submitted manuscripts.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
