Cargando…

Effective assay technologies fit for large-scale population screening of type 1 diabetes

While worldwide prevention efforts for type 1 diabetes (T1D) are underway to abrogate or slow progression to diabetes, mass screening of islet autoantibodies (IAbs) in the general population is urgently needed. IAbs, the most reliable biomarkers, play an essential role in prediction and clinical dia...

Descripción completa

Detalles Bibliográficos
Autores principales: Jia, Xiaofan, Yu, Liping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012058/
https://www.ncbi.nlm.nih.gov/pubmed/36992730
http://dx.doi.org/10.3389/fcdhc.2022.1034698
_version_ 1784906537624403968
author Jia, Xiaofan
Yu, Liping
author_facet Jia, Xiaofan
Yu, Liping
author_sort Jia, Xiaofan
collection PubMed
description While worldwide prevention efforts for type 1 diabetes (T1D) are underway to abrogate or slow progression to diabetes, mass screening of islet autoantibodies (IAbs) in the general population is urgently needed. IAbs, the most reliable biomarkers, play an essential role in prediction and clinical diagnosis of T1D. Through laboratory proficiency programs and harmonization efforts, a radio-binding assay (RBA) has been well established as the current ‘gold’ standard assay for all four IAbs. However, in view of the need for large-scale screening in the non-diabetic population, RBA consistently faces two fundamental challenges, cost-efficiency and disease specificity. While all four IAbs are important for disease prediction, the RBA platform, with a separate IAb test format is laborious, inefficient and expensive. Furthermore, the majority of IAb positivity in screening, especially from individuals with single IAb were found to be low risk with low affinity. It is well documented from multiple clinical studies that IAbs with low affinity are low risk with less or no disease relevance. At present, two non-radioactive multiplex assays, a 3-assay ELISA combining three IAbs and a multiplex ECL assay combining all four IAbs, have been successfully used as the primary methods for general population screenings in Germany and the US, respectively. Recently, the TrialNet Pathway to Prevention study has been organizing an IAb workshop which aims to analyze the 5-year T1D predictive values of IAbs. A T1D-specific assay with high efficiency, low cost and requiring low volume of sample will definitely be necessary to benefit general population screening.
format Online
Article
Text
id pubmed-10012058
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-100120582023-03-28 Effective assay technologies fit for large-scale population screening of type 1 diabetes Jia, Xiaofan Yu, Liping Front Clin Diabetes Healthc Clinical Diabetes and Healthcare While worldwide prevention efforts for type 1 diabetes (T1D) are underway to abrogate or slow progression to diabetes, mass screening of islet autoantibodies (IAbs) in the general population is urgently needed. IAbs, the most reliable biomarkers, play an essential role in prediction and clinical diagnosis of T1D. Through laboratory proficiency programs and harmonization efforts, a radio-binding assay (RBA) has been well established as the current ‘gold’ standard assay for all four IAbs. However, in view of the need for large-scale screening in the non-diabetic population, RBA consistently faces two fundamental challenges, cost-efficiency and disease specificity. While all four IAbs are important for disease prediction, the RBA platform, with a separate IAb test format is laborious, inefficient and expensive. Furthermore, the majority of IAb positivity in screening, especially from individuals with single IAb were found to be low risk with low affinity. It is well documented from multiple clinical studies that IAbs with low affinity are low risk with less or no disease relevance. At present, two non-radioactive multiplex assays, a 3-assay ELISA combining three IAbs and a multiplex ECL assay combining all four IAbs, have been successfully used as the primary methods for general population screenings in Germany and the US, respectively. Recently, the TrialNet Pathway to Prevention study has been organizing an IAb workshop which aims to analyze the 5-year T1D predictive values of IAbs. A T1D-specific assay with high efficiency, low cost and requiring low volume of sample will definitely be necessary to benefit general population screening. Frontiers Media S.A. 2023-01-23 /pmc/articles/PMC10012058/ /pubmed/36992730 http://dx.doi.org/10.3389/fcdhc.2022.1034698 Text en Copyright © 2023 Jia and Yu https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Clinical Diabetes and Healthcare
Jia, Xiaofan
Yu, Liping
Effective assay technologies fit for large-scale population screening of type 1 diabetes
title Effective assay technologies fit for large-scale population screening of type 1 diabetes
title_full Effective assay technologies fit for large-scale population screening of type 1 diabetes
title_fullStr Effective assay technologies fit for large-scale population screening of type 1 diabetes
title_full_unstemmed Effective assay technologies fit for large-scale population screening of type 1 diabetes
title_short Effective assay technologies fit for large-scale population screening of type 1 diabetes
title_sort effective assay technologies fit for large-scale population screening of type 1 diabetes
topic Clinical Diabetes and Healthcare
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012058/
https://www.ncbi.nlm.nih.gov/pubmed/36992730
http://dx.doi.org/10.3389/fcdhc.2022.1034698
work_keys_str_mv AT jiaxiaofan effectiveassaytechnologiesfitforlargescalepopulationscreeningoftype1diabetes
AT yuliping effectiveassaytechnologiesfitforlargescalepopulationscreeningoftype1diabetes