In:
PLOS ONE, Public Library of Science (PLoS), Vol. 15, No. 11 ( 2020-11-13), p. e0242049-
Abstract:
Islet autoantibodies are predominantly measured by radioassay to facilitate risk assessment and diagnosis of type 1 diabetes. However, the reliance on radioactive components, large sample volumes and limited throughput renders radioassay testing costly and challenging. We developed a multiplex analysis platform based on antibody detection by agglutination-PCR (ADAP) for the sample-sparing measurement of GAD, IA-2 and insulin autoantibodies/antibodies in 1 μL serum. The assay was developed and validated in 7 distinct cohorts (n = 858) with the majority of the cohorts blinded prior to analysis. Measurements from the ADAP assay were compared to radioassay to determine correlation, concordance, agreement, clinical sensitivity and specificity. The average overall agreement between ADAP and radioassay was above 91%. The average clinical sensitivity and specificity were 96% and 97%. In the IASP 2018 workshop, ADAP achieved the highest sensitivity of all assays tested at 95% specificity (AS95) rating for GAD and IA-2 autoantibodies and top-tier performance for insulin autoantibodies. Furthermore, ADAP correctly identified 95% high-risk individuals with two or more autoantibodies by radioassay amongst 39 relatives of T1D patients tested. In conclusion, the new ADAP assay can reliably detect the three cardinal islet autoantibodies/antibodies in 1μL serum with high sensitivity. This novel assay may improve pediatric testing compliance and facilitate easier community-wide screening for islet autoantibodies.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0242049
DOI:
10.1371/journal.pone.0242049.g001
DOI:
10.1371/journal.pone.0242049.g002
DOI:
10.1371/journal.pone.0242049.g003
DOI:
10.1371/journal.pone.0242049.g004
DOI:
10.1371/journal.pone.0242049.t001
DOI:
10.1371/journal.pone.0242049.t002
DOI:
10.1371/journal.pone.0242049.t003
DOI:
10.1371/journal.pone.0242049.s001
DOI:
10.1371/journal.pone.0242049.s002
DOI:
10.1371/journal.pone.0242049.s003
DOI:
10.1371/journal.pone.0242049.s004
DOI:
10.1371/journal.pone.0242049.s005
DOI:
10.1371/journal.pone.0242049.s006
DOI:
10.1371/journal.pone.0242049.s007
DOI:
10.1371/journal.pone.0242049.s008
DOI:
10.1371/journal.pone.0242049.s009
DOI:
10.1371/journal.pone.0242049.s010
DOI:
10.1371/journal.pone.0242049.s011
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2020
detail.hit.zdb_id:
2267670-3
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