Technical Validation and Utility of an HLA Class II Tetramer Assay for Type 1 Diabetes: A Multicenter Study
Authors' conclusion
Our results demonstrate that the assay is reproducible and useful to characterize islet-specific T cells and identify correlations between T-cell measures and clinical traits.
Study context
- Population
- Clone-spiked specimen and replicate samples from T1D patients; exploratory cross-sectional set of 24 T1D patients24 T1D in cross-sectional set
- Comparison
- Single-center vs Multicenter
- Outcome
- Reproducibility of the HLA-DRA-DRB1*04:01 tetramer assay, target CV less than 30%
Methodological detailssingle-center and multicenter testing, exploratory cross-sectional sample set
- Single-center and multicenter testing
- Exploratory cross-sectional sample set
Performance
As reported in the abstract
Mean CV of T-cell measurements
- Influenza-specific, clone-spiked specimen, single-center
- 6%
- Influenza-specific, T1D samples, single-center
- 11%
- Influenza-specific, clone-spiked specimen, multicenter
- 20%
- Influenza-specific, T1D samples, multicenter
- 31%
- Islet-specific, single-center (clone-spiked; T1D samples)
- 14% and 23%
- Islet-specific, multicenter (clone-spiked; T1D samples)
- 23% and 41%
Further findings
Cross-sectional study (24 T1D patients)
- Relationships identified between T-cell frequencies and phenotype and disease duration, sex, and autoantibodies
- A large fraction of islet-specific T cells exhibited a naive phenotype
- Exploratory
Original publication
Technical Validation and Utility of an HLA Class II Tetramer Assay for Type 1 Diabetes: A Multicenter Study. J Clin Endocrinol Metab. Published 20 July 2023. doi:10.
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