Impact of Sample Type on ADAP-Based Autoantibody Detection for Type 1 Diabetes Population Screening
Authors' conclusion
Pancreatic autoantibody detection in whole blood with ADAP provides a stable and more efficient diagnostic solution for T1D population screening, with simplified preparation, low-volume requirements, and high diagnostic consistency comparable with serum-based assays.
Study context
- Population
- Patients with stage 3 T1D and healthy controls previously studied by radiobinding assay (RBA); IAA, glutamate decarboxylase (GADA), IA2A and ZnT8A analysed by Antibody Detection by Agglutination-PCR (ADAP)
- Participants
- 171 vs 95
- Comparison
- ADAP vs RBA for T1D autoantibody detection; ADAP across serum, plasma, EDTA whole blood and dried blood spot (DBS)
- Stage 3 T1Dn = 171
- Healthy controlsn = 95reference
- Outcome
- ADAP detection of ≥2 autoantibodies in serum
Performance
As reported in the abstract
Sensitivity
87.1%
Specificity
100%
Concordance with RBA (Cohen's kappa)
0.90
Further findings
ADAP concordance across sample types
- Whole blood showed high agreement with serum, a consistent alternative
- DBS had reduced concordance, leading to fewer positive detections; potential bias for T1D screening
Autoantibody stability in unrefrigerated whole blood
- IAA stable for up to
- 7 days
- GADA, IA2A and ZnT8A stable for up to
- 20 days
- Stable after freeze-thaw cycles
- 4
Original publication
Impact of Sample Type on ADAP-Based Autoantibody Detection for Type 1 Diabetes Population Screening. Diabetes Technol Ther. Published 4 November 2025. doi:10. 1177/ 15209156251390835
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