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Impact of Sample Type on ADAP-Based Autoantibody Detection for Type 1 Diabetes Population Screening
Inés Urrutia1,2, Maitane González-Arceo1, Begona Calvo1,3
1Biobizkaia Health Research Institute. Barakaldo, Spain.
Diabetes Technology & Therapeutics
|November 8, 2025
Summary
Antibody Detection by Agglutination-PCR (ADAP) in whole blood offers a stable and efficient method for type 1 diabetes (T1D) screening. This approach simplifies sample handling and preparation, providing diagnostic consistency comparable to serum-based assays.
Area of Science:
- Immunology
- Endocrinology
- Biotechnology
Background:
- Growing global interest in early-stage type 1 diabetes (T1D) necessitates efficient and affordable screening methods.
- Advanced analytical technologies like Antibody Detection by Agglutination-PCR (ADAP) improve sample handling, but optimal sample selection for large-scale screening remains challenging.
- Current screening designs require simplified collection and processing of blood-derived samples for T1D autoantibody detection.
Purpose of the Study:
- To evaluate the Antibody Detection by Agglutination-PCR (ADAP) assay for detecting T1D-related autoantibodies.
- To compare the performance of ADAP across various blood-derived samples (serum, plasma, whole blood, dried blood spot).
- To identify the optimal sample type for large-scale T1D screening using ADAP.
Main Methods:
- Analyzed autoantibodies (IAA, GADA, IA2A, ZnT8A) using ADAP in 171 T1D patients and 95 healthy controls.
- Compared ADAP performance with radiobinding assay (RBA) in serum for sensitivity and specificity.
- Assessed ADAP concordance across serum, plasma, EDTA-anticoagulated whole blood, and dried blood spot (DBS), and investigated whole-blood stability.
Main Results:
- ADAP demonstrated high sensitivity (87.1%) and specificity (100%) for T1D autoantibodies in serum, with strong concordance with RBA (Cohen's kappa 0.90).
- Whole blood analyzed by ADAP showed high agreement with serum, presenting a consistent alternative sample type.
- Dried blood spot (DBS) sampling showed reduced concordance, potentially biasing T1D screening results; however, whole blood autoantibodies remained stable for extended periods (7-20 days) unrefrigerated and after freeze-thaw cycles.
Conclusions:
- Detection of pancreatic autoantibodies in whole blood using ADAP offers a stable and efficient diagnostic solution for T1D population screening.
- This method simplifies sample preparation and requires low volumes, achieving diagnostic consistency comparable to serum-based assays.
- Whole blood ADAP analysis is a promising approach for large-scale T1D screening due to its logistical advantages and reliability.
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