Interlaboratory Evaluation of Multiplex Autoantibody Assay Performance in the Islet Autoantibody Standardization Program 2024 Workshop
Authors' conclusion
Multiplex assays demonstrated good overall performance for detecting islet autoantibodies and discriminating case subjects from control subjects. However, interlaboratory variability and platform-specific recognition patterns necessitate further standardization efforts. While not directly tested in this workshop, the results suggest that sequential testing strategies using complementary platforms may be necessary to achieve the stringent specificity required when these assays are used in a screening context.
Study context
- Population
- Coded sera from individuals with new-onset T1D, blood donors with no diabetes and replicate samples; 15 laboratories, 19 multiplex assays19 assays · 15 labs · individuals with new-onset T1D 50 · blood donors with no diabetes 98 · replicate samples 3
- Participants
- 6 / 8 / 2 / 1 / 2
- Comparison
- Multiplex islet autoantibody assays across 5 formats
- Antibody-dependent agglutination PCR (ADAP)n = 6
- Bridge-ELISAn = 8
- Electrochemiluminescencen = 2
- Luciferase immunoprecipitation system (LIPS)n = 1
- Protein A luciferase/solid-phase capture LIPSn = 2
- Outcome
- Assay performance across all platforms
Methodological detailsinternational, multiplex assays, coded sera
- International
- Multiplex assays
- Coded sera
Performance
As reported in the abstract
- Median ROC-AUC across all platforms
- 0.98
- pAUC95 (theoretical maximum 0.05)
- 0.048
- Laboratory-reported sensitivity
- 86% to 96%
- Laboratory-reported specificity
- 81% to 100%
- Adjusted sensitivity at 99% specificity thresholds (eliminated most false positives without compromising sensitivity)
- 93-97%
Further findings
- Bridge-ELISA platforms demonstrated potential for universal cutoff standardization
- ADAP showed substantial interlaboratory threshold variation
Original publication
Interlaboratory Evaluation of Multiplex Autoantibody Assay Performance in the Islet Autoantibody Standardization Program 2024 Workshop. Diabetes Care. Published 23 January 2025. doi:10.
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