High throughput Point-of-Care assays for diabetes auto-antibody detection

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DESCRIPTION (provided by applicant): With the growing prevalence of diabetes, the ability to accurately and reliably diagnose diabetes in its earliest stages has become a public health priority. Early identification of T1D risk and the onset of autoimmunity provide the basis for a variety of major ongoing studies seeking to prevent or delay the disease. Investigators have used a combination of islet autoantibody positivity, autoantibody seroconversion, biomarkers of genetic susceptibility and beta cell functional assays as criteria to select individuals at high rik of developing T1D. However, current technology for identification of at risk individuals is costly, requires participation of research laboratories, and may not be suitable for public health screening that would ensue should effective preventative interventions be established. Population based screening of individuals would be required as the majority of new cases of T1D (~70-80 percent) have no affected relatives. The specific aim of the proposed collaborative research is to develop a high throughput - Point of care (POC) assay platform (reliable, accurate, cost-effective, highly sensitive and specific standardized having rapid turnaround time) for autoantibody detection for autoimmune diabetes diagnosis and follow-up. The immediate application of our proposed technology will be directed towards the development of a multiplexed, homogenous (no wash steps), sensor array specifically for the detection of four insulin auto-antibodies namely, Insulin auto-antibodies (IAA), glutamic acid decarboxylase (GAD65), IA-2 or ICA512 auto-antibodies, and ZnT8 auto-antibodies. PUBLIC HEALTH RELEVANCE: Methods for more efficient identification of individuals at risk of T1D who may be eligible for preventative intervention would include low cost, high-throughput, accurate and predictive assays and devices that could be used at the point of care level. Application of such technologies could facilitate and expedite testing when effective ways to prevent or delay T1D become available and would be essential for identifying individuals who can benefit from such treatments.