Development of a Simple Multiplex Electrochemiluminescence (ECL) Assay for Screening Pre-Type 1 Diabetes and Multiple Relevant Autoimmune Diseases

The presence of islet autoantibodies (iAbs) is currently the most reliable biomarker for type 1 diabetes (T1D). The current “gold” standard radio-binding assays that measure four major iAbs to insulin, IAA, GAD65, IA-2A and ZnT8, are laborious and do not fit for large-scale screenings. Around 40% of patients with T1D develop other autoimmune diseases like celiac disease, autoimmune thyroid disease, and so on. It is highly recommended to screen these closely related autoimmune diseases during T1D screening; however, there is no method available. Recently, on the platform of extensively validated high-sensitive and high-specific electrochemiluminescence (ECL) assay, we developed a multiplex ECL assay to combine up to 10 autoantibody assays into one single well with 5 μl of blood sample. It not only allows us to combine multiple iAbs into one but also makes it possible to simultaneously screen T1D and other multiple autoimmune diseases, which in turn facilitates large-scale screenings in the general population.