Autoantibody/HLA Core Facility

Serving the World's Research and Clinic Needs
BDC Autoantibody/HLA Core Facility is a CLIA and CAP certified laboratory and has been designated as a NIH/NIDDK North America Autoantibody/HLA Core Laboratory for two decades offering services to national and international type1 diabetes clinical trials like DPT-1 (Diabetes Prevention Trial – Type 1), T1DGC (Type 1 Diabetes Genetic Consortium), TrialNet, TEDDY (The Environmental Determinants of Diabetes in the Young) Study, ITN (Immune Tolerance Network) and many other local and international clinical trials. As a CLIA certified clinical laboratory, we’ve also been serving the clinics here at the Barbara Davis Center for Diabetes as well as clinics and hospitals across the United States for the last 23 years.

Cutting Edge
Recently, the assays for GAD65 and IA-2 autoantibodies have been harmonized through a significant effort from the NIH/NIDDK Diabetes Autoantibody Harmonizing Committee using a standard assay protocol with a common antibody unit expressed as DK units/ml (NIDDK units). This made it possible for antibody test results to be comparable among all of the ongoing national/international trials between different laboratories worldwide. BDC’s Autoantibody/HLA Core Facility is one of three international laboratories helping to accomplish these harmonized assay protocols.

Highest Quality
Performance of the highest quality, accuracy and consistency are the features of our core services. In addition to our own laboratory’s consistent quality assurance system, each national/international clinical trial project has its own quality assurance system to monitor. Each laboratory’s performances by coded duplicate and confirmatory samples. In every International Diabetes Autoantibody Standardization Program Workshop (DASP Workshop) held every 18 months, our laboratory is always the top performer.

New Development
Recently, our laboratory developed a new non-radioactive autoantibody assay method with electrochemiluminescence (ECL) technology, which has been shown to have a higher sensitivity and specificity, especially for insulin autoantibodies. With this new technology, the assays for insulin and GAD65 autoantibodies have demonstrated the ability to differentiate the highrisk autoantibodies which are more diabetes associated from low risk and less disease associated antibodies. The latter appear as a single antibody or are transient in nature.