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.
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.
HLA Core Facility
Research and Clinical HLA Typing and DNA Extraction
The BDC HLA Core Facility is a CLIA and CAP certified laboratory and has been designated as a NIH/NIDDK North America HLA Core Laboratory for 2 decades, having served as the HLA typing laboratory for the Trialnet Study. We have also been serving the BDC Clinics and doing HLA typing for Clinical and research studies across the United States for more than 20 years. As well as HLA typing, we provide DNA extraction services from whole blood that is fresh or frozen, resulting in highly pure DNA for other downstream applications as well as HLA typing.
Cutting Edge Assay and Quality Control
Our HLA laboratory prides itself on producing HLA typing of the highest accuracy and consistency. We currently do hybrid capture Next Gen Sequencing (NGS) based typing which achieves the most precise results for 17 HLA alleles. We include previously typed consensus samples and blank samples in every run to ensure lack of contamination and specificity necessary for the highest quality results. Using the CAP Proficiency testing program and the UCLA Immunogenetics International DNA Exchange, we do 9 sets of samples per year that are measured against a consensus HLA.
Flexible Typing for Research Needs
As well as the NGS based hybrid capture assay, we also currently offer microbead assays using Luminex xMAP technology for research use only needs. If only one or two HLA alleles are needed this can be a cost effective way to acquire the data necessary for research to proceed. In addition, discounts can be arranged for batched research samples by prior agreement.
Research and Clinical HLA Typing and DNA Extraction
The BDC HLA Core Facility is a CLIA and CAP certified laboratory and has been designated as a NIH/NIDDK North America HLA Core Laboratory for 2 decades, having served as the HLA typing laboratory for the Trialnet Study. We have also been serving the BDC Clinics and doing HLA typing for Clinical and research studies across the United States for more than 20 years. As well as HLA typing, we provide DNA extraction services from whole blood that is fresh or frozen, resulting in highly pure DNA for other downstream applications as well as HLA typing.
Cutting Edge Assay and Quality Control
Our HLA laboratory prides itself on producing HLA typing of the highest accuracy and consistency. We currently do hybrid capture Next Gen Sequencing (NGS) based typing which achieves the most precise results for 17 HLA alleles. We include previously typed consensus samples and blank samples in every run to ensure lack of contamination and specificity necessary for the highest quality results. Using the CAP Proficiency testing program and the UCLA Immunogenetics International DNA Exchange, we do 9 sets of samples per year that are measured against a consensus HLA.
Flexible Typing for Research Needs
As well as the NGS based hybrid capture assay, we also currently offer microbead assays using Luminex xMAP technology for research use only needs. If only one or two HLA alleles are needed this can be a cost effective way to acquire the data necessary for research to proceed. In addition, discounts can be arranged for batched research samples by prior agreement.
Islet Autoantibody Tests
Insulin Autoantibodies (IAA):
A micro insulin autoantibody radiobinding assay with the result expressed as an index against the laboratory standard internal positive and negative controls. The patients using exogenous insulin will all be positive.
GAD65 Autoantibodies (GADA):
It is a NIH/NIDDK harmonized GAD65 autoantibody radiobinding assay with the result expressed as DK units/ml with a NIDDK standard curve. The test result is comparable with all ongoing NIH/NIDDK led national/international clinical trials like TrialNet, TEDDY study, etc.
IA-2 Autoantibodies (IA-2A):
NIH/NIDDK harmonized IA-2 autoantibody radiobinding assay with the result expressed as DK units/ml with a NIDDK standard curve. The test result is comparable with all ongoing NIH/NIDDK led national/international clinical trials like TrialNet, TEDDY study, etc.
ZnT8 Autoantibodies (ZnT8A):
A ZnT8 autoantibody radiobinding assay with the result is expressed as an index against the laboratory standard internal positive and negative controls.
Other Autoantibody Tests
Transglutaminase Autoantibodies (TGA):
TG is a well known autoimmune marker for Celiac disease and multiple studies have demonstrated that the TG levels are strongly associated with clinical disease onset by biopsy. Among the patients with type 1 diabetes, around 8-10% are TG positive. TG test is a radiobinding assay and the result is expressed as an index against the laboratory standard internal positive and negative controls.
21-Hydroxylase Autoantibodies (Hyd21):
Hyd21 is a specific autoimmune marker for Addison’s disease. Many patients were initially found to have the disease because of the autoantibody screening. Among the patients with type 1 diabetes, around 1-1.5% are Hyd21 positive. Hyd21 test is a radiobinding assay and the result is expressed as an index against the laboratory standard internal positive and negative controls.
HLA Typing:
We accept either whole blood (fresh or frozen) or DNA samples.
HLA DQA&B Typing
HLA DRB1 Typing
HLA DPA&B Typing
HLA DRB345 Typing
HLA A,B,C,E,F,G,H Typing
MICA&B Typing
All clinical diagnostic samples will be assigned our BDC LabID and PtID upon receipt. The patient information will be entered into our BDC laboratory main database including all test results. The database is secured and has back-up system through University of Colorado IT Services. All test results will be stored long-term and will be retrievable.
Turn-Around Time
Autoantibody Services: Within one to two weeks
HLA Services: Within two weeks
Location:
Barbara Davis Center
University of Colorado, Anschutz Medical Campus
1775 Aurora Court, 4th floor, Room M20-4201E
Aurora, CO 80045
Tel: 303-724-6809
Fax: 303-724-5811
Autoantibody/HLA contact personnel:
Liping Yu, MD, Principal Investigator & Core Director
Tel: 303-724-6808