Autoimmune diseases are chronic debilitating conditions that collectively affect 5 to 8 % of the US population. The high prevalence of autoimmune diseases and the recognition that individuals who develop organ-specific autoimmune conditions have a high likelihood of developing additional autoimmune disorder(s) calls for the development of new technologies that can measure multiple immune reactivities simultaneously in a small sample volume. Detection of these diseases before onset or at early stages can help in making effective treatment decisions. Although multiplexing of up to 13 relevant assays for systemic autoimmune diseases has been achieved, broader panels have not been developed to assess the range of organ-specific autoimmune diseases such as Type 1 Diabetes and Celiac disease. Furthermore, no multiplexed assay panels exist that use a bridging immunoassay format, which provides higher assay specificity as compared to classical serological assay formats. The goal of the proposed program is to develop a novel, highly sensitive, and specific solution-based multiplexed bridging immunoassay panel that can simultaneously detect patient autoantibodies for 25 different autoimmune reactivities relevant to at least 12 major organ-specific autoimmune diseases. The multiplexed autoantibody detection panel will use sensitive Meso Scale Diagnostics, LLC. (MSD) MULTI-ARRAY technology. Our collaborators at the University of Florida, Dr. W.E. Winter and D. Pittmann, will provide their extensive expertise in clinical laboratory assessment of autoimmune diseases related to obesity, diabetes and the metabolic syndrome, and will provide high quality case and control samples for use in panel development, testing, and validation.

Public Health Relevance

The goal of this project is to develop blood tests that will identify patients who will develop, or have developed, any of twelve organ-specific autoimmune diseases, such as Type 1 Diabetes, Graves' disease and Celiac disease. The diagnostic tests developed using MSD's highly sensitive multiplex technology will enable doctors to move away from current approaches that use much larger amounts of patient samples to measure biomarkers individually and usually involve use of radioactivity.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24AI118660-04
Application #
9517690
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Bourcier, Katarzyna
Project Start
2015-07-06
Project End
2020-06-30
Budget Start
2018-07-01
Budget End
2019-06-30
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Meso Scale Diagnostics, LLC
Department
Type
DUNS #
113033224
City
Rockville
State
MD
Country
United States
Zip Code
20850