This USMS workshop is the first in a series to assess the nations needs in the area of standards and technologies for immunoassay-based measurements. In vitro diagnostic tests based upon antigen/antibody interactions are used extensively as aids in the diagnosis of cancer and most other diseases, including; autoimmune, cardiovascular, endocrine, gastrointestinal, infectious, metabolic, neurological and renal disorders. Two of the largest health problems in the country are autoimmune disease and cancer, which combined, affect almost half of all Americans. The determination of circulating autoantibodies has long been a part of clinical medicine in autoimmune disease and there are many FDA approved autoantibody tests currently marketed. Autoantibodies are fast becoming an important diagnostic tool in cancer as well, with millions of dollars in NIH funding directed toward autoantibody discovery for early diagnosis and prevention of cancer. The central technical feature shared by all autoantibody diagnostic assays is the capture of autoantibodies from serum using immobilized autoantigen. However, there is enormous variability in these tests that has led to confusion over results, variable degrees of confidence in their utility and even misdiagnosis of patients' disease. Part of the problem is that there are currently no autoantigen standard reference materials or protocols. In addition, there is little coordination between diagnostic developers, clinicians, and regulators regarding standards and best practices.

The USMS workshop aims to bring together leaders in autoantibody-based medical diagnostics, diagnostic testing, clinical laboratory medicine, and regulatory affairs to identify the fundamental and common metrology issues that underpin most antibody-based serodiagnostics. In addition, the workshop(s) will aim to foster partnerships and collaborations for development of the infrastructural metrology needed to insure scientifically sound autoantibody-based diagnostics.

Presentations from the "Developing New Standards for Autoantibody Measurement: Bringing Metrology to Serology" USMS Workshop