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Standardization of autoantibody testing: a paradigm for serology in rheumatic diseases
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Journal Article
Standardization of autoantibody testing: a paradigm for serology in rheumatic diseases
2014
Overview
Key Points
Autoantibody measurement is required for the adequate diagnosis and management of systemic autoimmune rheumatic diseases
The advent of new techniques, as well as the increasing number of autoimmune diagnostic laboratories, raises the issues of assay variability and reproducibility
As a consequence, harmonization of the available assays is becoming increasingly urgent
The availability of suitable reference material for calibration and quality control is emerging as a valuable tool for increasing assay reliability
Initiatives for harmonization of testing have been started by several international committees and organizations
Autoantibody testing is key for the diagnosis, classification and management of systemic autoimmune rheumatic diseases; however, issues regarding the reproducibility and reliability of these tests currently limit their usefulness. Approaches to harmonize autoantibody tests, including the development of technical guidelines and the availability of suitable reference materials for calibration and quality control, are discussed in this Review.
Autoantibody measurement is an excellent tool to confirm the diagnosis of rheumatic autoimmune diseases. Hence, reliability and harmonization of autoantibody testing are essential, but these issues are still a matter of debate. Intrinsic variability in analytes and reagents as well as heterogeneity of the techniques are the main reasons for discrepancies in inter-laboratory variations and reporting of test results. This lack of reliability might be responsible for wrong or missed diagnoses, as well as additional costs due to assay repetition, unnecessary use of confirmatory tests and/or consequent diagnostic investigations. To overcome such issues, the standardization of autoantibody testing requires efforts on all aspects of the assays, including the definition of the analyte, the pre-analytical stages, the calibration method and the reporting of results. As part of such efforts, the availability of suitable reference materials for calibration and quality control would enable the development of a reliable reference system. Strong-positive sera from patients have been used as reference materials in most of the autoantibody assays for rheumatic diseases; however, antigen-affinity-purified immunoglobulin fractions or in some cases reliable monoclonal antibody preparations offer more adequate tools for standardization. Systematic assessments of reference materials are currently underway, and preliminary results appear to be encouraging.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
