Abstract
Producing robust, certified, traceable reference material for autoantibody testing is a vital element in maintaining the validity of results that are generated in the daily clinical laboratory routine. This is a huge challenge because of the high number of variables involved in the detection and measurement of the autoantibodies. The production of such materials is time consuming and needs rigorous attention to detail; this is best achieved by an overarching independent body who will oversee the process in a “not for profit” manner. Much effort has been made to build international standards for quantitative and qualitative assays based on monoclonal antibodies, obtained from affinity purification and plasmapheresis. The big challenge is to respect individual differences in immune response to the same antigen. A promising ongoing initiative is the construction of pools with monospecific samples from different individuals.
Highlights
The availability of standards or reference materials is central to the generation of reliable and interpretable laboratory which, in turn are vital for accurate patient diagnosis and management
Analytes that present subtle variation from one individual to another poise a significant challenge to the building of reference material. This is the case for antibodies, where each individual mounts a polyclonal collection of immunoglobulins that share the property of binding to the antigen of interest
They differ regarding the target epitopes, avidity, isotype, etc. This is further complicated by the fact that the multiple available methods for autoantibody detection vary in the ability of detecting different types of immunoglobulins
Summary
Producing robust, certified, traceable reference material for autoantibody testing is a vital element in maintaining the validity of results that are generated in the daily clinical laboratory routine. This is a huge challenge because of the high number of variables involved in the detection and measurement of the autoantibodies. The production of such materials is time consuming and needs rigorous attention to detail; this is best achieved by an overarching independent body who will oversee the process in a “not for profit” manner.
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