Recombinant Antibodies as Standards for Immunodiagnostic Assays

performance of immunodiagnostic assays and can vary from lab to lab according to factors such as assay reagents used, variation in the level of automation, operator experience and sample throughput. The quality and stability of assay components are critical to success. An important choice during assay development is the source of control and/or calibrator material and its standardization. Lack of consistency of this assay component makes it difficult to compare results from clinical studies performed by different personnel using different kits at different times. The classical choice for controls and calibrators in autoimmune assays is human disease state sera. However, there are known drawbacks to using sera to standardize assays, including obtaining it in sufficient quantity and ensuring consistency of long-term supply. Additionally, the polyclonal nature of sera means that it contains several different antibodies with a range of affinities, potentially causing variation from batch to batch of sera selected.