Antigens are a key component of many IVD tests and are often used as controls to confirm that a test is performing as it should. For example, positive control wells in an IVD ELISA may be spiked with a known concentration of the protein of interest and used in conjunction with negative control wells to define the assay window. Antigens are also widely used to generate standard curves that provide a reference against which the concentration of the analyte in the test sample can be determined.
To be incorporated into an IVD test, Antigens undergo rigorous validation to guarantee product safety and efficacy. Not only must IVD grade Antigens demonstrate high purity, but they may also be required to meet defined functional specifications depending on the nature of the test. Since recombinant technology offers extremely tight process control, IVD grade Antigens are often produced by recombinant methods to ensure a reliable and consistent supply.
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