Dilution linearity immunoassay development

The primary focus in the analytical considerations of immunoassays for macromolecules should be in the development phase. By thoroughly defining each component of the immunoassay in the first phase of the assay life cycle, the resulting validation plan should be concise and the validation process should be straightforward. Several facets of the assay defined in the late development stage, such as specificity and dilutional linearity, can appropriately be included in the final validation report. 

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