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This phase of the assay development project focuses on getting all of the analytical tests to pass while keeping or improving the sensitivity of the test.  In this phase the following concepts are important:

This is not a complete list and depending on the workflow of your device and your intended customer, there are additional studies that are needed.  

Additionally, if you have not characterized your antigen and antibody in depth, then there is some analytical work and process design work around these items that will start in this phase or earlier depending on how you are generating your raw biologics.