Description: Understanding the accuracy and the relationship with bias and imprecision is key to selecting the right cut-off and designing verification testing in the usable range. This knowledge is key to designing an assay to meet the intended purpose and supporting a successful regulatory submission. Reviewers need to clearly see how the intended purpose is supported by appropriate data. This includes having the correct acceptance criteria which will also be discussed during this session.
Learning Objectives:
Understand how allowable misclassification / accuracy is related to bias and imprecision.
Understand how appropriate testing is necessary to support the intended use/purpose
Understand how acceptance criteria for the various verification tests that are required to support a regulatory submission are derrived from the allowable misclassification / accuracy that must be achieved by the product given it's intended use.
