Validation of New Tests

Validating new tests is a recurring problem that pathologists face. The field of diagnostic medicine has a high rate of innovation and the laboratories need to adapt and implement new tests to address clinical needs and remain relevant. Validation ensures that the test performs as expected and satisfies the requirements of the lab, manufacturer, and regulatory bodies.The validation process requires the test to fulfill the requirements of its specific intended use through objective measures. The tests need to satisfy these requirements and they need to do it consistently. This process has three steps: define performance goals, assess error and finally compare the error with the goals. In this chapter, we will explain the steps involved in validation of new tests and explain the objective measurements that are needed for validation.

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