When validating a test, which aspect must be confirmed?

When validating a test, it is essential to confirm whether the test performs as claimed. Validation involves demonstrating that the test accurately measures what it is intended to measure, which encompasses aspects such as sensitivity, specificity, and overall reliability. This process ensures that the results produced by the test are clinically relevant and can be trusted for diagnostic or treatment decisions.

While factors like FDA approval can indicate a level of trust in the test's development and safety, and the status of the laboratory can suggest reliability in the testing process, the core of validation lies in the actual performance of the test itself. Additionally, cost-effectiveness is important for practical aspects of test implementation and accessibility, but it does not directly address the scientific integrity or operational efficiency of the test being validated. Thus, confirming that the test performs as it claims is the fundamental element of a robust validation process.