What must a laboratory demonstrate for tests that are not FDA approved?

For tests that are not FDA approved, it is essential for a laboratory to demonstrate that they function as claimed. This means the laboratory must provide evidence that the test accurately detects or measures what it is intended to measure. This is particularly important in a clinical setting where the reliability and validity of test results can have significant implications for patient care and diagnosis.

Demonstrating that a test functions as claimed typically involves conducting rigorous performance assessments, including sensitivity, specificity, and reproducibility studies. These assessments help establish that the test yields consistent and reliable results, which is crucial when the test does not have the backing of FDA approval that may otherwise guarantee certain standards of performance.

While compliance with international standards, cost-effectiveness, and involvement in clinical trials can be valuable in the context of laboratory operations and evaluations, they do not directly address the primary need to validate the functionality of non-FDA approved tests. Thus, the focus remains on confirming that these tests perform accurately for the intended use.