Laboratory Developed Tests must include what type of disclaimer text?

Laboratory Developed Tests (LDTs) are unique assays that are designed, manufactured, and used within a single laboratory, primarily for clinical diagnostics. The requirement for disclaimer text stems from the regulatory status of LDTs, which often operate outside of the strict regulations imposed on commercially marketed diagnostic tests by the FDA.

The inclusion of standard LDT disclaimer text is essential as it informs users that the test has not undergone the same level of scrutiny and approval process as tests officially cleared or approved by the FDA. This is crucial for transparency, ensuring that healthcare providers and patients are aware that the test results may vary in reliability and validity compared to FDA-approved diagnostics.

This disclaimer typically emphasizes that the test is developed in accordance with CLIA regulations but does not meet the additional standards of FDA review, serving as a communication tool regarding the nature and development process of the test. The presence of this text helps to manage expectations and educate users about the context in which the LDT operates.