What does LDT mean in LABORATORY

An LDT is a medical diagnostic or screening test that is designed, manufactured, and used within a single laboratory. It has not been approved or cleared by the FDA.

FDA does not regulate Laboratory Developed Tests (LDTs). Each individual laboratory develops their own tests from supplies and services provided commercially or developed internally. The tests are then validated according to standards set and monitored by professional organizations such as the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA).

Risk can arise from using an LDT if its performance characteristics have not been properly evaluated and documented before being implemented in the laboratory setting. Moreover, the results of an LDT may lack consistency due to variations in reagents, calibrators, proficiency testing, personnel training, etc., making it difficult to compare findings between different laboratories.

Health care providers often use them as a tool to help diagnose patients more quickly than traditional tests which require FDA approval. Furthermore, they are beneficial when standard testing fails to provide conclusive diagnosis results due to rare disease states or new mutations of existing diseases. In addition, they also provide health care providers with options when other standard tests carry other complications or risks that may be difficult for certain patient populations such as those with immune deficiencies or serious allergies.

Typically hospital-based laboratories offer laboratory developed tests due to their access to researchers and pathologists who are knowledgeable about molecular diagnostics techniques; however specialized independent diagnostic laboratories also offer these services on a wider scale due to economies of scale incurring lower costs per test.