Government and Professional Approval and Oversight
Though the reasons for developing new tests or methods may vary, it is important to note that the development of all new tests is highly regulated. Each new test must meet certain criteria before it is allowed to be used on patient samples. To understand this process of validation, it is helpful, first, to understand that there are essentially two main kinds of tests:
- Commercial tests are those that are manufactured and sold in volume as kits to laboratories or other healthcare facilities. The majority of lab tests fall into this category. In the U.S., commercial tests must be approved by the Food and Drug Administration (FDA) before they are marketed to labs. The specific approval process can vary with the type and complexity of the test. For more on these, see Part II.
- Laboratory-developed tests (LDTs) are those that are developed within a particular laboratory (sometimes called home-brewed tests). In general, the evaluation, validation, and use are confined to the laboratory that develops the test. Typically, these tests are developed because there is no commercial test available. For more on these, see Part III.
These two types of tests take somewhat different paths for validation and approval, but in each case, their development and use on patient samples is governed by sets of rules that ensure their accuracy and reliability. The Clinical Laboratory Improvement Amendment (CLIA 88) is part of federal law that regulates laboratory testing and the quality assurance programs that oversee their validation and use. Professional accrediting organizations such as the Joint Commission and the College of American Pathologists (CAP) also provide continuing oversight of laboratories and laboratory testing.