What is characterized as a CLIA-waived test?

A CLIA-waived test is characterized by being cleared by the FDA for home use with minimal risk. CLIA, or the Clinical Laboratory Improvement Amendments, allow certain simple tests that pose a low risk for error to be conducted in various settings, including at home. These tests typically produce accurate results with minimal training required for the individual administering the test. Examples include tests for blood glucose levels and certain infectious diseases.

The definition of CLIA waiver focuses on the simplicity and safety of the tests, meaning they should not require complex laboratory infrastructure or procedures, which aligns perfectly with the characteristics mentioned in the correct choice. This enables broader access to testing, especially for patients who may not be able to easily access healthcare facilities. The emphasis on minimal risk also helps in ensuring that the tests are suitable for self-administration, further increasing accessibility and convenience for users.