What type of test is a CLIA waived test?

A CLIA waived test is defined by the Clinical Laboratory Improvement Amendments as a type of test that is simple to perform and carries a low risk for an incorrect result. This means that these tests can often be carried out in a variety of settings, including physicians' offices and other non-traditional laboratory locations, without needing complex equipment or substantial training.

The manual test for urine HCG accurately fits within the category of CLIA waived tests, often used for pregnancy testing. These tests are designed to be straightforward, providing quick results with limited user intervention, making them accessible for healthcare providers who may not have extensive laboratory training.

Tests that require specialized training or complex procedures, or those requiring prior approval, would not qualify as CLIA waived tests. Instead, they are generally subject to more stringent regulation and oversight due to the greater potential for error and the need for professional expertise in their administration and interpretation.