What type of test is a CLIA waived test?

A CLIA waived test refers to a specific category of diagnostic tests that meet minimal standards for complexity, allowing them to be performed in a variety of settings, including physician offices and clinics, without the need for specialized laboratory infrastructure. These tests are designed to be simple and easy to use, which reduces the risk of error when performed by individuals without extensive training in laboratory procedures.

The manual test for urine HCG, which checks for the presence of the hormone human chorionic gonadotropin often associated with pregnancy, is an example of a CLIA waived test. Such tests provide important and immediate results that can assist in clinical decision-making without requiring complex protocols or extensive laboratory resources. The emphasis on simplicity and reliability is central to the functionality of CLIA waived tests, making them suitable for quick assessments in varied healthcare settings. This aligns with the purpose of CLIA waiver regulations, aiming to enhance access to essential diagnostic services while maintaining a level of quality assurance.