Tests that are very simple or pose no reasonable risk of harm to the patient if performed incorrectly are classified as which?

• A. Waived test
• B. Nonwaived test
• C. Definitive test
• D. Reference or gold standard

Answer: (A)

Under CLIA, tests are grouped by how simple they are and the risk of harm if performed incorrectly. Tests that are very straightforward and pose little or no risk to the patient are designated as waived tests. They can be done in nontraditional lab settings and typically require only basic training and the manufacturer’s instructions. This is why the correct label for such tests is “waived.” Concepts like a definitive or gold-standard test refer to the most accurate method for diagnosis and are often more complex and higher risk, so they aren’t classified as waived. Nonwaived tests are more complex, needing skilled personnel and stricter quality controls.