Under CLIA, non-waived quantitative tests require how many control levels per day?

• A. One
• B. Two
• C. Three
• D. Four

Answer: (B)

Under CLIA, non-waived quantitative tests require two control levels per day to verify that the assay is performing accurately across its measuring range. Using a low-level and a high-level control material helps catch issues that might affect different parts of the range, such as bias or drift that only appears at higher concentrations or at lower ones. This dual-level approach strengthens confidence that results are reliable for clinical decision values. If these controls fall outside acceptable limits, the run is not reported and the issue is investigated and repeated. While more controls can be run, the standard requirement is at least two levels daily for these quantitative tests.