Under CLIA, which category includes tests that are simple to perform and carry a low risk of erroneous results?

• A. Nonwaived test
• B. Profile
• C. Waived test
• D. Qualitative test

Answer: (C)

Under CLIA, tests are grouped by how complex they are and how much oversight they need. The category that fits “simple to perform and low risk of erroneous results” is the waived category. Waived tests are specifically designed to be easy to perform with minimal training, use straightforward procedures, and have a proven very low chance of giving incorrect results. Because of that safety and simplicity, they carry the least regulatory burden and can be used in many settings outside a traditional lab, as long as the facility has a certificate of waiver. In contrast, nonwaived tests are more complex and require stricter quality control and training. A profile isn’t a CLIA category, and qualitative just describes the kind of result, not the regulatory level.