Complex tests that require skill to perform and interpret and are therefore regulated are described as:

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

Answer: (B)

Tests that require skill to perform and interpret fall into the nonwaived category, which covers moderate to high complexity assays. This category is regulated because mistakes in execution or interpretation can significantly affect patient care; labs must have suitably trained personnel, validated methods, strict quality control, proficiency testing, and regular inspections to ensure reliable results.

Waived tests are the simplest and carry minimal regulatory oversight, so they don’t describe the scenario in question. The terms definitive test or reference/gold standard describe the accuracy or the best available method for comparison, not the regulatory category of the test.