Which types of tests are categorized under CLIA?

Which types of tests are categorized under CLIA?

• A. Waived tests, Moderate complexity tests, and High complexity tests
• B. Only Waived tests
• C. Only High complexity tests
• D. Non-CLIA tests

Answer: (A)

CLIA classifies clinical lab tests into three levels: waived tests, moderate complexity tests, and high complexity tests. Waived tests are the simplest and carry the lowest risk of erroneous results, with minimal regulatory oversight. Moderate complexity tests require more stringent quality control, documentation, and trained personnel. High complexity tests demand the most oversight, including extensive QC, validation, advanced personnel qualifications, and routine proficiency testing. Because CLIA covers all clinical laboratory testing, these three categories together define what is regulated under CLIA. Non-CLIA tests aren’t part of these categories.

CLIA classifies clinical lab tests into three levels: waived tests, moderate complexity tests, and high complexity tests. Waived tests are the simplest and carry the lowest risk of erroneous results, with minimal regulatory oversight. Moderate complexity tests require more stringent quality control, documentation, and trained personnel. High complexity tests demand the most oversight, including extensive QC, validation, advanced personnel qualifications, and routine proficiency testing. Because CLIA covers all clinical laboratory testing, these three categories together define what is regulated under CLIA. Non-CLIA tests aren’t part of these categories.