According to CLIA, what are the two categories of tests defined for POCT?

The correct choice highlights the classification of laboratory tests under the Clinical Laboratory Improvement Amendments (CLIA) regulations, which delineate tests into two main categories: waived tests and non-waived tests.

Waived tests are those that pose a low risk for an incorrect result and are simple to perform, requiring minimal training. This category allows for easier access to testing in various settings, including point-of-care environments, where quick decision-making is essential. Examples of waived tests include certain types of rapid diagnostic tests that are straightforward and reliable.

On the other hand, non-waived tests are more complex and may involve higher risks or require more sophisticated equipment and trained personnel. These tests need to follow stricter regulatory standards, including quality control measures and proper oversight, to ensure accurate results.

Understanding this categorization is crucial for health professionals involved in point-of-care testing, as it determines the regulatory requirements and protocols that must be followed depending on the type of test being performed.