What type of test is Fecal Occult Blood (FOB) considered?

Fecal Occult Blood (FOB) testing is classified as a CLIA-waived test, which means it is recognized by the Clinical Laboratory Improvement Amendments (CLIA) as being simple enough that it can be performed in a non-laboratory setting, such as a physician's office or clinic. These tests have low complexity and provides rapid results, allowing for easy screening for conditions such as colorectal cancer or other gastrointestinal issues at the point of care.

CLIA-waived tests require less rigorous regulatory control compared to more complex laboratory tests. They are designed to be user-friendly and produce accurate results when the manufacturer's instructions are followed. While confirmatory tests validate the presence of a condition following a screening, and comprehensive metabolic panels assess various metabolic and chemical components in the blood, these do not apply to FOB testing. Similarly, intrusive tests typically involve procedures that require entering the body, which does not describe the non-invasive nature of the FOB test. Thus, classifying FOB tests as CLIA-waived accurately reflects their operational context and regulatory status.