Simple laboratory tests which may be used by CLIA-waived laboratories including some doctor’s offices and emergency rooms. A CLIA-waiver does not allow tests to be sold direct to consumers or over the counter. CLIA-waived tests must employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible. In addition, for a test to be granted a CLIA-waiver the specimen needs to be ‘direct’ – i.e., little to no sample processing and there must be no need for the person running the test to interpret the results.
A test is granted a CLIA status at the time of clearance or approval of the test. These include CLIA high-complexity (can only be used in a CLIA high complexity lab), CLIA-moderate (may be used in a CLIA moderate or high-complexity lab) or CLIA-waived (may be used in any CLIA laboratory).