Likewise, what is CLIA and what is its purpose?
In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.
What is a CLIA waived lab test?
CLIA waived tests are generally simple test that are non-technical. Pose no reasonable risk of harm to the patient if the test is performed incorrectly. Are cleared by the FDA for home use.
What does it mean if a test is CLIA waived?
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.