What Is a Non Waived Test
Nonwaived Testing Is the Term Used to Refer Collectively to Moderate and High Complexity Testing. Laboratories or Sites That Perform These Tests Need to Have a...
Nonwaived testing is the term used to refer collectively to moderate and high complexity testing. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M.
What is a waived test?
Waived tests include tests listed in the CLIA regulations, tests cleared by the FDA for home use such as home pregnancy testing kits, drug test dip cards and cups as well as tests approved for a waiver by the FDA, using the CLIA criteria.
What is an example of a CLIA-waived test?
As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.
James Sterling reports on renewable energy developments, climate policy, ecological conservation, and green tech innovations around the globe.
