What is a waived test?
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 CLIA waived test mean?
As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver.
What are the 3 types of CLIA waivers?
CLIA regulatory requirements classify testing into three categories: high complexity, moderate complexity and waived.
Is urine hCG a CLIA waived test?
QUICKVUE hCG-Urine Test, CLIA Waived, 25 tests/kit. A sensitive immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. Detects 25 mIU/mL hCG in urine. Results in 3 minutes or less.
Is PT INR a CLIA waived test?
Currently the CLIA-waived hematology and coagulation POC devices only test for hemoglobin (Hb), hematocrit (Hct), and prothrombin time/international normalized ratio (PT/INR).
What would be detected in a CLIA waived pregnancy test?
The all new CLIAwaived, Inc. Pregnancy Test (Cassette) is a qualitative immunoassay for the detection of human chorionic gonadatropin (hCG) in human urine for the early detection of pregnancy. hCG is a hormone produced by the placenta, which, in normal subjects, provides an early indication of pregnancy.
What CLIA waived testing can be done for pregnancy?
By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.
What do you need to know about waived testing?
CLIA certification. Each site offering only waived testing that is not included under any other type of CLIA certificate must obtain a CLIA CW before testing patient specimens.
What is waived testing means?
A waived test is one that is a “simple laboratory procedure which…has an insignificant risk of erroneous result.”
What is considered a CLIA waived test?
CLIA-Waived Testing Explained. On February 28, 1992, regulations were published to implement CLIA. Waived tests were defined as simple laboratory procedures that are cleared by the FDA for home use and that incorporate methodologies that are so easy and accurate that it is unlikely that mistakes would occur.
What tests are CLIA waived?
There are specific tests which have been CLIA waived. These are: Urinalysis tests performed using a tablet or a dipstick: These include tests to ascertain the presence of protein, urobilinogen, hemoglobin, bilirubin, nitrite, pH, glucose levels, leukocytes, ketone, specific gravity etc.
