Is the Test You Need CLIA Waived?

When a test or a laboratory procedure is deemed1. Non-automated urinalysis using dipstick or tablet
CLIA waived, it means that the test is simplereagents particularly for bilirubin, glucose,
enough and innately accurate on its own. As longhemoglobin, ketone, leukocytes, nitrites, pH,
as the instructions for using the test are followed,protein, specific gravity and urobilinogen
the results will be correct and foolproof, and no2. Ovulation Tests that make use of visual color
harm will come out of it.comparisons
Many medical tests that we need to take,3. Urine pregnancy tests using visual color
whether at a clinical laboratory or at home, arecomparisons
CLIA waived tests. But how would you know if4. Fecal occult blood
this test is CLIA waived or not?5. Blood glucose using FDA-cleared monitoring
Understanding CLIAinstruments
The CLIA, or the Clinical Laboratory Improvement6. Spun microhematocrit
Amendments, is a set of regulations that the7. Non-automated testing for hemoglobin-copper
United States Congress passed in 1988. The goalsulfate
of the CLIA is to establish and regulate the quality8. Non-automated testing for erythrocyte
standards for testing in laboratories so that thesedimentation rate
tests would always be timely, reliable and9. Hemoglobin tests using single analyte
accurate.instruments that are self-contained and gives
Supervision of the CLIA program is the primaryreadouts from direct measurements
responsibility of the Centers for Medicare andIf a test does not automatically fall under the nine
Medicaid Services (CMS). The categorization oftypes named by the FDA for automatic CLIA
how complex a particular test is, or whether thewaived testing status, the manufacturer of the
procedure should be a CLIA waived test, is donetest would have to apply for a certification of
by the Food and Drug Authority.waiver from CMS. The same applies to
How Does a Test Become CLIA Waived?laboratories that wish to conduct CLIA waived
Under the CLIA regulations, a particular test musttests as well.
meet the CLIA requirements for it to become aResources You Should Check for CLIA Waived
CLIA waived test. These requirements, in general,Tests
are:If you are using a particular product and you want
1. The test should be simple and accurate enoughto know if the test is CLIA waived, you can
that no errors will be produced or encountered incheck out the following websites:
the course of the test;1. The CLIA Database. The FDA maintains a
2. The test should pass the safety requirementsdatabase that it updates monthly. You can search
of the FDA for home use; andthe name of the test on this database.
3. The test should not pose any harm to its user2. The List of CLIA Waived Tests. The FDA also
if the procedure was not followed correctly.has a list of every CLIA waived tests that it has
The FDA has nine types of tests that arecertified since January 2000. This list is also
automatically CLIA waived. These tests are:updated regularly.