Pregnancy Test Directions

Is the Test You Need CLIA Waived?

When a test or a laboratory procedure is deemed CLIA waived, it means that the test is simple enough and innately accurate on its own. As long as the instructions for using the test are followed, the results will be correct and foolproof, and no harm will come out of it.

Many medical tests that we need to take, whether at a clinical laboratory or at home, are CLIA waived tests. But how would you know if this test is CLIA waived or not?

Understanding CLIA

The CLIA, or the Clinical Laboratory Improvement Amendments, is a set of regulations that the United States Congress passed in 1988. The goal of the CLIA is to establish and regulate the quality standards for testing in laboratories so that the tests would always be timely, reliable and accurate.

Supervision of the CLIA program is the primary responsibility of the Centers for Medicare and Medicaid Services (CMS). The categorization of how complex a particular test is, or whether the procedure should be a CLIA waived test, is done by the Food and Drug Authority.

How Does a Test Become CLIA Waived?

Under the CLIA regulations, a particular test must meet the CLIA requirements for it to become a CLIA waived test. These requirements, in general, are:

1. The test should be simple and accurate enough that no errors will be produced or encountered in the course of the test;

2. The test should pass the safety requirements of the FDA for home use; and

3. The test should not pose any harm to its user if the procedure was not followed correctly.

The FDA has nine types of tests that are automatically CLIA waived. These tests are:

1. Non-automated urinalysis using dipstick or tablet reagents particularly for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrites, pH, protein, specific gravity and urobilinogen

2. Ovulation Tests that make use of visual color comparisons

3. Urine pregnancy tests using visual color comparisons

4. Fecal occult blood

5. Blood glucose using FDA-cleared monitoring instruments

6. Spun microhematocrit

7. Non-automated testing for hemoglobin-copper sulfate

8. Non-automated testing for erythrocyte sedimentation rate

9. Hemoglobin tests using single analyte instruments that are self-contained and gives readouts from direct measurements

If a test does not automatically fall under the nine types named by the FDA for automatic CLIA waived testing status, the manufacturer of the test would have to apply for a certification of waiver from CMS. The same applies to laboratories that wish to conduct CLIA waived tests as well.

Resources You Should Check for CLIA Waived Tests

If you are using a particular product and you want to know if the test is CLIA waived, you can check out the following websites:

1. The CLIA Database. The FDA maintains a database that it updates monthly. You can search the name of the test on this database.

2. The List of CLIA Waived Tests. The FDA also has a list of every CLIA waived tests that it has certified since January 2000. This list is also updated regularly.

About the Author

Lena Butler, the author of Home Testing Kits a longer version of this article is located at Caffeine Testing: How Much Caffeine is in My Drink?, and resources from other home health and wellness testing articles are used such as Instant Caffeine Test Strips.

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