What Tests are CLIA Waived?

CLIA (Clinical Laboratory Improvement Amendments) waived tests are tests that the United States Food and Drug Administration (FDA) clears according to CLIA conditions. If these tests for home use satisfy the CLIA conditions this is also known as a CLIA waiver. But, when asking what tests are CLIA waived, what exactly does “waived” mean? Let’s take a look!

 

 

What is not considered a CLIA Waived Test?

A test that hasn’t been CLIA-waived means that it hasn’t passed any CLIA conditions. Be careful that not all in-vitro drug tests are CLIA waived; if a CLIA waiver is not mentioned in the product description, it is likely not CLIA Waived.

Do not assume that a drug testing product line is CLIA Waived as this is typically only the case for detailed specifications. Drug test CLIA waivers are difficult to get, expensive, and time-consuming.

In order to ensure that there is no harm to the patient, many elements go into the test's quality and accuracy. The manufacturer and the product are unique to the CLIA waiver. 

The saying, “you get what you pay for” is true when it comes to at-home CLIA-waived drug tests. So, bear that in mind when choosing the proper item. Risk and liability are common concerns, as we all know.

A trusted brand with a solid reputation like Exploro is always the best option when trying to decide which CLIA waived urine drug test kits are best for you.

Why are CLIA Drug Tests Better?

CLIA waived urine tests in this context refer to using and testing outside of a CLIA-certified laboratory. This means that if a test is CLIA-waived, a person or organization that is not federally certified to test and report on human specimen testings may report on the findings of such tests. 

The FDA's CLIA waiver mandates that the test system retain a minimal risk of mistake or incorrect results and that the test be straightforward and understandable. 

The test methodology used for CLIA waived testing is not 100% error-free, but can only be deemed CLIA-Waived if it satisfies the FDA standards set forth by the CLIA statute.

All conditions stated in the CLIA law were established back in 1988 in the Public Health Services Act. The CDC states that the CLIA law is “...an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988. The law continues to be cited as CLIA ’88 as named in the legislation.”

Tests may be exempt from regulatory scrutiny if they comply with the specifications set forth in this statute. Regulations to implement CLIA were released on February 28, 1992.

If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. On February 28, 1992, regulations were published to implement CLIA.

Who Can Perform a CLIA Waived Test?

Anyone may use tests and testing kits that have CLIA waivers. With a CLIA-waived test system, neither the operator nor the test subject must be in a licensed laboratory. Also, there’s no need for a medical or clinical license required for the administrator to administer the test. 

As a result, organizations or individuals who require test results can conduct the tests themselves. They can read or report on the results without having to travel to a clinical lab or ship the test system there for analysis and results.

According to the Department of Health, “You should use a CLIA Waived Drug Test when testing for diagnosis, prevention, treatment of disease, impairment of, or assessment of health.”

Because of the savings of time, money, and effort, more people, systems, and processes can now test human specimens.

Types of CLIA Tests

Waived tests that are approved for use at home are essentially deemed safe tests as a whole. In other words, if these tests are simple to use and comprehend when the user complies with the producers' recommendations, they are waived. 

On the other hand, tests with a moderate to a high level of complexity are non-waived. In this way, they still call for clinical settings, accredited labs, and licensed doctors. The following tests typically are CLIA-waived and follow specific requirements:

• Drug tests (urine, hair, saliva)
• Alcohol tests (urine, breathalyzer, salvia)
• Pregnancy tests (urine)
• Virus/disease tests (COVID-19 and various other diseases)
• Blood glucose monitors
• Health screening (urinanalyse)

Visit here to view the complete list of testing systems with FDA approval and CLIA Waived status.

The FDA says that a laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of or assessment of health.

How to Use CLIA Waived Tests

Each test has its own set of guidelines and instructions and varies slightly from the others. The most important factor in securely performing and administering CLIA waived tests is to carefully and accurately follow the directions. 

The type of test and the type of human specimen sample affect how the results are interpreted (whether it is urine, saliva, or something else). Keep in mind that the manufacturer's recommendations and instructions must be followed step by step when interpreting test findings. 

For example, all Exploro tests come with comprehensive instructions for each test on how to do the rapid THC urine test and how to interpret the results.

You can find more information on CLIA waived tests at http://www.fda.gov/cdrh/clia/cliaWaived.html.  

To Sum it Up

Now that you know everything about CLIA waived tests, you can stop asking yourself “what are CLIA waived tests?” Depending on the type of test, your field of work, requirements given to you by an employer, etc., using a CLIA waived test is the best decision. Not only for its accurate results but also for its legitimacy when it comes to determining critical information i.e. drug test results.