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What Does it Mean to be CLIA WAIVED?

CLIA WAIVED

If you’re not a medical practitioner, chances are you still may have observed the unmistakable CLIA WAIVED label on Drug Tests, Pregnancy Tests, or even Blood Test Devices.  What does it mean to be CLIA WAIVED?

What Does CLIA Mean?

CLIA Stands for Clinical Laboratory Improvement Amendments.  These are regulations that were put in place to establish quality standards for lab testing performed on specimens. These specimens include blood, tissue or body fluid.  ConfirmedBiosciences.com comments:

Under CLIA provisions, all clinical laboratories in the United States that perform testing on human specimens – such as tissue, blood, and other body fluids – for the purpose of providing information to be used for the diagnosis, treatment, prevention, prognosis or health assessment of a disease or medical condition are required to comply with the prescribed standards

All of the CLIA Waived tests are categorized by the FDA  into three CLIA categories

  • Waived tests
  • Tests of moderate complexity
  • Tests of high complexity

What is the Difference Between Waived and Nonwaived Testing?

Waived tests are considered simple tests that have a low risk of providing an incorrect result.  These waived tests are cleared by the FDA for home use and are approved for a waiver under the CLIA criteria.

The simplicity of the waived tests is not considered error-proof, however.  It’s important to note that throughout the testing process,  errors can occur if the administrator of the test is unfamiliar with the device, or perhaps does not follow the instructions properly.

Nonwaived tests refer to tests that are considered high complexity. Facilities that have these kinds of tests must meet the CLIA quality standards and be inspected and receive a CLIA certificate.

Why is it Important to Purchase CLIA Waived Tests?

If you are considering purchasing CLIA WAIVED tests, understand that the “waived” carries a meaning.  When a test is “waived” this means that the device or test is cleared by the FDA for home use.  This means that these tests and devices can be used in a medical environment as well as in the comfort of your own home.  Why is this important?

Many CLIA WAIVED tests include Drug Testing Kits, Blood Pressure Monitoring devices like Sphygmomanometers, or even glucose monitoring devices.  In fact, glucose monitoring devices are automatically

 waived because they are submitted to the FDA as over-the-counter devices intended for home, and sometimes mobile use.

Today, there are many advantages to utilizing  CLIA WAIVED tests and devices.  These products and kits can be used at home, or in a medical environment.

CLIA Waived Tests Can Be Used At Home

With CLIA Waived tests and devices, patients can safely use these without the aid of a medical professional.  This means that many will be able to spend less on medical expenses and save on costs associated with traveling to medical facilities.

Even more so, the widespread need for accessible Drug Testing Kits with regards to employment, law enforcement, and the criminal justice system now demands the accessibility of these CLIA WAIVED tests to the general public.  These devices can now be used in a non-laboratory setting.  Test results can be evaluated quickly and efficiently.

How Can I Purchase CLIA Waived Drug Tests?

12 Panel Now offers Drug Tests in Bulk, or for single use. If you are concerned about how you or someone you know will fare on a CLIA Waived Drug Test, this will be a fairly simple process that only takes a few minutes.  Our Single Use 12 Panel Urine Drug Test tests for 12 commonly abused drugs.

How Do You Use a Drug Testing Kit?

After the donor seals the urine in the leak-proof container, it is then handed off to the evaluator.  What makes the process streamlined is that the strips used to indicate the test results are sealed within the container.  For hygiene reasons, this is ideal. When it is time to view the test results, the evaluator simply peels away the outside label revealing the drug test strips with each individual result.

How Long Does it Take?

The test results within the Drug Test will show results within a few minutes.  Results should be evaluated within 5-8 minutes. Results should not be evaluated after 1o minutes.

The 12 Panel Drug Testing Kits are designed to detect 12 of the most abused and commonly used drugs. However, depending on your needs, you can purchase other kits that test for different drugs.  For instance, the 13 Panel Drug Testing Cup includes all the same drugs tested within a 12 Panel Drug Test with the addition of the drug Fentanyl (FYL).  There are also variants of the typical 12 Panel Drug Test that detect drugs like phencyclidine, or PCP.

If you have any questions or concerns regarding our product or wish to place an order, feel free to call us at (888) 936-6627

We’re  Here to Help!

Here at 12 Panel Now, we are happy to provide information and spread awareness regarding these topics and more!  Every Tuesday, we publish a Blog with information on current events, as well as insights regarding our products!  We also provide the nation’s most affordable Drug Testing Supplies, including Drug Testing Cups and Strips both for personal, and medical use.  If you have any questions or comments, please feel free to contact us or send us an email!

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