Have you ever heard someone say: “This test is CLIA-Waived,” but do not really know what that means?
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof.
At HELIX DIAGNOSTIC we offer a wide variety of drug testing products to be used at home. Because of the many choices, we understand this can be a bit overwhelming as to which product to select. However, we offer this guide which will help you decide the best drug test to use for your specific situation. We have a product for every scenario, whether it is for:
-Testing at home
CLIA requirements apply to the clinical use of drug testing. This includes any entity that performs tests on materials derived from the human body in order to provide an assessment of the person’s health, information for diagnosis, and treatment or prevention of any impairment or disease. Any company performing a test for these set of purposes are considered by CLIA to be a laboratory, and must abide by CLIA regulations by registering with the CLIA Program if they want to receive the benefits.
How much does it cost?
$7.50 plus Savings & Offers
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Other regulations about CLIA-Waived Drug Tests:
The Clinical Laboratory Improvement Amendments were established in 1988 as a set of guidelines to specify which drug tests are to be CLIA-waived based on the complexity of the test performed. Tests that meet the requirements can be waived from regulatory oversight. Waived tests are defined as simple procedures that are cleared by the FDA for home use and labeled as easy to use and accurate enough that it’s unlikely any mistakes will occur. CLIA testing standards apply nationally and are provided through CMS (Center for Medicare and Medicaid Services).
Another regulatory requirement is that the test must pose no risk to the patient if the test were to be performed incorrectly. Quality standards for laboratories are established by CLIA to ensure reliability, accuracy, and timeliness of the patient’s test results.
Drug test dip cards are a great low-cost option if you don’t mind dipping the product into a collection cup to get the results. Dip cards are used frequently in all industries and we offer this product in the case that having a low cost is your highest concern.