Rapid Test Devices for Drug Screening

What are CLIA Waived Tests?
CLIA stands for Clinical Laboratory Improvement Amendments which are a set of regulations passed by the US government. The purpose is to set and control the standards for clinical laboratory testing on any specimen or sample derived from the human body. The mission of CLIA is to ensure that test results performed in a clinical laboratory are timely, accurate and reliable. A clinical laboratory as defined under the CLIA law is a place where tests on specimens taken from the human body are conducted for the purposes of diagnosing and treating a disease. The government agency that has jurisdiction over the CLIA is the CMS (Centers for Medicare and Medicaid Services). The CMS performs supervisory and regulating tasks including granting certificates for CLIA waived testing in approved laboratories. There are some kinds of lab tests that are considered to be CLIA waived. When a test is CLIA waived, it means that the test itself is so simple and accurate in itself that it is impossible to produce incorrect results in conducting them. A test can also be CLIA waived if it is proven that it does not do any harm to the human body. In addition, a test becomes automatically CLIA waived if the Food and Drug Authority has approved its use in homes or businesses. CLIA waived tests are safe as long as the instructions provided by their manufacturer are closely followed.

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