CLIA-Waived Tests

Rapid diagnostic testing does not eliminate the need for lab testing services but they do minimize it. There will always be certain situations where a confirmatory lab test is a necessary step after receiving a preliminary test result. National Test Systems, now under Premier Biotech®, has access to state-of-the-art laboratories with end-to-end insights driven by technology. Premier Biotech owns and operates a CAP-accredited toxicology laboratory in Minneapolis, MN and an HHS/DOT-certified lab in Scottsdale, AZ. Both labs boast excellent turnaround times and constant innovation — two factors that are core to Premier Biotech’s success.

The window of detection is an extremely important aspect to consider when performing instant diagnostic testing especially when testing for drugs of abuse. Urine typically will have a longer window of detection than saliva ranging from a few days to weeks to even up to a month with certain substances like THC, but there are many factors that play a role in determining a substances' window of detection when using a urine specimen. The age, weight, and frequency and volume of consumption of the patient as well as the substance itself. Salvia specimens, while having accurate detection, will typically only have a window of detection of 24-48 hours after last use.

Depending on the type of program, you may need to use CLIA-Waived test devices. CLIA regulatory requirements vary according to the kind of test(s) each laboratory conducts. Tests are categorized as waived, moderate complexity or high complexity. With respect to CLIA applicability, the CLIA regulations do not differentiate between facilities performing provider-ordered testing and those performing non-provider-ordered testing. All facilities that meet the definition of a “laboratory” under the CLIA statute and regulations must obtain an appropriate CLIA certificate prior to conducting patient testing. Whether a test service is billed to Medicare has no bearing on CLIA applicability. Please review our CLIA information here or call us to chat with an expert.