What You Need to Know…

Something you may have noticed while browsing our product catalogs and/or listings is that some of the tests have a designation of “CLIA Waived”, while others are designated as “FUO”. What do these two designations refer to, and how does it affect you? Let us look a little deeper and find out.

For the pure definitions, CLIA Waived refers to both “CLIA” – an acronym for Clinical Laboratory Improvement Amendments – and “Waived” – the complexity rating of the test in question. As for “FUO”, this is an acronym for Forensic Use Only. Of course, this still doesn’t really clarify anything, so let us continue.

With the goal of ensuring that “laboratory” testing of human specimens provide accurate, reliable, and timely patient test results, no matter where the test is performed, the Clinical Laboratory Improvement Amendments were passed in 1988. Almost all medical diagnostic device or service, under the purview of the FDA (Food & Drug Administration) and CMS (Centers for Medicare & Medicaid Services) and following the guidance of CLIA is rated based on the complexity of the test. In this context, complexity refers to the ease of an individual to collect the specimen, perform the test, and interpret the results with as little room for error as possible.

FDA clearance is the first step toward a test being CLIA Waived. Once a test is submitted to the FDA for clearance, they will assign the test a complexity rating. Often times tests will first be approved with a “high” or “medium” complexity rating, and manufacturers can address specific concerns and apply after-the-fact for a preferred complexity rating. In our “space” (instant drug testing), most commonly tests clear the FDA a “waived” complexity rating; mainly as we rarely see any great technological or methodology breakthroughs.

Why does this matter? As you may have noticed, my explanation included the term “medical”, and this is because the threshold for the CMS and FDA applying, would be if the testing is for medical purposes. Addiction medicine is an excellent example of this. As per CLIA regulations (short-form guidance can be found here and here), any facility that performs testing for medical purposes is considered to be a “laboratory”, and would be required to obtain a CLIA Certificate of Waiver, and further would be required to use only tests with a complexity rating of “waived”.

What about a test that has not yet been cleared by the FDA? Test devices and procedures that have not yet been cleared are given the designation of FUO (remember, Forensic Use Only). These tests should only be used by facilities who are testing for reasons that are not medical; criminal justice (drug courts, probation, etc.) is a perfect example of this as the testing is not being used to make diagnostic decisions, but typically only to determine compliance to a program’s requirements.

The good news is that, as it relates to instant drug testing, there is virtually no difference between a waived test and an FUO test, aside from some of the language contained in the instructions/ product insert. As an example, instructions on an FUO test may advise to “read the results in 5-10 minutes”, whereas the CLIA Waived version would say “read at 5 minutes”. Again, removing any room for error that misinterpreting the results might cause.

As always, please reach out to our team for any additional information or guidance.

If you read the instructions that are included in each box of tests (stop laughing, some people have!) then you have seen the recommendation that “positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance”. Every instant test does have built-in procedural controls; “a colored line appearing in the control area confirms specimen volume, adequate wicking, and correct procedural technique”. So, while the built-in controls indicate the test was performed correctly, it does not indicate performance (read accuracy and precision).

So, what are these external controls that the instructions recommend running? In short, they are synthetic urine specimens that are spiked with known and measurable concentrations of target substances, which should consistently provide the same result. For example, an external control to test the Benzodiazepine panel would contain at least 300ng/mL of Oxazepam, which is the calibrator – or target substance – that the BZO panel would react to. Since the instant tests’ accuracy becomes higher the further above cut-off we go, we typically recommend a “+50%” control. With our Benzo example, this means the controls would contain 450ng/mL of Oxazepam.

Since these are simply urine specimens, the controls are run just as you would run any other instant test. You would have one test that you would use the positive controls on – success would be that all the substances that are included positive control would cause a positive result on the corresponding panel on the instant test. You would also run a negative control, with success being none of the panels showing a positive result. We usually provide these controls in 5mL vials, with each vial containing enough specimen to run one test.

Now, of course not everybody pays attention to the instructions, or to the manufacturers’ recommendations. However, depending on the nature of your testing program, this can become more important to heed. This mainly affects healthcare facilities because they fall under the purview of CLIA (Clinical Laboratory Improvement Amendments), which requires that they follow all the manufacturers’ recommendations for using instant tests; they need to run quality controls once per shipment or once per lot, whichever comes first. Some healthcare credentialing bodies go even further than that, requiring that controls also be run once for every thirty days in storage, and once for every new hire.

Overall, it is excellent practice to run the controls per the manufacturers’ recommendations, and it is a quick and easy process, as there is very little difference in the procedure. Also, the cost for the controls is not considered prohibitive for most programs. For more information on this, or if you need to order controls, please reach out to your consultant.