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.

We are frequently asked about the options for testing a powder or residue found on a participant, or at a facility for the presence of Fentanyl. In other words, if during a routine check of the property (residential, inpatient, correctional facility, etc.), a powder substance or residue is found, the staff may want to test to see if the powder that is found is or contains Fentanyl.

The obvious reason to test is safety, as nobody wants themselves nor their staff to be exposed to Fentanyl without proper safety precautions. Another reason is harm prevention/reduction; some facilities may have reason to test a user’s “stash” to determine if it might be contaminated by Fentanyl. This same could hold true for a better awareness of what substances might be common in their neighborhood.

If you find yourself in one of the above situations (or for any other reason that I may have neglected to include), we have good news: the instant test for Fentanyl, with the aid of a readily available and relatively inexpensive buffer solution, will detect Fentanyl itself. So, in addition to the more common use of testing urine for Fentanyl use, the Fentanyl instant test makes for an excellent and reliable forensic test as well. It makes the most sense to do this with the Fentanyl single-panel, as opposed to multi-panel dip or cup. Although, while it would certainly also work on the multi-panel, it typically makes the most send cost-wise (and ease of use) with the single-panel.

The other good news is regarding the cut-off level/drug concentration: our currently most popular single-panel Fentanyl dip is calibrated to Norfentanyl (the primary metabolite of Fentanyl) at 20 ng/mL (nanograms per milliliter) but will also detect the Fentanyl itself at 200 ng/mL. So, while you might be encountering a very small amount of powder, keep in mind that a nanogram is one billionth of a gram. We can imagine that a microgram (one millionth of a gram) is about the smallest amount of substance we could see with our “bare” eyes. Then two “grains” is already 1,000 times more Fentanyl than what is needed to trigger a positive on the test strip.

Lastly, it is incredibly simple to use, as seen in the instructions below:

If you would like additional information on this or need to order the buffer solution to begin testing in your facility, please reach out to myself or your consultant.

Fentanyl use continues to rise, and with increased usage comes increased data, and an increased understanding of the pharmacology of this extremely potent synthetic Opioid. In fact, chronic Fentanyl use is a relatively new phenomenon. I suspect that over time we will get an even clearer picture of what the long-term effects ofFentanyl use and misuse are.

If you had asked me a month ago how long Fentanyl is detectable in urine, I would have given my answer based on the common wisdom at the time: 4-5 days. However, around this time I learned some new information that has forever changed my answer to this question.

The situation was as follows: one of our clients looking at the lab results for one of her participants, asked me for clarification of what the results might mean. The result indication no presence of Fentanyl, but 76 ng/mL of Norfentanyl (the primary metabolite of Fentanyl) was confirmed present. My first thought was use in the preceding 4-5 days – as there was only the metabolite present, which we typically see near the outset of the window of detection. Discussing this further with our client, she indicated that this participant had been in jail for the 2 weeks prior to this specimen. We all know that it isn’t impossible to find drugs in jail, but she was confident this wasn’t the case in this situation. Luckily, while I like to brag about my 20 years’ experience and my boundless knowledge, I do have people I can turn to who have even more experience and an even deeper knowledge than I. My go-to toxicologist told me the story of a family member who had tested positive for Norfentanyl for weeks after last use. She apologized that she could not find any studies to back this up, and this was strictly anecdotal. After digging for a while, I too was unable to find any serious research to back this up. I was frustrated as I was not about to start sounding the alarm based solely on anecdotal evidence. So, I simply set the story aside for the time being.

Fast-forward about 3 weeks when I was discussing lab results with a different client. One of the lab results we looked at was a similarly high level of Norfentanyl confirmed, while Fentanyl was not present – almost an identical looking result to the one that started this. This led to a discussion about Quest Laboratories telling her they were investigating this same theory, and they were compiling Fentanyl confirmation result. More importantly, this led to a renewed (and more frenzied) search for some shred of clinical evidence that there was some truth to this (thanks Jennifer!).

I was finally able to find a reliable source of data in the form of this article from Boston University. It is by no means thorough enough to be the last word on this matter, but it was detailed enough for us to want to share this information with you. In summary, it explains that Fentanyl is lipophilic (which means dissolved in fat cells, as opposed to water), much like THC, and as such will build up over time with chronic use. This means that the window of detection for chronic Fentanyl users can be as long as 26 days or more.

 ***Disclaimer***

IMPORTANT UPDATE October 2021: It has come to our attention that the original study (linked in the Boston University article) used methodologies that are being called into question. So, while I was careful to include the disclaimer that this is “[not] the last word on this matter”, we feel it is important to note that this information should not be considered actionable and should be considered only theoretical until further studies can be performed, published, and reviewed. It is also our understanding that these further studies are in the works and look forward to providing a more substantiative update in the near future.

The first synthetic cannabinoid was synthesized in 1988; it was created by an organic chemist at Clemson University named John W. Huffman. He used his initials and designated this range of chemicals JWH-XXX (XXX representing the version numbers of his creations). There are nearly 400 active substances synthesized by Dr. Huffman (JWH-004 through JWH-425, with a few gaps for versions that were inactive or otherwise not optimal). We first started seeing evidence of these chemicals in illicit formulations in 2008, with JWH-018 & JWH-073 being the earliest; as mentioned above, the first retail products that we saw were K2 and Spice.

While there are a couple of synthetic cannabinoids that have an acceptable medical use, the vast majority of them are rightly considered dangerous drugs. Some of the effects (usually at lower doses) do mimic the effects of THC, but the side-effects are much more severe than THC and can include paranoia and psychosis. It is such an extreme substance that Dr. Huffman himself has said “It bothers me that people are so stupid as to use this stuff”.

As with the naming scheme, the drug testing industry also targeted these earliest versions of this burgeoning drug when determining which substances the test should detect. As such, the earliest tests were simply detecting the JWH-018 & JWH-073 (and their metabolites). As governments scrambled to enact laws against these substances, the manufacturers turned to other synthetic cannabinoids in their products to try and stay ahead of the law. Thus began the great “whack-a-mole” between manufacturers, law-makers, and drug test manufacturers trying to stay ahead of the changes. Currently our K2/Spice test detects 18 different substances. Unfortunately, not including the JWH compounds, there are 100+ synthetic cannabinoids that have been synthesized, but the test is constantly evolving. Recently we started seeing a synthetic cannabinoid hitting the streets that is a different structural classification (one of seven such classifications) – still part of the 100+ mentioned above. Substances in this classification, as well as the tests for them, are being colloquially referred to as K3. The K3 test detects another 14 substances. Currently the best solution for detecting synthetic cannabinoid use would be a “K2/K3 Combo” test; it is a test that has separate test areas for both classifications and provides a total of 32 substances detected.

Luckily, as of now, synthetic cannabinoid use is on the decline. Hopefully tighter enforcement and education will continue this trend. In the meantime, we will – as always – continue our progress in providing you a method of detecting these dangerous substances.