A Word on External Quality Controls

A Word on External Quality Controls

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.

Testing for the Presence of Fentanyl: Surfaces & Residues

Testing for the Presence of Fentanyl: Surfaces & Residues

 

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.

 

What We Know Now About the Window of Detection for Fentanyl

What We Know Now About the Window of Detection for Fentanyl

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.

 

 

 

 

A Closer Look into Synthetic Cannabinoids, Also Known As, K2/Spice

A Closer Look into Synthetic Cannabinoids, Also Known As, K2/Spice

One of the so-called “designer drugs” we talk about frequently is colloquially known as “K2/Spice”; named for the earliest products to became popular in the U.S. This colloquialism is why the drug testing industry decided to call our synthetic cannabinoid test a “K2/Spice Test”. More accurately, these substances are called “synthetic cannabinoids”. This designation is because the active chemicals bind to the same cannabinoid receptors in the human body that THC – the primary psychoactive component of marijuana – affects. In fact, this group of substances was synthesized in an attempt to find an alternative to marijuana. Interestingly enough, this research was funded by NIDA (National Institute on Drug Abuse).

 

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.

 

 

 

Oral Fluid Testing: The Rise in Demand Amidst a Pandemic

Oral Fluid Testing: The Rise in Demand Amidst a Pandemic

Safer Alternative

Since March, as businesses and government agencies started closing and investigating safer alternative ways of testing procedures, more and more people have been inquiring about oral fluids testing for drugs of abuse. These are sometimes referred to as saliva tests or mouth swabs. So, let’s talk a little bit about what they are, how they work, and why the sudden spike in interest.

There are a couple of reasons for the impression that oral fluids testing allows for a safer collection protocol. Firstly, an oral fluids drug test can be performed remotely via video conferencing software. The administrator can watch the donor collect the specimen themselves, watch the collected specimen being inserted into the test, and watch the results develop without the device or donor leaving the camera view. Secondly, an oral fluids test can be performed in an outdoor setting while maintaining social distancing guidelines. Of course, the donor must remove their face covering to collect the specimen, but you should still be able to witness the entire process at a safe distance.

 

How They Work & Procedures

If you are unfamiliar with oral fluids test, there are basically two parts: the collector, which is a sponge attached to a plastic handle and the test device itself, where the collector (sponge) is inserted to direct the specimen into the well inside of the test where the test strips are located. The collection process can be a little tricky until you get the hang of it – for starters, an uncooperative donor can purposefully withhold collecting enough saliva to allow the test to function – but once the procedure is mastered, the test is as easy to perform and read as a urine drug test. One other tricky step with collecting a specimen is that the test requires more saliva than you might think. The instructions only mention the amount of time it should take until you have enough specimen, but it is not that black and white. The donor should compress the sponge against their cheek or tongue and allow the decompression to absorb the excess fluid. In the worst-case scenario, they can also expectorate directly into the test device, or into an external receptacle, which can then be poured into the test.

 

Progress

Oral fluids tests have come a long way in the past 12-15 years. If you had asked back then, I would have discouraged their use or at least give warning about their accuracy and other shortcomings. Today, however, they are just as accurate as the urine drug tests that we provide. Additionally, the number of substances that can be tested has significantly caught up to the options we have for urine testing. Add to this the fact that it is impossible to adulterate an oral fluids test, if the instructions are followed properly, making them an excellent tool to have at your disposal.

 

Shortcomings & Final Word

Perhaps the only shortcoming of oral fluids testing, especially for most of your purposes, would be the window of detection. As the toxicology of urine closely mirrors the toxicology of blood, drugs are only detectable while they are still in the bloodstream, much like a breathalyzer only detecting current intoxication as opposed to an EtG test offering detection for up to 80 hours after use. So, the best-case scenario for oral fluids testing would be detection of less than 24 hours after use. In some situations, such as injury at work, where the important factor is detecting current intoxication, oral fluids testing makes the most sense. However, this window of detection isn’t always as useful to someone when the need to detect recent and past drug use requires a detection window that goes back days or even weeks in some cases.

In summary, oral fluids testing is a great option for programs looking to detect recent drug use. Though there are some drawbacks with their window of detection, they can be administered safely and frequently, while adhering to COVID-19 guidelines. If you would like any additional information on this, or any other subject, please leave a comment below or reach out to us directly. Stay safe and be well.

EDDP: The Methadone Metabolite

EDDP: The Methadone Metabolite

What is EDDP?

I often get asked about EDDP – primarily, “what is EDDP?”, and “should I care about EDDP?”. EDDP – the abbreviation for the chemical compound 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine – is a major metabolite of methadone. While methadone is not a widespread drug of abuse these days, it is certainly something you would not want to not test for. Hopefully, the information about EDDP in this blog post will help you decide if testing for EDDP would be beneficial.

As you may know, some drug tests are designed to react to the parent substance: in other words, the substance that was ingested, while some panels are designed to detect the metabolite: what the body changes that substance into as the body’s metabolism processes it into waste. As for substances, some are (at least partially) excreted in the exact same form that was ingested. For example, with methadone, in most cases, the body will excrete at least some methadone in the urine. Also, as with most substances, the body will excrete at least some amount of metabolite in the urine – in this case, we mean EDDP.

Should I Care About EDDP?

There are 3 primary reasons to care about, and test for, EDDP. Before we get there, it is important to note that there is a non-trivial percentage of people in the world who are “extensive metabolizers” of methadone; this means that while most people will excrete the parent compound in their urine, some will almost completely metabolize the methadone into EDDP. Since a standard methadone panel does not react to the EDDP, it gives us three risky scenarios: 1) You have a patient/participant using methadone illicitly and a simple methadone test is not detecting this. 2) You have a patient/participant who is supposed to be taking their methadone, but suspect they are instead spiking their specimen with methadone to give the illusion they are taking it, and 3) Same scenario as number two, except the patient/participant is taking their methadone as prescribed, yet is causing suspicion by producing a negative methadone test.

Another, lesser, benefit of testing EDDP, is that all methadone instant tests currently available will cross-react with Doxylamine – a substance found in the over-the-counter medications Nyquil and Unisom (amongst others). The EDDP panel has a much higher threshold for cross-reactivity for Doxylamine than the methadone panel.

So, EDDP may not necessarily be crucial to all programs, but it is good to know what it is, and if you should care about it. As always, please fell free to comment here or reach out to us should you have any questions or would like any additional information on the subject.