This article was first published on February 25, 2024. It was last reviewed, updated, or edited on February 26, 2024.
Fentanyl is a very potent synthetic opioid that has led to a public health crisis in the United States because (National Institute on Drug Abuse):
– Synthetic opioids other than methadone (mainly fentanyl) are the leading cause of drug overdose deaths in the United States.
– Drug overdose deaths have increased by more than 700% in recent years.
– In the US, synthetic opioids other than methadone (mainly fentanyl) lead to more deaths than death by suicide.
Given the seriousness of the fentanyl epidemic and the huge number of people who are dying each year due to it, all articles on this website about fentanyl and fentanyl analogs are being made available to everyone and not only to our Members (subscribers). For links to the articles on this website about fentanyl, fentanyl analogs, and fentanyl opioid use disorder (addiction), please see Related Pages below. Please share these articles widely by email, social media, and other means.
Standard urine drug screens will not detect fentanyl. This applies to both testing in a laboratory and in clinical settings. For more on this, please see the following article on this website:
Special tests are needed to identify fentanyl in the urine
FDA-cleared over-the-counter fentanyl urine test
In October 2023, the United States Food and Drug Administration or FDA “cleared” the first urine test to screen for the presence of fentanyl that is available without a prescription (“over-the-counter”)— Alltest Fentanyl Urine Test Cassette, manufactured by Hangzhou AllTest Biotech Co, Ltd, a Chinese company (website). Previously, this test was available by prescription only.
See the image below. In case you are wondering, “FYL” is an abbreviation for fentanyl.
Note: This particular test is very sensitive and detects fentanyl if present at a concentration of 1 ng/mL or more. Many other fentanyl urine tests are available, including those from the same manufacturer, that detect fentanyl only if it is present in a higher concentration. It is important to not buy one of those by mistake.
If positive, confirmatory testing must be done
It is crucial to realize that the Alltest Fentanyl Urine Test Cassette, which is based on immunoassay, is a screening test.
As with all immunoassay screening tests:
– If the result is negative, we can be fairly confident that fentanyl was not present in the urine.
– But, if the result is positive, confirmatory testing must be done.
Packaging, availability, and cost
The Alltest Fentanyl Urine Test Cassette is available in a one-pack but is much more economical in a 25-pack that contains:
– 25 individually wrapped fentanyl test cassettes
– 25 pipette droppers
The 25-pack is available online at Amazon.com (link) and Walmart.com (link) for $62.50, that is, $2.50 per test.
How to use the Alltest Fentanyl Urine Test Cassette
Note: A cup to collect urine is not included in the product.
User instructions are available at this link.
1. Open the foil pouch and take out the test cassette and dropper,
2. Put the test cassette on a level surface.
3. Using the provided dropper, draw up urine from the cup in which it was collected.
4. Squeeze 3 full drops of urine into the specimen well (next to the letter “S” ) on the test cassette. See the image below. Be careful to not spill any urine into the test window itself.
5. Immediately after putting in the urine, start a timer for 5 minutes.
6. When the 5-minute timer goes off, read and interpret the results as shown in the image below. (If there is a delay in reading the results, do NOT read the results if more than 10 minutes have elapsed.)
Note:
– C denotes control. The control line should always appear, whether or not the urine is positive for fentanyl. If it doesn’t, something went wrong with the test and the results are invalid.
– T denotes Test. It is counter-intuitive but if a line appears next to the T, the test is Negative.
– In the image below, under Negative and Invalid results, two possibilities are shown; both of them would be interpreted in the same way.
If dilution or adulteration of the urine is suspected…
The Alltest Fentanyl Urine Test Cassette result may be false negative (that is, negative for fentanyl even though fentanyl is present in the urine) if the urine was deliberately diluted or adulterated by adding bleach or alum.
If this is suspected, the test should be repeated on a sample obtained by observed collection of urine.
If the test shows a positive result…
It is extremely important for us to remember that the Alltest Fentanyl Urine Test Cassette is only a screening test. If it shows a positive result for fentanyl, confirmatory testing MUST be done before concluding that this is the case because false positives can occur. See below for how to do confirmatory testing
A false positive result can occur with the following:
Psychiatric medications (Kerensky et al., 2021)
Amitriptyline
Fluoxetine
Haloperidol
Risperidone (Three cases reported by Shroitman et al., 2021; five cases reported by Wang et al., 2014).
Trazodone
Ziprasidone (case report by Waters and Tewksbury, 2022).
Non-psychiatric medications (Kerensky et al., 2021)
Labetalol (Three cases reported by Wanar et al., 2022).
Other illicit substances
Methamphetamine (Abbott et al., 2022; Lockwood et al., 2021)
MDMA (Lockwood et al., 2021)
Diphenhydramine (used commonly to “cut” heroin; Lockwood et al., 2021)
Some foods and food supplements
How to do confirmatory testing
For those persons who screen positive using the Alltest Fentanyl Urine Test Cassette, we need to send a urine sample out for confirmatory testing.
Option no. 1: Use the pre-addressed mailing box that is included with the product to mail a urine sample to the manufacturer for confirmatory testing. Important! The cost of shipping and the confirmatory test are NOT included in the cost of the Alltest Fentanyl Urine Test Cassette.
Option no. 2: Alternatively, we can send the person or a urine sample to any laboratory (for example, Labcorp® or Quest Diagnostics®) for a confirmatory test.
Related Pages
Fentanyl
Why we MUST know about fentanyl and fentanyl analogs
Special tests are needed to identify fentanyl in the urine
Special issues in using naloxone to treat overdose involving fentanyl or a fentanyl analog
An overview of fentanyl opioid use disorder (addiction)
Special points in the management of fentanyl opioid use disorder (addiction)
Fentanyl analogs and why they are so important
Why and how to use fentanyl test strips
Urine drug screening
Which urine drug screen (UDS) should we specifically order?
Which urine drug screen do most workplaces require?
False-positive urine drug screen: Principles and a table for reference
Opioids in the urine drug screen
Special tests are needed to identify fentanyl in the urine
Standard urine drug screens can be false-negative for some benzodiazepines
Will zolpidem be detected on a standard urine drug screen?
For how long are substances detected in a urine drug screen (UDS)?
“Fingerprint” metabolites that uniquely identify substances in a urine drug screen
References
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