FDA Clears First OTC Test for Preliminary Detection of Fentanyl in Urine

Fentanyl Urine Test

The FDA recently cleared the first over-the-counter test for the preliminary detection of fentanyl in urine, marking a significant step in substance misuse surveillance. This test operates by applying three drops of fresh urine onto a cassette that houses a fentanyl test strip. Within five minutes, the presence of fentanyl is indicated by the appearance of colored lines on the strip.

This development arrives amidst a pressing need to combat the rampant abuse of fentanyl, a drug notorious for its role in a multitude of fatal and non-fatal overdoses worldwide. The availability of such a test is particularly crucial in the United States, where the misuse of fentanyl, including products like transdermal patches and lozenges originally intended for cancer pain management, has contributed significantly to the overdose epidemic.

Let us take a look at the newly approved over-the-counter test for the qualitative determination of fentanyl in urine samples.  

Drug abuse as a major biological issue in today’s world
Drug abuse as a major biological issue in today’s world

What is Fentanyl?

Fentanyl is a drug of synthetic origin that falls in the category of opioids. It has been used as a narcotic analgesic for the treatment of severe pain often associated with cancer and is usually manufactured in the form of lozenges or transdermal patches.

According to the Centers for Disease Control and Prevention (CDC), the potency of fentanyl exceeds that of morphine by a percentage of 50 to 100. It has also been reported to have 50 times higher potency than diamorphine or heroin. 

Statistics Regarding Fentanyl Abuse in the US

In the years 2020 to 2021, a 22% increase has been reported in the deaths caused by the overdose of opioids which are inclusive to those caused by fentanyl as well as its analogs. This mortality rate, according to the CDC, accounts for 71,000 deaths on an annual basis in the US alone.

As the drug also has a high potential for abuse, the chances of addiction are extremely high despite its short-lived ecstatic effects. Unconditional access to healthcare facilities is the only way to lessen this damage.

ALLTEST Fentanyl in Urine Test Cassette

On October 27th, 2023, the Food and Drug Administration (FDA) gave approval to the ALLTEST fentanyl urine test owing to its significance in rapidly detecting fentanyl in urine samples. The test is for prescription use only and can detect concentrations as small as 1.0 ng/ml. With a sensitivity of 98%, the in vitro diagnostic fentanyl in urine test is thus reliable and easy to conduct.

Testing strips for the fentanyl urine test
Testing strips for the fentanyl urine test

Mechanism of Fentanyl in Urine Test

The chemistry behind the fentanyl in urine test involves an antigen-antibody immunochemical reaction. If the urine sample contains free fentanyl or its conjugates, the antibodies tend to bind these components thus indicating a positive result.

How to Perform ALLTEST Fentanyl Urine Test?

The procedure to conduct the rapid fentanyl in urine test is very quick and yields the results within a few minutes. To conduct this test, the following procedure is recommended:

– A fresh urine specimen is obtained from the patient for the qualitative determination of fentanyl.

– From it, three drops are extracted and transferred onto the cassette which contains a fentanyl test strip.

– The strip is then kept still on a flat surface for 5 minutes or until the results appear.

Interpretation of the Test Results

The results of the ALLTEST fentanyl urine test are indicated in the form of colored lines. The appearance of a colored line manifests a negative result while an absence of a colored band on the test zone means a positive result. A control band is also present on the test strip for comparison.

    ALLTEST Fentanyl Urine Test  The colored band on the test zoneInference
PresentNegative test result
AbsentPositive test result

A chance of a false positive test exists when the urine sample has been contaminated with chemical agents such as bleach. Moreover, certain food products as well as supplements can also alter the test findings.

To further confirm the findings of the preliminary fentanyl in urine test, the patient can also be subjected to more accurate chemical tests. For this purpose, the Substance Abuse Mental Health Services Administration (SAMHSA) recommends conducting gas chromatography/mass spectrometry (GC/MS).

Intentional overdose of drugs leads to abuse
Intentional overdose of drugs leads to abuse

The fentanyl rapid test cassettes mentioned in this article, along with multiple other medical supplies, are available at Health Supply 770 at the most affordable prices. Furthermore, the prices are even lower during the weekly deals they offer on certain items. Do check them out for stocking up on some essential medical supplies.

Limitations of ALLTEST Fentanyl Urine Test

Despite its vast utility and ease of conduction, the ALLTEST fentanyl in urine test has certain limitations as well which include the following:

– The rapid urine test does not quantify the amount of drug present in the urine sample. It is only restricted to the identification and detection of fentanyl and its analogs.

– The ALLTEST fentanyl urine test strips can indicate false results in the presence of certain contaminants thus hampering their reliability.

– Improper storage of test strips i.e. at a temperature exceeding the recommended range of 39 to 86°F, can also lead to a false negative result.

– ALLTEST fentanyl urine test is a preliminary test that can give an initial indication of the presence of fentanyl. The employment of more reliable tests is required to further confirm the obtained results. 


Drug abuse is one of the major challenges faced by the developed world today. In this regard, the number of deaths occurring on an annual basis is consistently increasing. Among the drugs that have the potential for abuse, fentanyl, along with its analogs, has been overdosed and is frequently named.

The FDA has recently approved ALLTEST fentanyl test cassettes for the qualitative determination of fentanyl in urine samples. Being highly sensitive and cost-efficient, the testing method is preferred as a preliminary approach to detecting the drug.

These test strips are easy to use and give quick results. Purchasing medical supplies from a reliable vendor like Health Supply 770 ensures the provision of good quality products with satisfactory services.



Uzma Zafar

Uzma Zafar is a dedicated and highly motivated pharmaceutical professional currently pursuing her PhD in Pharmaceutics at the Punjab University College of Pharmacy, University of the Punjab. With a comprehensive academic and research background, Uzma has consistently excelled in her studies, securing first division throughout her educational journey.

Uzma’s passion for the pharmaceutical field is evident from her active engagement during her Doctor of Pharmacy (Pharm.D) program, where she not only mastered industrial techniques and clinical case studies but also delved into marketing strategies and management skills.

Throughout her career, Uzma has actively contributed to the pharmaceutical sciences, with specific research on suspension formulation and Hepatitis C risk factors and side effects. Additionally, Uzma has lent her expertise to review and fact-check articles for the Health Supply 770 blog, ensuring the accuracy and reliability of the information presented.

As she continues her PhD, expected to complete in 2025, Uzma is eager to contribute further to the field by combining her deep knowledge of pharmaceutics with real-world applications to meet global professional standards and challenges.