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Fentanyl Test Strip Product Improvement
Forensic and Law Enforcement Harm Reduction Drug Screening Updates Fentanyl Test Strip

Highlights:

  • The Rapid Response® Fentanyl Test Strip (2.0) is the only fentanyl test strip in the market that does not cross react with diphenhydramine, MDMA, and Methadone.
  • Microscoops now included with every test strip.
  • Guides, C and T labels are printed on the test strip for clear indication of interpreting test results Control and Test lines.
  • A QR code is printed on the back of every test strip pouch for access to resources and tutorial videos.
Introduction

Fentanyl is a highly potent, synthetic opioid related to the phenylpiperidines.1, 5 Fentanyl is approximately 100 times more potent than morphine and 50 times more potent than heroin.2 Fentanyl is commonly prescribed for moderate to severe pain relief.3 After continuous injection of fentanyl, the user may experience protracted opioid abstinence syndrome, such as ataxia and irritability, leading to addiction.6, 7

 

Due to the potency of fentanyl, fentanyl poses an extremely high overdose risk especially when used with other drug substances.4 Serious adverse effects of fentanyl can lead to opioid use disorder.1 As of 2018, fentanyl and its analogs are responsible for the majority of drug overdose deaths in the United States.6, 7

 

The presence of fentanyl and its use in unregulated settings pose significant concerns due to the drug’s high potency, as even small amounts of fentanyl can cause an overdose. The CDC has reported an increasing trend of opioid-related overdoses correlating to the rise of fentanyl and fentanyl-related analogues in the illicit drug supply. Fentanyl is currently listed as a Schedule II narcotic, while fentanyl-related analogues are currently listed as Schedule I narcotics by the US DEA.

 

Several modifications have been applied to the chemical structure of fentanyl, namely to the carbonyl group and benzene rings, resulting in a series of fentanyl analogues. Many of these analogues have similar potencies to fentanyl, however, in some cases, the modifications result in compounds with significantly heightened potency (e.g., carfentanil).

The Rapid Response® Fentanyl Test Strip from BTNX is specifically designed for the swift screening of fentanyl and fentanyl analogues in liquid/powder samples. The test incorporates an antibody that selectively identifies fentanyl and fentanyl analogues from other substances. Like other harm reduction test strips, it operates on a competitive binding principle and generates a colorimetric result. If any of the listed fentanyl substances are present in the sample at a concentration surpassing the designated cut-off, a singular-colored line will appear in the test. 

Results Interpretation

Positive – Fentanyl Detected: Only one colored line appears in the control region (C). No apparent colored line appears in the test region (T).

Negative – Fentanyl Could Not be Detected: Two colored lines appear on the membrane. One line appears in the control region (C) and another line appears in the test region (T).

Invalid: Control line fails to appear.

Please refer to the product insert for more details.

Test Performance - What has been improved?

BTNX is committed to maintaining a high level of efficacy and consistency with all its products. Since the beginning of 2023, additional efforts have been made to ensure the original Rapid Response® Fentanyl Test Strip continues to perform to its specifications, allowing users to be confident in the results they obtain. Building on this foundation, the Rapid Response® Fentanyl 2.0 Test Strip uses the latest improvements in lateral flow testing to consistently maintain the same level of detection for fentanyl and its analogues while decreasing the cross reactivity with non-fentanyl related compounds.

Analytical Sensitivity Comparison

The following compounds were spiked into water, respectively, to compare the Rapid Response® Fentanyl Test Strip (FYL 1.0 Test Strip) and the Rapid Response® Fentanyl 2.0 Test Strip (FYL 2.0 Test Strip) for detecting fentanyl and fentanyl-related analogues. The cut-off listed in the table represents the substance concentration at which the test strip will begin to show a mix of positive and negative results.

Fentanyl and fentanyl analogues that are detected below 100 μg/mL 
Compounds FYL 1.0 Test Strip FYL 2.0 Test Strip
Fentanyl  200 ng/mL  200 ng/mL 
Acetyl Fentanyl  150 ng/mL  150 ng/mL 
Butyryl Fentanyl  700 ng/mL  700 ng/mL 
Carfentanil  5000 ng/mL 5000 ng/mL
p-Fluoro Fentanyl  200 ng/mL  500 ng/mL 
Furanyl Fentanyl  500 ng/mL  500 ng/mL 
Ocfentanil  250 ng/ml  500 ng/mL 
Valeryl Fentanyl  700 ng/ml  1000 ng/mL 

 

The sensitivity of the Fentanyl 2.0 test strip is comparable to that of the Fentanyl 1.0 test strip. The key improvement in the Fentanyl 2.0 lies in its enhanced specificity.

Analytical Specificity

The following compounds were spiked into water to examine possible cross-reactivity for the two versions of the FYL test strips. Significant improvements were found for most of the compounds with the FYL 2.0 Test Strip. Most fentanyl strips on the market cross-react with diphenhydramine, which is a very common cutting agent.8 FYL 2.0 is the first fentanyl test strip designed to address this issue.

Compound Concentration FYL 1.0 FYL 2.0
Methamphetamine  5 mg/mL Negative Negative
MDMA 5 mg/mL False Positive Negative
Diphenhydramine 5 mg/mL False Positive Negative
Lidocaine 5 mg/mL False Positive Negative
Levamisole 5 mg/mL Negative Negative
Methadone 5 mg/mL False Positive Negative
Heroin 3 mg/mL Negative Negative
Morphine 5 mg/mL Negative Negative
Codeine 5 mg/mL False Positive Negative
Quinine 5 mg/mL Negative Negative

 

Packaging - What's new?

To help guide users in reading their test results more easily we’ve updated our test strip to add C and T marks on the strip to clearly indicate the side of the strip membrane where the Control line and the Test line will appear.

With each test strip kit, we’ve added microscoops as a new tool to enhance harm reduction testing processes. While instructions include measurement guidelines, we recognized that some users may not have access to the tools needed for precise sample measurement. The microscroops are designed to simplify the testing process and are intended for more accurate drug screening with our products.

Ordering Information

Rapid Response® Fentanyl 2.0 Test Strip is now available to purchase as Rapid Response® Fentanyl Test Strip (Liquid / Powder) under the product code FYL-18S7-100 from Lochness Medical Supplies in the USA and BTNX Inc. in Canada and the international market.

Buy now: Canada, USA

References
  1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd ed. Davis: Biomedical Publications; 1982.
  2. NIDA. Fentanyl DrugFacts. National Institute on Drug Abuse website. http://nida.nih.gov/publications/drugfacts/fentanyl. June 1, 2021 Accessed April 5, 2023.
  3. Gilman AG, Goodman LS, Gilman A, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan; 1980.
  4. NIDA. Drug Overdose Death Rates. National Institute on Drug Abuse website. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. February 9, 2023 Accessed April 5, 2023.
  5. International Narcotics Control Board. Report of the International Narcotics Control Board for 2009[R].New York:UN, 2010
  6. Lane JC, Tennison MB, Lawless ST, et al. Movement disorder after withdrawal of fentanyl infusion. J Pediatr, 1991, 119(4):649-651
  7. Dominguez KD, Lomako DM, Katz RW, et al. Opioid withdraw in critically ill neonates. Ann Pharmacotherm, 2003, 37(4):473-477
  8. Lieberman, M. (n.d.). FTS lot characteristics public facing draft. Google Docs. https://tinyurl.com/LotResults