THE EPIDEMIC ENDER

When U.S. federal agencies (especially the Drug Enforcement Administration and Centers for Disease Control and Prevention) describe the current “most dangerous” or “highest-threat” drugs in the illicit supply, they usually refer to a group of extremely potent synthetic opioids and sedative adulterants driving overdose deaths.

Based on DEA threat assessments and CDC surveillance, the six substances most frequently identified as the deadliest threats in the current U.S. drug supply are:

• The primary driver of overdose deaths in the United States.
• Just 2 mg can be fatal in many cases. (DEA)

• An extremely powerful fentanyl analog originally used to sedate elephants.
• A microscopic amount can cause death in humans. (DEA)

• A class of synthetic opioids even more potent than fentanyl in some cases.
• Increasingly appearing in the illicit supply and linked to fatal overdoses. (PMC)

• A veterinary sedative mixed with fentanyl to prolong the high.
• Not an opioid, so naloxone does not reverse its effects, complicating overdoses. (CDC)

• A newer animal tranquilizer similar to xylazine but more potent.
• Emerging in U.S. drug markets and causing overdose clusters. (CDC)

• Often mixed with opioids to increase sedation.
• Greatly increases fatal overdose risk when combined with fentanyl or heroin. (CDC)

✅ Key point from federal reports:
The deadliest threat today is polysubstance poisoning—especially fentanyl combined with sedatives like xylazine, medetomidine, or benzodiazepines—which makes overdoses harder to reverse and more likely to be fatal. (CDC)

✔️ In short, the six drugs most commonly identified by U.S. authorities as the deadliest are finally all detectable on one single test strip.

Cutoff Levels: 

Fentanyl - 1ng/mL

Carfentanil - 20ng/mL

Xylazine - 25ng/mL

Nitazenes - 50ng/mL

Benzos - 20ng/mL

Medetomidine - 100ng/mL

Dilution Required? NO - 100% preservation of the tested substance

These strips can be used on any surface or substance (including gels, pastes, liquids, powders, crushed pills, clothing, and human hair) to determine if Fentanyl, Carfentanil, Xylazine, Nitazenes, Medetomidine, or Benzos are present.  The Harm Reduction test can be used on any surface, such as a couch, bed, car, countertop, etc. These tests are often used by first responders and emergency room clinicians in victims' nasal passages, saliva, or visible injection wounds sites to detect drug residue to know immediately what someone is poisoned by giving the best chance at revival and survival. 

The Fentanyl Test is proud to bring a newly FDA-cleared line of Fentanyl tests and life-saving innovation in the effort to help solves the struggles of the Fentanyl epidemic.

Intended use

The 4-panel Harm Reduction is a one-step lateral flow immunoassay device for the detection of drug residues on suspected surface or in powder. The Harm Reduction device detects Fentanyl at the cutoff of 1 ng/ml, Carfential 20ng/mL, Xylazine at 25ng/mL, Nitazenes 50ng/mL, Medetomidine at 100ng/mL, and Benzodiazepines at 20ng/mL.

This product is intended for forensic use only and is not for use in diagnostic procedures.

The Harm Reduction provides only preliminary drug test results. For a quantitative result or for a confirmation of a presumptive positive result obtained by the Harm Reduction, a more specific alternative method such as GC/MS or LC/MS must be used.

Summary and Explanation

Illegal drug consumption contributes to many accidents, injuries and medical conditions. The Harm Reduction is developed to detect drug residues on suspected surface or in powder. It is designed to integrate the collection of sample and lateral flow immunoassay screen testing in one single device.

Test principle

The Harm Reduction is based on a competitive immunoassay procedure in which drug derivatives immobilized on the membrane compete with the drug(s) which may be present for limited antibody binding sites on the colored colloidal gold antibody conjugate. During testing, drug residue is collected by the collection pad, and migrates across the membrane when buffer is added. If no drug is present on the surface, the colored colloidal gold antibody conjugate will bind to the drug derivatives on the membrane to form visible bands at specific test regions. Therefore, the presence of a purple-red band at a specific test region indicates a negative result. 

If any drug(s) is (are) present on the surface, it competes with the immobilized drug conjugate for limited antibody binding sites of the colored colloidal gold conjugate. When sufficient amount of drug is present, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug derivative on the membrane. Therefore, the absence of a purple-red band at the test region indicates a presumptive positive result for that particular test.

A control band at the control region (C) indicates the test has performed properly. This control band should always appear regardless of the presence of drug or metabolite.

Reagents

The Harm Reduction contains one membrane strip and a collection pad. The strip consists of a membrane immobilized with drug-protein conjugates and corresponding specific drug monoclonal antibody colloidal gold conjugate pad, a sample pad and an absorbent pad.

Collection Pad: The collection pad consists of an absorbent material.

Buffer: The buffer dissolves and/or extracts the drug from suspected residues.

Materials Provided

Each Harm Reduction kit contains:

1 Package Insert.

1 Test Strip (individually packaged in a foil pouch with a desiccant).

1 Buffer Vial ( 0.15 ml per vial)

Warnings and Precautions

• The Harm Reduction is intended for Forensic Use Only.
• The test device should remain in its original sealed pouch until ready for use.
• Discard the test device if package is ripped or torn.
• Do not use the test device beyond the expiration date indicated on the kit.

Product Storage

The Harm Reduction pouch should be stored at room temperature (15°-30°C). Do not open pouch until ready to perform the assay.

Test Procedure

1. Open the device kit and remove the test strip from the sealed pouch.
2. Swipe small amount of powder or suspected surface with the sample pad of test strip below arrow, then add 3 drops of buffer onto collection pad until fluid show up in the window area. For liquids, dip the sample pad of the test strip in the substance liquid, then add one drop of buffer to sample pad on a flat surface.
3. Lay the device on a flat surface and read results in approximately 5 minutes. Do not read results after 10 minutes.