InstaStrip Fentanyl Rapid Test (FDA cleared, Over-the-counter)

Order through Avantor/VWR: Box of 25

Product Overview

The FDA cleared InstaStrip Fentanyl Rapid Test (Urine) is intended for the qualitative detection of fentanyl in human urine at the cutoff value of 1.0 ng/mL. The test is intended for over-the-counter (OTC) use.

With FDA Breakthrough Device Designation, this device is developed utilizing competitive NIH research funding allocations and manufactured under strict FDA QMSR quality controls. Calibrated for exceptional precision, this assay minimizes false-negative outcomes within human urine, delivering clear qualitative visual results in 5 minutes to support clinical diagnostic protocols.

Technical Specifications & Key Data

This test is for over-the-counter (OTC) use, deployable in a wide variety of environments

• Target Matrix: Human urine specimens only.

• Analytical Cut-off Threshold: 1 ng/mL

• Assay Run Time: Qualitative visual results clear and readable within 5 minutes using naked eyes. No equipment requirement.

• Development & Quality Benchmarks: Product engineering and assay optimization backed by the National Institutes of Health (NIH). The device won designation for FDA Breakthrough Device.

• FDA Classification: Intend for over-the-counter (OTC) use.

Clinical & Public Health Significance

As synthetic opioids continue to dominate polysubstance patterns, rapid and accurate biological screening tools are critical for evaluating recent exposure timelines.

• Urinary Elimination Window: Fentanyl may be lethal at a very low concentration. A screening urine assay must have high sensitivity, typicallly 1 ng/mL.

• Cross-Reactivity Profile: This lateral flow matrix is engineered to minimize cross-reactive false positives from common over-the-counter analgesics, ensuring that positive screening lines truely correlate with true fentanyl exposure.

• Frontline Screening Efficiency: The dipstick format allows rapid screening in resource-limited settings without the immediate need for expensive automated laboratory instrumentation, serving as an ideal preliminary screen prior to confirmatory gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) analysis.

Ordering Options & Procurement Details

• SKU: ISTF24-C

• Packaging Configurations: Supplied in convenient boxes of 25 individually pouched dipsticks (each test strip is hermetically sealed with an active desiccant packet to guarantee a stable 24-month shelf life under standard room temperature storage).

• Institutional Supply Chains: Can be purchased directly from this website or through major laboratory distribution networks such as Avantor / VWR (link above Product Overview).

Frequently Asked Questions (FAQ)

• Q1: What is the exact analytical cut-off for the InstaStrip Fentanyl Rapid Test?

A: The technical limit of detection (LOD) is set at 1 ng/mL. This threshold is specifically calibrated to align with FDA required clinical diagnostic cutoff, ensuring high accuracy while reducing baseline background noise.

• Q2: What are the scientific, quality and regulatory credentials behind the InstaStrip Fentanyl Rapid Test?

A: The technology behind the device is an IP licensed from the University of Pennsylvania. The foundational assay development was supported by competitive funding from the National Institutes of Health (NIH). The device won FDA Breakthrough Device Designation, and was approved by FDA for over-the-counter (OTC) use.

• Q3: Can hospitals, clinical laboratories or public health agencies purchase this item through standard laboratory vendors?

A: Yes. The InstaStrip Fentanyl Rapid Test Box of 25 can be ordered through our verified product listings on primary distribution catalogs such as Avantor/VWR.

• Q4: Can these dipsticks be used for direct harm reduction street drug-checking?

A: No. This specific product is engineered, calibrated, and chemically optimized exclusively for a urine matrix. For direct testing of unknown powders, liquids, or pill residues, please utilize our standalone harm reduction field test strips instead, available under “Products for Harm Reduction and Forensics”.

Components For Each Kit

• Urine collection cup ×1
• Test tube ×1
• Test strip in sealed pouch x1
• Dropper ×1

Directions For Use

• Collect urine in the provided urine collection cup.
• Pull off the test tube cap, use the provided dropper to transfer 6 drops of urine (approximately 150 mL) to the test tube bottom, discard the dropper.
• Gently shake the test tube for 20 seconds, until the red pellet at the bottom disappears. Sample turns pink.
• Place the test tube on the tube stand in the box.
• Remove the test strip from the sealed pouch and insert into the test tube, arrows facing down. Recap the test tube.
• Start the timer for 5 minutes.
• At the end of 5 minutes, place the test tube against the result read chart to read your result. Do not interpret the result after 20 min.

This test provides only a preliminary result. A more specific alternative method must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is Gas or liquid chromatography/mass spectrometry is the preferred confirmatory method.

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InstaStrip Fentanyl Rapid Test (Urine) Package Insert

InstaStrip Fentanyl Rapid Test (Urine) Quick Instruction

FDA 510(k) Clearance