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Specification |
Details |
|
Drug Detected |
Fentanyl |
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Technology |
Fluorescence Immunoassay (FIA) |
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Cutoff Level |
1 ng/mL |
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Sample Type |
Human Urine |
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Sample Required |
3 Drops of Urine |
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Time to Results |
Approximately 5 Minutes |
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Analyzer Required |
Serenity FentaScan™ Analyzer |
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Regulatory Status |
FDA Approved & CLIA Waived |
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Intended Use |
Professional Point-of-Care Screening |
Using the FentaScan™ Fentanyl Cartridge is simple:
Collect a fresh urine specimen.
Remove the cartridge from its protective pouch.
Place the cartridge on a clean, flat surface.
Add 3 drops of urine into the sample well.
Insert the cartridge into the FentaScan™ Analyzer immediately (Standard Mode) or after manual incubation (Quick Mode).
Start the test using the analyzer.
The analyzer automatically processes the sample.
Read the digital result in approximately 5 minutes.
The analyzer provides automated interpretation, helping improve workflow efficiency and reducing operator variability
Fentanyl is a powerful synthetic opioid prescribed for the treatment of severe pain, including cancer-related pain, post-operative pain, and chronic pain requiring continuous opioid therapy. Because fentanyl is significantly more potent than many other opioids, it must be administered under strict medical supervision.
In recent years, fentanyl has become increasingly prevalent in illicit drug markets, making rapid and accurate fentanyl screening an essential component of professional drug testing, emergency medicine, addiction treatment, and forensic investigations.
Unlike traditional rapid drug tests that rely on visual interpretation of colored lines, the FentaScan™ System uses Fluorescence Immunoassay (FIA) technology for automated digital analysis.
The analyzer detects fluorescent signals generated during the test and automatically determines whether the sample is positive or negative according to the established cutoff level.
This technology offers several advantages:
Automated digital interpretation
Improved analytical sensitivity
Reduced operator variability
Consistent and objective results
Fast processing time
Professional point-of-care performance
The Fentanyl Cartridge features an ultra-sensitive cutoff level of 1 ng/mL, allowing detection of very low concentrations of fentanyl in urine.
The FentaScan™ Analyzer offers two flexible operating modes to accommodate different clinical workflows.
After adding three drops of urine to the cartridge, insert the cartridge directly into the analyzer. The instrument automatically incubates, processes, and interprets the test, displaying results in approximately 5 minutes.
The sample may first be incubated outside the analyzer before inserting the cartridge for automated reading. This option provides additional workflow flexibility for busy testing environments.
Both modes deliver the same digital interpretation while allowing users to choose the procedure that best fits their operational requirements
Compared with visually interpreted rapid tests, the FentaScan™ System provides several important benefits:
Automated result interpretation
Eliminates subjective visual reading
Improved consistency between operators
Digital result display
High analytical sensitivity
Rapid processing in approximately 5 minutes
Supports secure electronic record management
Cloud-enabled data tracking (compatible systems
The Fentanyl Cartridge – FDA Approved & CLIA Waived combines advanced Fluorescence Immunoassay (FIA) technology with automated digital interpretation to provide fast, reliable fentanyl screening at the point of care. Its 1 ng/mL sensitivity, 5-minute turnaround time, and compatibility with the FentaScan™ Analyzer help improve testing accuracy while simplifying workflow.
With automated analysis, digital reporting, and cloud-enabled data management capabilities, the system is an excellent choice for healthcare facilities, clinical laboratories, workplace testing programs, rehabilitation centers, emergency departments, law enforcement agencies, and forensic laboratories requiring rapid and dependable fentanyl screening.
For best performance:
Store cartridges according to the manufacturer's recommended storage conditions.
Keep each cartridge sealed until ready for use.
Do not use cartridges beyond the expiration date.
Protect cartridges from excessive heat, humidity, and direct sunlight.
Use fresh urine specimens whenever possible.
Operate the FentaScan™ Analyzer according to the manufacturer's instructions
The Fentanyl Cartridge is intended to provide preliminary qualitative screening results only.
A positive result indicates the possible presence of Fentanyl at or above the screening cutoff but does not determine the amount used or the degree of impairment.
A negative result does not completely exclude fentanyl exposure if drug levels are below the cutoff concentration or outside the detection window.
Individual metabolism, specimen quality, medications, and testing procedures may influence results.
The analyzer improves consistency by eliminating subjective visual interpretation but does not replace confirmatory laboratory testing.
All preliminary positive results should be confirmed using GC-MS or LC-MS/MS before medical, legal, employment, or administrative decisions are made
The cartridge is designed to detect Fentanyl in human urine using advanced Fluorescence Immunoassay (FIA) technology.
The screening cutoff is:
Fentanyl: 1 ng/mL
This ultra-sensitive cutoff allows detection of very low concentrations of fentanyl
The FentaScan™ Analyzer provides automated digital results in approximately 5 minutes.
Yes. The cartridge is designed for use with the Serenity FentaScan™ Analyzer, which automatically processes the fluorescence signal and displays the result
Automated digital interpretation helps:
Eliminate subjective visual reading
Improve consistency between operators
Reduce interpretation errors
Deliver fast and standardized results
Improve workflow efficiency
No. This cartridge provides preliminary screening results only. Any preliminary positive result should be confirmed using GC-MS or LC-MS/MS before legal, medical, employment, or administrative decisions are made
The Fentanyl Cartridge is intended for:
Hospitals
Emergency departments
Clinical laboratories
Point-of-care testing facilities
Rehabilitation centers
Occupational health clinics
Workplace drug testing programs
Law enforcement agencies
Forensic laboratories
Professional healthcare providers
The Fentanyl Cartridge – FDA Approved & CLIA Waived combines advanced Fluorescence Immunoassay (FIA) technology with the Serenity FentaScan™ Analyzer to deliver fast, highly sensitive, and automated fentanyl screening at the point of care. Featuring an ultra-sensitive 1 ng/mL cutoff, digital result interpretation, and results in approximately 5 minutes, the system provides reliable preliminary screening while minimizing operator variability.
Designed for use in hospitals, emergency departments, clinical laboratories, rehabilitation centers, occupational health clinics, workplace testing programs, law enforcement agencies, and forensic laboratories, the FentaScan™ System offers an efficient and dependable solution for professional fentanyl screening. Its automated workflow, secure digital reporting capabilities, and FDA Approved, CLIA Waived status make it well suited for modern point-of-care testing environments.
As with all rapid immunoassay screening devices, any preliminary positive result should be confirmed using Gas Chromatography–Mass Spectrometry (GC-MS) or Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) before medical, legal, employment, or administrative decisions are made. The Fentanyl Cartridge is intended for professional point-of-care use only and should be operated in accordance with the manufacturer's instructions and applicable regulatory requirements.
The Fentanyl Cartridge is an FDA Approved and CLIA Waived fluorescence immunoassay (FIA) test designed for the rapid qualitative detection of Fentanyl in human urine. Used together with the Serenity FentaScan™ Analyzer, this advanced testing system delivers highly sensitive and reliable point-of-care screening with results available in approximately 5 minutes.
Unlike conventional visual rapid tests, the FentaScan™ system utilizes fluorescence immunoassay technology, allowing the analyzer to automatically interpret the test and eliminate subjective visual interpretation. The system is designed for healthcare professionals who require consistent, accurate, and efficient fentanyl screening.
Featuring an ultra-sensitive 1 ng/mL cutoff level, the Fentanyl Cartridge is capable of detecting very low concentrations of fentanyl in urine. Its automated analysis, combined with advanced fluorescence technology, supports accurate preliminary screening in hospitals, emergency departments, addiction treatment programs, occupational health clinics, and forensic laboratories.
Testing is simple and efficient. Only three drops of urine are required, after which the cartridge is inserted into the FentaScan™ Analyzer. The analyzer processes the sample automatically and displays clear digital results in approximately 5 minutes.
The FentaScan™ System also supports secure electronic result management and cloud-enabled data tracking, making it suitable for facilities that require streamlined documentation and workflow integration.
This product provides preliminary qualitative screening results only. Any preliminary positive result should be confirmed using Gas Chromatography–Mass Spectrometry (GC-MS) or Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) before medical, legal, employment, or administrative decisions are made.
Fentanyl: 1 ng/mL
Samples containing fentanyl at or above this concentration may generate a preliminary positive result and should be confirmed using an appropriate laboratory confirmation method
The screening cutoff is:
Fentanyl: 1 ng/mL
This ultra-sensitive cutoff allows detection of very low concentrations of fentanyl
The FentaScan™ Analyzer automatically reads the fluorescence signal and displays a digital test result, eliminating the need for manual interpretation
If the urine sample contains no detectable fentanyl or the fentanyl concentration is below the 1 ng/mL cutoff level, the analyzer will display a Negative result.
A negative result indicates that fentanyl was not detected at or above the screening cutoff. However, it does not completely rule out fentanyl use if drug levels are below the detection limit or outside the detection window
If the analyzer detects fentanyl at or above the 1 ng/mL cutoff level, it will display a Positive result.
A positive result indicates the possible presence of fentanyl in the urine sample and should be considered preliminary.
Because this device is a screening test, all preliminary positive results should be confirmed using a more specific laboratory method such as Gas Chromatography–Mass Spectrometry (GC-MS) or Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS) before medical, legal, employment, or administrative decisions are made
Each test includes an internal quality control system.
The Control (C) signal must be successfully detected by the analyzer to verify that:
If the quality control check fails, the analyzer will indicate an invalid test, and the sample should be retested using a new cartridge
Fentanyl Cartridge Urine Drug Test 1 ng/mL– FDA Approved & CLIA Waived | Serenity SM-FENTASCAN-CART 25/Box
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