Healgen Scientific is proud to announce that the Healgen® AccuFluor™ Fentanyl Fluorescence Immunoassay (FIA) Test Kit has received CLIA categorization waived status. This kit must be used with the Healgen® Immunofluorescence Analyzer OG-H180-CW. This milestone expands access to a fast and convenient fentanyl screening solution, designed to support testing in waived settings and point-of-care workflows.
A Growing Public Health Challenge
Fentanyl remains a major driver of overdose risk, in part because illicit fentanyl is often present in counterfeit or adulterated street drugs without the user’s knowledge. That reality has made rapid screening more crucial than ever for critical care settings such as emergency departments, ambulances, intensive care units, treatment settings, law enforcement, and community organizations that support timely intervention. As demand grows for accessible testing, tools are needed to help identify potential exposure quickly and reliably.
A Practical Testing Solution
The Healgen® AccuFluor™ Fentanyl FIA Test Kit is a qualitative fluorescence immunoassay intended for the detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The system is designed for use with the Healgen® Immunofluorescence Analyzer OG-H180-CW and is now waived under CLIA. Together, the test kit and analyzer provide a streamlined workflow that supports high precision and reproducibility, especially near cut-off, by removing user interpretation through an instrument read assay.
Designed for Ease of Use
Healgen’s fentanyl testing system is built with simplicity in mind, helping users follow a clear step-by-step process with Quick Reference Instructions and Instructions For Use. The analyzer is a portable fluorescence instrument for in vitro diagnostic use to deliver a qualitative result. External quality control material, as well as a built-in procedural control on each strip, ensures proper test performance.
Supporting Timely Clinical Decisions
Because fentanyl screening results are preliminary, positive findings should be confirmed using a more specific method such as GC-MS/MS or LC-MS/MS. Even so, rapid screening can play an important role in guiding next steps, helping frontline workers act quickly to support better outcomes. In an environment where speed and reliability matter, having a CLIA-waived option can expand testing capacity without adding unnecessary complexity.
Healgen’s Commitment
This CLIA waiver reflects Healgen’s ongoing commitment to developing simple, practical test solutions for urgent public health needs. By combining a focused assay, a user-friendly analyzer, and clear instructions, Healgen aims to help staff in multiple settings effectively respond to the fentanyl crisis.
Learn More About Healgen
Explore the Healgen website to learn more about rapid tests and discover additional testing solutions: https://www.healgen.com/human-health