Labcorp Launches First FDA-Cleared Rapid Fentanyl Test Made in US, Delivers Results in 10 Minutes
核心洞察
Labcorp (搜索) has launched the first FDA-cleared rapid fentanyl test manufactured in the United States, delivering results in just 10 minutes for emergency departments and hospitals.
The test detects norfentanyl (搜索), the primary fentanyl metabolite, providing up to 48 hours of detection window compared to fentanyl itself which clears within hours.
Labcorp (搜索) data reveals approximately 4% of pre-employment screenings and nearly 10% of opioid use disorder (搜索) treatment patients tested positive for fentanyl between 2024 and 2025.
Labcorp (搜索) has introduced the first FDA-cleared rapid fentanyl test manufactured in the United States, marking a significant advancement in point-of-care diagnostics for emergency medicine. The Labcorp Fentanyl Urine Visual Test delivers results in just 10 minutes, providing healthcare providers with critical information when treating suspected fentanyl exposure in emergency departments, hospitals, and clinics.
The launch addresses a growing clinical need as fentanyl exposure remains a significant concern across acute care settings. According to Labcorp (搜索) data, approximately 4% of pre-employment screenings tested positive for fentanyl between 2024 and 2025, while nearly 10% of patients receiving opioid use disorder (搜索) treatment tested positive during the same period.
Enhanced Detection Capabilities
The test employs a sophisticated approach by detecting norfentanyl (搜索), the primary fentanyl metabolite, rather than fentanyl itself. This methodology provides a substantially longer detection window, with norfentanyl remaining present in urine for up to 48 hours after initial exposure. In contrast, fentanyl itself may clear from the system within hours, making detection more challenging in clinical settings.
"When clinicians suspect fentanyl exposure, they need quick, dependable answers to inform care," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp (搜索). "The Labcorp Fentanyl Urine Visual Test delivers results in minutes, helping teams respond quickly and confidently in emergency departments, hospitals and clinics—ultimately supporting better patient outcomes."
Clinical Implementation and Standards
The FDA-cleared test is designed for use by qualified professionals in Clinical Laboratory Improvement Amendments (CLIA)-certified settings. Results are intended for preliminary rapid screening purposes and should be confirmed using appropriate laboratory methods, following standard practice for rapid testing protocols.
Recent guidance from the Association for Diagnostics and Laboratory Medicine (搜索) (ADLM) has emphasized the importance of reliable screening tools in emergency care, particularly as synthetic opioids like fentanyl become increasingly prevalent in clinical presentations.
Labcorp Point of Care Integration
The Fentanyl Urine Visual Test is available through Labcorp (搜索) Point of Care, the company's rebranded division previously known as MEDTOX Diagnostics (搜索). Throughout 2026, product names, packaging, and resources will transition from MEDTOX Diagnostics to the new Labcorp Point of Care branding, reflecting the company's integrated approach to diagnostic services.
This diagnostic advancement represents part of Labcorp (搜索)'s broader portfolio of laboratory services, with the company's nearly 71,000 employees serving clients in approximately 100 countries and performing more than 750 million tests annually for patients worldwide.