Dual-Target Accurate Fentanyl Tracking, Covering All Professional and Self-Testing Scenarios

Recently, Advin Biotech, the U.S. subsidiary of Biotest, announced that its VINScreen^TM series urine testing products – the VINScreen Urine Drug Test Cup and the VINScreen Urine Drug Home Test Cup – have officially received U.S. Food and Drug Administration (FDA) 510(k) clearance (Clearance Number: K252867) and are now available for marketing in the United States. This product series can simultaneously detect both Fentanyl parent drug and its metabolite (Norfentanyl) in a single urine cup, significantly improving the sensitivity of fentanyl detection. It provides a comprehensive testing solution ranging from professional institutions to home settings, addressing the increasingly severe fentanyl abuse crisis.

The Fentanyl Crisis: An Urgent Need for Efficient Testing Solutions 

According to data from the U.S. Centers for Disease Control and Prevention (CDC), in 2024 alone, over 48,000 deaths in the United States involved synthetic opioids, with fentanyl being the primary culprit. Statistics from the U.S. Drug Enforcement Administration further indicate that the amount of illicit fentanyl seized in 2024 equates to more than 380 million lethal doses, with just 2 milligrams of fentanyl being potentially fatal. This severe situation highlights the urgent need for comprehensive and accurate testing solutions. 

Technological Breakthrough: High-Sensitivity Dual-Analyte Detection Enhances Accuracy and Reliability 

The VINScreenTM Urine Drug Test Cup cleared by Advin Biotech offers extremely high sensitivity for fentanyl detection. Its detection threshold for the Fentanyl parent drug is 1 ng/ml, and for Norfentanyl it is 5 ng/ml. By simultaneously detecting both the Fentanyl parent drug and its metabolite Norfentanyl, it effectively addresses the potential for false negatives caused by the short half-life of the Fentanyl parent drug. This provides a more reliable indicator for detecting fentanyl abuse in most application scenarios. 

Application Scenarios: Dual Coverage for Professional Testing and Home Self-Testing 

The cleared VINScreen^TM series urine drug test cups include both professional and home use versions. The Professional Version is suitable for professional settings such as clinics, rehabilitation centers, and forensic testing, meeting high-throughput and high-compliance testing needs. The Home Version is designed for simplicity, providing non-professionals with a fast and private preliminary screening method, aiding in the early detection of fentanyl use risk and buying valuable time for intervention and treatment. 

The VINScreen Urine Drug Home Test Cup utilizes immunochromatography to rapidly detect 18 common drugs of abuse in human urine.

About Advin Biotech 

Advin Biotech, a key subsidiary of Biotest, consistently focuses on the research, development, and innovation of drug abuse testing technologies. The FDA clearance of the VINScreen^TM Urine Drug Test Cup further solidifies its leading position in the field of rapid drug abuse testing in the United States. The company will continue to uphold the philosophy of "Innovation, Accuracy, and Efficiency," serving global customers with products of exceptional performance and reliable quality, contributing the "Biotest Strength" to safeguarding human health.