Government Health Leaders Request Additional Data on Drug Test Strips

Although drug-checking tools such as fentanyl test strips have been championed as critical harm-reduction tools in the opioid epidemic, additional data and research are required to assess their effectiveness correctly.

In a recent commentary published in the New England Journal of Medicine, leaders at the National Institutes of Health and the United States Food and Drug Administration, including Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA), and Robert M. Califf, MD, FDA Commissioner, called on the industry to address gaps in research, development, and implementation.

While some healthcare facilities and public health organizations have adopted these tools, they acknowledge the need for more information on their effectiveness and accuracy. For example, a recent collaboration between the City of Philadelphia Department of Public Health and the Center for Forensic Science Research and Education tested strips that detect xylazine in opioids.

Insights from their research revealed that the strips were 100% sensitive, 85% specific, and 91% precise. Even with the positive results, experts warn that future studies are necessary to analyze the utility of the strips as a public health tool.

“These tools have the potential to save lives and to serve as an important part of harm reduction toolkits but often remain inaccessible because of gaps in research and various other barriers, including state or legal prohibitions,” noted the NIH Press Release.

“This call to action encourages new collaborations among researchers and agencies to ensure the effectiveness of fentanyl test strips and promote the development of additional drug-checking technologies. It also encourages the reduction of barriers that inhibit use of these technologies where not prohibited by law.”

Currently, the FDA does not typically monitor substance detection tools; however, assessing the validity of the tools and the feasibility of their distribution will be critical to integrating them and addressing the ever-present opioid crisis in the US.

“NIH welcomes research proposals on fentanyl test strips and other drug checking and screening tools. The FDA has provided premarket clearance for laboratory-based tests to detect fentanyl in urine and hair and welcomes the opportunity to work with manufacturers on point-of-care devices intended for testing human specimens. This would be particularly valuable in clinical settings to help monitor critical trends and outcomes and aid in clinical evaluations of substance use,” concluded the press release.