Meeting National Safety Council Recommendations: Accurate Rapid Tests and Laboratory Confirmation Procedures for Fentanyl and Prevalent Opioids in Oral Fluid

Meeting National Safety Council Recommendations: Accurate Rapid Tests and Laboratory Confirmation Procedures for Fentanyl and Prevalent Opioids in Oral Fluid

Description of the problem: Fentanyl and synthetic opioid use, abuse, overdose, and deaths are currently occurring at an alarming rate in the USA. The law enforcement community, the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) are all keenly aware of the urgency in addressing an unmet public health need to identify opioid overdose in individuals as rapidly as possible.  Individual health outcomes will be significantly improved by allowing the correct treatments to be administered quickly.  

Proposed solution:
a. development of an inexpensive, visually read testing device which allows the operator to rapidly identify the presence of fentanyl and/or other opioids in oral fluid taken from the subject, and
b. development of environmentally friendly confirmatory laboratory procedures for the remaining specimen.

The device is “Made in America”
The same specimen used for rapid testing will be confirmed by newly developed environmentally friendly laboratory procedures
Laboratory procedures will allow comparison of on-site results from clinical specimens to confirmatory methods which are necessary to perform characterization and performance of the device
Laboratory procedures will be published and provided to both forensic and clinical facilities, to assist in their support of law enforcement

Drugs in oral fluid reflect related compounds circulating in blood, therefore oral fluid analysis is indicative of free drugs in the body. The new device for presumptive testing, followed by laboratory confirmation for evidential analysis will promote the use of oral fluid in many areas including: identification of drugged drivers, in suspected overdose antemortem situations, in prisons testing and among parolees.

Commercially available instrumented devices are expensive and require training of the officers to operate correctly. Currently no commercially available instrumented device includes fentanyl or oxycodone analysis, and none are “Made in America”.

Commercially available non-instrumented (visually read) devices are generally inexpensive and disposable, but none are manufactured in the USA. The current commercially available devices do not include fentanyl, which is the major issue in the opioid crisis.

The success of our project will provide a solution to a currently unmet public health need, assist law enforcement in assessing various overdose situations, and will be useful in opioid treatment clinics. CA/NCF