United States Department of Transportation
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Evaluation of On-Site Oral Fluid Drug Screening Technology
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2021-03-01
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[PDF-6.50 MB]
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Edition:Final Report, 10/2016-12/2017
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Abstract:Oral fluid has emerged as a popular matrix for drug detection in criminal justice, workplace, and impaired-driving populations. The advantages of oral fluid compared to blood and urine specimens include that the sample collection is a noninvasive procedure with minimal potential for adulteration. Additionally, oral fluid samples can be collected proximate to the time of driving, allowing for better correlation between signs and symptoms of impairment observed at the time of the arrest as compared to drugs detected in a biological sample collected later. With the increase in popularity of this matrix, several point-of-contact oral fluid devices have been developed and marketed for use in the field without any controlled assessment to evaluate their applicability and quality. The purpose of this evaluation was to explore the practical aspects of designing and performing tests on the latest generation of oral fluid devices to assess their accuracy, reliability and performance to specification. Five devices, the Dräger DrugTest 5000 (DDT5000), Dräger DrugCheck 3000 (DDC3000), Securetec DrugWipe S 5-Panel (DrugWipe), the Alere DDS2 Mobile System (DDS2) and the AquilaScan Oral Fluids Testing Detection System were included in the evaluation. An appropriate scope of testing and cutoff concentrations was based on two important previous studies: the Roadside Testing Assessment (ROSITA), which recommended greater 90% sensitivity and specificity and greater than 95 percent accuracy, and Driving Under the Influence of Drugs, Alcohol and Medicines (DRUID), which recommended greater than 80 percent sensitivity, specificity and accuracy. Based on the summation of all testing performed for each device, the DDT5000, the DDC3000, and each of their individual assays demonstrated performance consistent with the requirements of the ROSITA group. The DDS2 data, in aggregate, also met the performance requirements for ROSITA; however, the THC assay did not. None of the individual assays on the DrugWipe or the AquilaScan met the performance requirement of ROSITA, nor did the performance of either device in aggregate. The DDT5000, DDC3000 and DDS2 in aggregate also met the performance requirements for DRUID. In its Moving Ahead for Progress in the 21st Century (MAP-21) Act, Congress directed NHTSA to establish a cooperative program — the National Cooperative Research and Evaluation Program (NCREP) — to conduct research and evaluations of State highway safety countermeasures. NCREP was continued in the Fixing America’s Surface Transportation (FAST) Act. This program is administered by NHTSA and managed jointly by NHTSA and the Governors Highway Safety Association (GHSA). Each year, the States (through GHSA) identify potential highway safety research or evaluation topics they believe are important for informing State policy, planning, and programmatic activities. One such topic identified by GHSA, an evaluation of on-site oral fluid drug screening devices, formed the basis for this project.
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