Laboratory evaluation and field application of roadside oral fluid collectors and drug testing devices.

This study was a part of a collaborative U.S./E.U. international research effort (Roadside Testing Assessment, ROSITA II) to assess illegal drug use among motor vehicle operators suspected of driving while under the influence of drugs and to evaluate the effectiveness of point-of-collection oral fluid drug detection technologies. A goal of the study was to assess commercial oral fluid drug testing devices for potential use in law enforcement. Ten devices were evaluated in the laboratory for their ability to meet manufacturers' claimed (and proposed) cutoff concentrations for the detection of amphetamine(s), cocaine/metabolite, opiates, cannabinoids, and benzodiazepines (2 devices). The field study portion of the research was conducted in major cities in the United States and Western Europe by teams of scientists working in collaboration with the local police. In Salt Lake City, Utah, the Drugwipe, Securetec, Ottobrunn, Germany (Securetec) oral fluids drug testing device was also evaluated in the field by testing suspected drug-impaired drivers. During the initial phase of the field study, 40 subjects were recruited. Drugwipe results were compared with laboratory-based immunoassay and mass spectrometry results and demonstrated that calculated sensitivities were between 75% and 100% depending on drug class. Specificities varied from 36% for cannabinoids to over 95% for opiates. During the second phase of the field study, 267 subjects were recruited. The Drugwipe sensitivities were 36.4%, 35.9%, 42.9%, and 7.7%, respectively, for amphetamine(s), cocaine, opiates, and cannabinoids. The Drugwipe specificities were 99.2%, 97.4%, 99.6%, and 99.6%, respectively, for amphetamine(s), cocaine, opiates, and cannabinoids. Drugwipe failed to meet the study criteria for acceptable device performance, required performance sensitivities, and specificities 90% or greater.

Evaluation of ten oral fluid point-of-collection drug-testing devices.

Previously, the laboratory evaluations of six point-of-collection oral fluid (POC-OF) drug testing devices were reported. Four additional devices, Oralstat (American Bio Medica); SmartClip (Envitec); Impact (LifePoint); and OraLine IV s.a.t (Sun Biomedical Laboratories), were recently evaluated for their ability to meet the claimed (and proposed) cutoff concentrations set by the manufacturers for the detection of amphetamine(s), cocaine/metabolite, opiates, and cannabinoids (Oralstat also benzodiazepines). With the exception of the Sun Biomedical device, actual false-positive results were not encountered. Most devices performed well for the detection of opiates and amphetamine(s), but approximately half had amphetamine(s) cutoff concentrations greater than that proposed by the Substance Abuse and Mental Health Services Administration (SAMHSA). Only three devices had cocaine cutoffs less than or equal to 20 ng/mL (SAMHSA), and a number of false-negative results were obtained. The devices still were not capable of detecting Delta(9)-tetrahydrocannabinol at 4 ng/mL (SAMHSA). However, sensitivities improved since the initial studies, and approximately half of the devices met the THC-COOH cutoff proposed by SAMHSA. Results from the current and previous evaluations are presented in the paper and indicate that the sensitivity and performance of commercial OF drug testing devices is improving, but remains problematic for the reliable detection of cannabinoid use.

An evaluation of selected oral fluid point-of-collection drug-testing devices.

Point-of-collection oral fluids drug-testing devices are being marketed for a variety of medico-legal purposes where they may complement existing technologies and be used to detect drugs following recent ingestion. To assess the utility of these devices for use in drugged-driving investigations, we performed a laboratory evaluation of four devices and those results were published previously. In the study reported here, two more devices, Oratect(R) (Branan) and Uplink(R) (OraSure), were evaluated for their ability to detect amphetamines, cocaine, opiates, and cannabinoids. An additional device, Drugwipe (Securtec), was evaluated for the detection of cocaine and cannabinoids. Each of the devices was assessed for their ability to meet the manufacturers' claimed cutoff concentrations and to meet cutoffs proposed for federal workplace programs. In general, the Branan and OraSure devices detected amphetamine, methamphetamine, opiates, and cannabinoid metabolite (THC-COOH) well in the concentration ranges approximating those proposed by the Substance Abuse and Mental Health Services Administration (SAMHSA), but all three devices performed poorly in detecting Delta9-tetrahydrocannabinol (THC) at the proposed SAMHSA cutoff. The ability to accurately and reliably detect cocaine was dependent on the individual device, and the Branan and Securetec devices were more effective than OraSure at detecting parent cocaine.

Drug and alcohol use among drivers admitted to a Level-1 trauma center.

The purpose of this research was to determine the incidence and prevalence of drug use, alcohol use, and the combination of drug and alcohol use among motor vehicle crash (MVC) victims admitted to a Level-1 trauma center. In a 90-day study, nearly two-thirds of trauma center admissions were victims of motor vehicle crashes. Blood and urine was collected from 168 MVC victims of whom 108 were identified as the driver in the crash. Toxicology results indicated that 65.7% of drivers tested positive for either commonly abused drugs or alcohol. More than half of the drivers tested positive for drugs (50.9%) other than alcohol, with one in four drivers testing positive for marijuana use. About one-third of those using drugs had also been drinking, but alcohol was detected in only 30.6% of all injured drivers. Within the total MVC patient pool, passenger drug/alcohol use was equivalent to the driver population; however, injured pedestrians had higher rates of alcohol only than other MVC victims. There were no significant differences in drug and alcohol use between MVCs and trauma admissions of other causes. Of the patients with positive toxicology results, less than half (42%) were referred for evaluation for substance abuse disorders.

Epidemiology of alcohol and other drug use among motor vehicle crash victims admitted to a trauma center.

The objectives of this research were to (1) determine the incidence and prevalence of alcohol and other drug use among motor vehicle crash (MVC) victims admitted to a regional Level-I trauma center, and (2) to examine the utility of using a rapid point-of-collection (POC) drug-testing device to identify MVC patients with drug involvement. Blood and urine specimens were routinely collected per clinical protocol for each MVC victim at the time of admission. Blood alcohol concentration (BAC) levels were determined per standard clinical protocol. Clinical urine specimens were routinely split so that a POC drug-testing device for the detection of commonly abused drugs (Marijuana, Cocaine, Amphetamines, Methamphetamines, and Opiates) could be compared to that of the standard hospital laboratory analysis of each urine specimen (which also included Barbiturates and Benzodiazepines). In the six-month period of this study, nearly two-thirds of trauma center admissions were victims of motor vehicle crashes. During this time, blood and urine was collected from 322 MVC victims. Toxicology results indicated that 59.3% of MVC victims tested positive for either commonly abused drugs or alcohol. More patients tested positive for drug use than tested positive for alcohol, with 33.5% testing positive for drug use only, 15.8% testing positive for alcohol use only, and 9.9% testing positive for both drugs and alcohol. Less than half (45.2%) of the substance-abusing patients in this study would have been identified by an alcohol test alone. After alcohol, marijuana and benzodiazepines were the most frequently detected drugs. Point of collection (POC) test results correlated well with laboratory results and provide important information to initiate rapid intervention/treatment for substance use problems among injured patients.

An evaluation of rapid point-of-collection oral fluid drug-testing devices.

New technology is currently being marketed to rapidly test oral fluids for drugs of abuse at the point of collection (POC). There are no nationally accepted standards or cutoff concentrations for detecting drugs in oral fluids and for most analytes there are significant differences in cutoff concentrations across devices. Four devices were evaluated (OralLab), RapiScan, Drugwipe, and SalivaScreen) for their ability to meet manufacturers claims, and proposed federal standards for criminal justice and workplace programs. Human oral fluid fortified with known quantities of drug [drug(s) or metabolite(s)] was used to test these devices. Overall, the performance of these rapid POC oral fluid drug-testing devices was quite variable. Some devices performed well for the analysis of some drug classes but poorly for others. In general, most devices performed well for the detection of methamphetamine and opiates, but all performed poorly for the detection of cannabinoids. The ability to accurately and reliably detect cocaine and amphetamine was dependent on the individual device.

Relationships between urinalysis testing for substance use, medical expenditures, and the occurrence of injuries at a large manufacturing firm.

Drug use among employees continues to be a serious concern for American employers. Over 80% of the large employers in the United States use some form of testing to detect drug use, but this practice is controversial and the cost-effectiveness of drug testing remains largely unknown. This study begins an empirical investigation of the consequences of drug testing by estimating its impact on medical care expenditures and injury rates at a large manufacturing firm in 1996-1999. Multiple regression analyses of a pooled cross-sectional time-series data set were used to separate the impact of drug testing from other factors and to help find the optimal level of testing that was associated with minimum medical expenditures. Results indicated that medical expenditures would be minimized when 42% of the employees in a calendar quarter were drug tested. This implies that, on average, employees should be tested 1.68 times a year. The results also indicated that doubling the testing rate would reduce the odds of incurring any injuries on the job by over half, but the injury rate was already so low that this impact was very small. Hopefully the results of this study will inform the policy debate over drug testing by focusing on real data, as opposed to supposition or political considerations that seem to dominate many discussions.