Recent Developments in Roadside Drug Testing AG Verstraete Laboratory of Clinical Biology, Ghent University Hospital and Faculty of Medicine and Health Sciences, Ghent University, De Pintelaan 185, Ghent, Belgium Introduction Under both per se and impairment-type legislation, the need for on-site (at the roadside or in a police station) drug testing that was demonstrated in the first ROSITA-project (1999-2000)(1) continues to be expressed by police officers and legislators. The focus is clearly on oral fluid (saliva) testing. The results of ROSITA showed that there was a good concor-dance between qualitative (negative/positive) results for illicit drugs in oral fluid (by gas chromatography-mass spectrometry (GC-MS)) and blood (95% for amphetamines, 89% for cannabis, 99% for cocaine and 91% for opiates)(2). The on-site oral fluid tests evalu-ated by the Rosita project were insufficiently reliable. Since the end of the project, fewer roadside tests have been performed in several countries. Legislation However, on the legislative side, there have been new developments. In the United King-dom, the UK Railways and Transport Safety Act of 2003 (3) became effective in November 2003. It gives a constable the power to administer preliminary tests if the constable rea-sonably suspects:

- that a person is driving, is attempting to drive or is in charge of a motor vehicle on a road or other public place, and has alcohol or a drug in his body or is under the influence of a drug;

- that a person has been driving, attempting to drive or in charge of a motor vehicle on a road or other public place while having alcohol or a drug in his body or while unfit to drive because of a drug, and still has alcohol or a drug in his body or is still under the influence of a drug;

- that the person has committed a traffic offence while the vehicle was in motion;

- if a constable reasonably believes that the person was driving, attempting to drive or in charge of the vehicle at the time of the accident.

Three types of preliminary tests are mentioned: a preliminary breath test, a preliminary impairment test (observation of performance of tasks and other observations of physical state to indicate whether person is unfit to drive) and a preliminary drug test (this involves obtaining a specimen of sweat or saliva and the use of the specimen for the purpose of obtaining an indication whether a person has a drug in his body). In the state of Victoria in Australia, legislation introduced in December 2003 will allow po-lice to perform roadside oral fluid tests for cannabis and methamphetamine (4). It enables a member of the police force to require oral fluid samples from drivers of motor vehicles for the purposes of preliminary testing. A person is eligible for such testing if he or she is—

- found driving or in charge of a motor vehicle; - the driver of a motor vehicle that has been required to stop at a

preliminary testing station; - believed on reasonable grounds to have driven or been in charge in the

preceding three hours of a motor vehicle that has been involved in an accident; or

- believed on reasonable grounds to have been, in the preceding three hours, an occupant of a motor vehicle that has been involved in an accident, and it has not been satisfactorily established which of the occupants of the motor vehicle was the driver.

It enables authorised officers of the Roads Corporation or the Department of Infrastructure to require persons driving or in charge of commercial motor vehicles to undergo a preliminary oral fluid test. The preliminary oral fluid test must be carried out in accordance with the prescribed procedure and only by appropriately trained officers. The prescribed device used in preliminary oral fluid tests may be comprised of a collection unit and a testing unit and one or more other parts. If a preliminary oral fluid test indicates that a person's oral fluid contains a prescribed illicit drug, or if a person refuses or fails to undergo a preliminary oral fluid test, then that person may be required to provide a sample of oral fluid for testing and analysis. The sample of oral fluid required under this provision will only be sent for analysis if the test of the sample indicates that it contains a prescribed illicit drug. It will be the results of the analysis that form the basis of any charge. A person who has been required to provide a sample of oral fluid may be required to provide a sample of blood for analysis if it appears that

(a) that person is unable to furnish the required sample of oral fluid on medi-cal grounds or because of some physical disability or condition; or

(b) the prescribed device is incapable of testing for the presence in the sam-ple of a prescribed illicit drug for any reason whatsoever.

Table 1: Overview of currently available or prototype on-site oral fluid drug tests

Device Manufacturer Website (accessed, Dec 2003)

DrugTest® UPlink™

Dräger Safety, Lübeck, Germany OraSure Technologies, Inc, Beth-lehem, PA 18015, USA

www.draeger.com www.orasure.com

Drugwipe®II Securetec Detektions-Systeme AG, Ottobrunn, Germany

www.securetec.net

Impact® test system

Lifepoint Inc., Ontario, CA 91761, USA

www.lifepointinc.com

On•Site OraLab® Varian Inc, Lake Forest, CA varian-onsite.com OraLine® s.a.t. Test

Sun Biomedical Laboratories, Inc., Blackwood, NJ 08012, USA

www.sunbiomed.com

ORALscreen™ Avitar, Inc., Canton, MA 02021, USA

www.avitarinc.com

Oratect™ Branan Medical Corporation, Irvine, CA 92618, USA

www.brananmedical.com

RapiScan Cozart Bioscience Limited, Abing-don, Oxfordshire, UK

www.cozart.co.uk

Salivascreen ulti med Products GmbH, Ger-many

www.ultimed.org www.salivascreen.de

Smartclip EnviteC-Wismar GmbH, Wismar, Germany

www.envitec.com

New On-site Tests Since the end of the Rosita project in 2000, a lot of progress has been made, and 10 on-site tests are available commercially or as prototypes (see table 1). Since there are very few independent evaluations of the newer on-site oral fluid tests, a EU/US study, Rosita-2 (2003-2005), was started in 2003 to evaluate them at the roadside or in a police station. In 6 European countries (Belgium, France, Finland, Germany, Nor-way and Spain) and 5 US states (Florida, Indiana, Utah, Washington State and Wiscosin), the new on-site tests for drugs in oral fluid will be evaluated and compared to the drugs found by ELISA and chromatographic methods in oral fluid (after sampling with Intercept) and blood. Some preliminary experiments performed with spiked saliva samples in a laboratory have shown that the performance of some on-site tests is becoming acceptable for opiates, methamphetamine (including methylenedioxymethylamphetamine (MDMA) or ecstasy) and amphetamine and to a lesser extent for cocaine or its metabolites, but there are still many problems for THC, where only three devices can detect THC at a concentration of 50 ng/mL or less (see table 2). In addition to tests for the illicit drugs, many manufacturers are developing on-site tests for benzodiazepines in oral fluid. Table 2 Detection limits (ng/mL) of six on-site tests in spiked oral fluid samples (5;6).

Amphetamine THC Morphine Cocaine Methamphetamine

Drugwipe 500 50 20 200 100

Oratect 25 ND 20 40 25

Rapiscan 25 50 80 200 100

OralLab 500 100 80 10 500

Saliva screen NT ND 20 40 25

Uplink 25 20 20 200 25

NT: not tested ND: no THC could be detected, even at 100 ng/mL At the time of writing this proceeding article, there are no results of the field studies of Rosita-2. The start of the field studies was slowed down by a lengthy process in obtaining approval from the institutional review boards and difficulties in specimen collection (many refusals to participate and malfunctions of some collection devices). In March 2004, six centres had started collecting samples and the total number of subjects included in the study was approximately 300 (15% of the planned total in the first collection period). One device gave many problems in collecting oral fluid from subjects suspected of driving un-der the influence of drugs, with a failure rate of 75%. The evaluation of this device was temporarily suspended while an improved device is developed. Based on some prelimi-nary data (screening results that have not been confirmed), sensitivity and specificity of another device were good (> 95% of the qualitative (negative/positive) results of the on-site tests matched the results of ELISA in serum) for opiates, methamphetamine and cocaine, but many false negatives were seen for amphetamine and tetrahydrocannabinol (THC).

Another unsolved problem is the sampling of oral fluid. It has been shown for codeine that the concentration in oral fluid depends on the sampling protocol (7). In people who have recently consumed drugs that cause dry mouth, e.g. amphetamines, cocaine or cannabis, there is little oral fluid and it is very viscous. Different solutions have been tried to solve the viscosity problem, e.g. a dilution with buffer, but this complicates the sampling process. Some authors have shown that THC remains bound to the sampling device and that an organic solvent is needed to release it (8). The variability of the sampling efficiency makes it necessary to evaluate the whole process, and not only the detection limit of the immuno-assay. If the sampling process is more efficient, it could very well be that a device that is less sensitive can detect drug consumption for a longer time than a more sensitive device with a less efficient sampling system. Although a few studies exist (9;10), there is a need for more evaluations of oral fluid drug tests after controlled administration of drugs to vol-unteers, particularly for marihuana. There is a strong need for roadside testing of alternative matrices. The use of e.g. oral fluid has the advantage that the parent drug is detected and that the presence of a drug in oral fluid may correlate better with impairment than the presence of drug metabolites in urine. Obtaining an oral fluid sample can be done under supervision and without embarrassment. But individuals who have recently consumed drugs often have very little and viscous oral fluid. Therefore, obtaining a suitable sample can take 15-20 minutes or be impossible. Although there has been significant progress in the analytical performance of on-site oral fluid drug tests, several problems remain to be addressed before a reliable on-site oral fluid test can be recommended. More research is needed on the influence of collection, adulterants, and other parameters that could violate the integrity of the speci-men, the concentrations seen after passive exposure, and most importantly further re-search is needed to improve the sensitivity for detection of THC and benzodiazepines. References 1. Verstraete AG, Puddu M. General conclusions and recommendations. In: Verstraete

AG, editor. Rosita. Roadside testing assessment. Gent: Rosita consortium, 2001: 393-397.

2. Verstraete AG, Puddu M. Evaluation of different roadside drug tests. In: Verstraete AG, editor. Rosita. Roadside testing assessment. Gent: Rosita consortium, 2001: 167-232.

3. Railways and Transport Safety Act. 2003. 4. Parliament of Victoria. Road safety (drug driving) act 2003. 111/2003. 9-12-2003. 5. Walsh JM, Flegel R, Crouch DJ, Cangianelli L, Baudys J. An evaluation of rapid

point-of-collection oral fluid drug-testing devices. J Anal Toxicol 2003; 27(7):429-439. 6. Walsh JM. An evaluation of oral fluid point of collection testing devices phase 2. 1-21. 1-5-2003. Bethesda, MD, The Walsh Group. 7. O'Neal CL, Crouch DJ, Rollins DE, Fatah AA. The effects of collection methods on

oral fluid codeine concentrations. J Anal Toxicol 2000; 24(7):536-542. 8. Samyn N, De Boeck G, Verstraete AG. The use of oral fluid and sweat wipes for the

detection of drugs of abuse in drivers. J Forensic Sci 2002; 47(6):1380-1387. 9. Niedbala RS, Kardos KW, Fritch DF, Kardos S, Fries T, Waga J et al. Detection of

marijuana use by oral fluid and urine analysis following single-dose administration of smoked and oral marijuana. J Anal Toxicol 2001; 25(5):289-303.

10. Jehanli A, Brannan S, Moore L, Spiehler VR. Blind trials of an onsite saliva drug test for marijuana and opiates. J Forensic Sci 2001; 46(5):1214-1220.