Author: Leo Cangianelli, The Walsh Group, 6701 Democracy Blvd., Suite 300, Bethesda, MD 21807, U.S.A.

Transcription

1 ROSITA II Project: "Evaluation of the Draeger 'Uplink' and Securetec 'DrugWipe 5' Oral Fluid Drug Testing Devices in Hillsborough County, Florida Author: Leo Cangianelli, The Walsh Group, 6701 Democracy Blvd., Suite 300, Bethesda, MD 21807, U.S.A. Date: August 28, 2007 Abstract This study was a collaborative US/EU international effort to assess the prevalence of illegal drug use among drivers failing a standard field sobriety test [i.e. DUI suspects] and to evaluate the effectiveness of oral fluid drug detection technology to detect drug abuse by drivers at the roadside. The project was conducted in major cities in the US and Western Europe by teams composed of scientists working in collaboration with local police. This paper presents analysis of data from one of the U.S. sites that participated in the study. The information was collected by The Walsh Group in partnership with the Hillsborough County Sheriff s Office (HCSO) Tampa, Florida. Two oral fluid drug testing devices were evaluated by HCSO over two collection periods with 169 specimens collected/tested. One of the testing devices, Draeger Uplink was withdrawn from the market in December 2005 and is no longer available, however the results are presented in this report. The results of the Securetec Drugwipe device are also presented herein. Officers and technicians who used the Drugwipe reported it to be very durable and easy to use at the roadside, but lacked sensitivity for detection of THC. Site Coordinators: Sgt. Ron Harrison, HCSO and Karen Hernandez, Contract Technician Partners: Hillsborough County Sheriff s Office, Tampa, Florida, Major Eugene Stokes, ( ), Major Paul Davis, ( ), Site Coordinator, Sgt. Ronald Harrison ( ), Sgt. Laura Regan, ( ), and Karen Hernandez, ( ). Introduction The Walsh Group in collaboration with Dr. Alain Verstraete [University of Ghent, Belgium] established a collaborative agreement to conduct a joint US/European international study to assess the prevalence of illegal drug use among drivers failing a standard field sobriety test and determine the feasibility of police use of saliva drug testing devices at the roadside to verify drug use by drivers. This project was conducted in major cities in the US and Western Europe by teams composed of scientists working in collaboration with local police. Intent of the project was to build on the success and the lessons learned in the original European ROSITA project that evaluated drug testing devices in eight European nations. For this project, four teams were identified in the United States located in Washington State, Salt Lake City, Utah, Wisconsin State and Florida. This section reports on the results of the study from the Hillsborough County Sheriff s Office located near Tampa, Florida, United States of America. The Florida DUID law states that a person is guilty of the offense of driving under the influence and is subject to punishment as provided in subsection (2) if the person is driving or in actual physical control of a vehicle within the state and: (a) The person is under the influence of any chemical substance or any controlled substance, when affected to the extent that the person s

2 normal faculties are impaired. There is implied consent for testing of urine only. Special circumstances exist requiring a driver to provide a blood sample for testing when he/she has been involved in a crash resulting in death or serious bodily injury. The Florida law is silent on the collection of saliva as part of a DUI evaluation. As a result, prior to initiating data collection in Florida, The Walsh Group asked the Florida State Attorney General for and received an exception to allow police officers to collect oral fluid pursuant to the study protocol. Methods Overview: During the initial specimen collection phase subjects were recruited by police officers after a DUI stop, and, if suspected of being under the influence of drugs, were taken to the central breath testing facility (CBT) where consent was obtained and further testing under the protocol. All officers were trained at the beginning of the collection period on the administrative procedures to be used (i.e. obtaining consent of the subject and data collection/recording) and on the operation of the oral fluid drug testing device(s). This training was repeated on two other occasions during the initial collection phase to sustain officer interest and refresh them regarding the project requirements. During the later collection phase HCSO changed some of the procedures to increase subject recruitment for the study. One element that helped to improve the recruitment of subjects was the addition of a new Blood Alcohol Mobile Testing Unit (Batmobile) that was deployed by HCSO in November Also, a research technician was hired to ride along with the police officers in the new Batmobile; and, when the Batmobile was not in use, to be positioned at the CBT during peak hours of most week-ends. The technician s responsibilities were to approach, interview and obtain consent from participating subjects; collect and test specimens; complete data sheets; ship completed subject packs to The Walsh Group; ship Intercept specimens to CHT for further testing; and assist the site coordinator as may otherwise be required. This new procedure worked well in other U.S. sites and helped HCSO overcome many of the recruitment problems encountered earlier. Devices Assigned: 1. UpLink: Initially, HCSO was assigned the Draeger UpLink device which had been evaluated in the second round of lab tests conducted by The Walsh Group and The Center For Human Toxicology. (Journal of Analytical Toxicology, Vol. 29, May/June 2005). This device in described in the following illustration: Matrix: Saliva, [Collection kit includes: collection device, buffer cartridge, and test cassette] Tests Available: Methamphetamine, Amphetamines, Opiates, Cocaine, marijuana, and PCP Number of parameters per device: Six Not FDA approved Storage conditions: Room temperature Manipulations to obtain a result: Collect a saliva sample with the swab collection sponge.

3 1) Insert the buffer cartridge into the lower groove of the test cassette by aligning lower tabs on the cartridge with notches on the cassette. Rock cap and remove. 2) Insert the sample collection device into the buffer cartridge and press down on the sample collection device (notice that the sample collection device clicks slightly into place and a cracking sound can be heard when it is pushed down firmly). 3) Remove the handle of the sample collection device by means of a quarter turn anticlockwise. 4) Close buffer cartridge. Allow 4 minutes of incubation time. 5) Turn the buffer cartridge clockwise until the upper groove is positioned above the groove of the test cassette. Push down the buffer cartridge firmly until the cartridge wings touch the edge of the cassette. Allow the fluid to develop for 8 minutes. 6) After 8 minutes enter sample ID in the analyzer and insert the cassette into the analyzer. 7) Analyzer will indicate the door is closed and read cycle has begun. Analyzer will report results in 4 minutes. Interpretation of the result: Digital read-out Save specimen for confirmation: Possible User friendliness: Fair 2. Drugwipe: From April 2006 through November 2006 HCSO evaluated the Drugwipe device after the UpLink was withdrawn. The Drugwipe device is described in the following illustration: Drugwipe Manufactured by Securetec, Ottobrunn, Germany Securetec s Drugwipe devices are individually packaged and each device contains a collection pad and one or two test strip membranes. Each membrane can contain one to three drug tests. The removable cover contains a collection pad that is used to collect the specimen. The body of the device (detection element) contains a membrane with an attached absorbent fleece. The membrane contains the drug test(s) and an internal control that indicates a valid test. This product requires four operational steps: 1) Specimen collection In the standard protocol, users are instructed to wipe the test pad gently over the tongue; 2) After collecting the specimen the collection pad cover is reassembled onto the body of the device coming into direct contact with the drug-test membrane strip; 3) The absorbent fleece on the end of the membrane strip is dipped in tap water for 10 seconds which initiates flow across the membrane; 4) Drug test and validity results are visually read after 10 minutes. Specimens collected: HCSO collected two oral fluid specimens and urine. One oral fluid specimen was collected using the procedures for the assigned device and the second collected in the Intercept collection device and forwarded in the transport vial to CHT for laboratory screening and confirmation. The urine specimen was collected as required by Florida law for a

4 DUID offense and was analyzed by the FDLE laboratory. The urine results were forwarded to The Walsh Group for inclusion in the final analysis. Drugs tested: HCSO relied primarily on the results of the saliva laboratory (Intercept) tests and urine results obtained from the Florida Department of Law Enforcement (FDLE) Laboratory to validate the rapid oral fluid drug testing devices. The primary reference was the saliva laboratory (Intercept) test results. Each specimen collected was tested for a core set of drugs as follows: UpLink Saliva rapid test: The UpLink device tested oral fluid for amphetamine, cocaine, methamphetamine, opiates, and THC. The Draeger Uplink on site device profile: Meth. 25 ng/ml THC 25 ng/ml Amp. 25 ng/ml Opiates 20 ng/ml Cocaine 200 ng/ml Drugwipe rapid test: The Drugwipe on-site device tested for amphetamines, cocaine, methamphetamines, THC and opiates. The Drugwipe rapid test profile: Amp 100 Opiates 20 Meth 100 THC 30 Coc 50 THC-COOH 3 Laboratory saliva test (Intercept): CHT screened the laboratory saliva (Intercept) specimen for cannabis, cocaine, amphetamines, methamphetamines, opiates, and benzodiazepines. A confirmation test using GC/MS or LC/MS was conducted whenever there was inconsistency between the saliva rapid screen (Oratect) and the saliva lab (Intercept) screen. CHT Oral Fluid laboratory screening test profile Amp/meth 50/25 ng/ml Cocaine 8 ng/ml Benzodiazepines 2 ng/ml Opiates 20 ng/ml THC 2 ng/ml Urine laboratory test: The FDLE laboratory tests were screening tests and tested for THC, cocaine, amphetamines, methamphetamines, opiates, and benzodiazepines. Screened positives were confirmed using GC/MS. The FDLE Urine laboratory test profile: Amphetamines 500 ng/ml Cocaine metabolites 300 ng/ml Benzodiazepines 100 ng/ml Methadone 200 ng/ml THC 50 ng/ml Barbiturates 300 ng/ml Opiates 200 ng/ml Inclusion Criteria: Under the protocol standard police measures were used to identify drivers suspected to be under the influence of alcohol or drugs. Some criteria that may be used by police officers as reasonable suspicion of drug use are: The driver s appearance, behavior, or odor indicate drug use The driver fails the SFST or equivalent test; or The driver has illicit drugs or drug paraphernalia on his/her person or in the vehicle; or The driver admits to using drugs; or

5 Modified 3_16_06 The police officer believes that the BAC level is inconsistent with the level of observed impairment Procedures: For drivers who met the inclusion criteria, the technician recruited, instructed and obtained consent from the subject collecting oral fluid and urine specimens either in the Batmobile or at the CBT. This was accomplished after all evidential tests on the subject and paper work for the arrest were completed. 1. One oral fluid specimen was tested by the research technician using the UpLink on-site drug testing device and a second oral fluid specimen was collected using the Intercept saliva collector. The results of the UpLink device were read from the printout by the technician/police officer and recorded on the data sheet. The second Intercept specimen was annotated with the case number on the Intercept transport vial and placed in a plastic envelope along with the data and consent sheets. This completed subject package was retained for final review by the technician and/or site coordinator who aggregated and sent the Intercept vials to CHT for further testing. The data sheets and consent forms were forwarded to The Walsh Group for data entry and retention. 2. Urine specimens were handled in accordance with normal site procedures and sent to the FDLE laboratory for testing. After urine results were received from the FDLE laboratory they were also forwarded to The Walsh Group for data entry. Consent Form: Each subject included in the study was asked to sign a consent form prior to participating and prior to collecting the specimen(s). Normally, this was completed after all evidentiary specimens and forms for the arrest were concluded by the police officer. 11

6 Modified 3_16_06 UpLink Device Field Test Results Total THC Coc Amp Opi Total assays conducted n True positives True negatives False positives False negatives Sensitivity (%) 65.0% 73.3% 100.0% 0.0% Specificity (%) 89.7% 98.6% 96.5% 100.0% Positive predictive value (%) 65.0% 91.7% 40.0% Negative predictive value (%) 89.7% 94.7% 100.0% 97.7% Accuracy (%) 84.1% 94.3% 96.6% 97.7% Invalid

7 Modified 3_16_06 Drugwipe Device Field Test Results Total THC Coc Amp Opi Total assays conducted n True positives True negatives False positives False negatives Sensitivity (%) 20.0% 66.7% 0.0% 0.0% Specificity (%) 84.5% 98.5% 98.8% 97.5% Positive predictive value (%) 15.4% 90.9% 0.0% 0.0% Negative predictive value (%) 88.2% 92.9% 100.0% 100.0% Accuracy (%) 76.5% 92.6% 98.8% 97.5% Invalid Conclusions 1. The instrumented UpLink device worked well in a stable setting such as the Batmobile or the centralized BAT center where sufficient room and power were available. The device however, had some limitations: Initial results indicate that the sensitivity for detecting THC is still not as good as the police would like to see it. Reliability of the instrument was satisfactory and support from Draeger for any problems that developed over the six month period of use was excellent. All of the information is moot in view of the withdrawal of the instrument from the drug testing marketplace. 2. The Drugwipe device was considered as most durable and acceptable by police Officers and technicians were able to successfully perform Drugwipe testing In poor light Drugwipe can be difficult to read with naked eye. Florida s experience with use of the Drugwipe Reader produced clear, readable results. Florida field study results for Drugwipe showed a low sensitivity rate for THC of 20.0% with an overall accuracy of 76.5%. Key Words: Oral Fluid, Point of Collection, DUID 13