RD
th
Chairman: Pascal Kintz
WELCOME 9.00 a.m. by M ANFRED R.
M OELLER , ILMH, G ERMANY
In his welcome speech, M
ANFRED
M
OELLER
welcomed the participants and expressed his wish that everybody has enjoyed the Rosita-symposium the day before, and that the meeting will be successful and informative.
CO-ORDINATOR’S INTERIM REPORT 9.05 a.m. by A LAIN V ERSTRAETE , RUG, B ELGIUM
In a small summary, A LAIN V ERSTRAETE gave some details about the state of the project until
November 8th:
At the moment 3 deliverables (WP1 – WP3) were sent to the European Commission for review. Two are already accepted, the last one has to wait until November 8th.
A progress report of 15 pages should be completed until the end of January, so all partners are urged to send their cost statements until then.
Generally, press contributions and articles should be sent to the co-ordinator.
Some notes from the SOFT meeting (Puerto Rico, Oct 9-14 1999) were given:
The National Laboratory Certification Program is considering the establishment of proficiency or performance testing programs for laboratories, especially for drug abuse in hair, sweat and oral fluids. With planning the start for April 1st 2000, it is late for the ROSITA project but still interesting to try to join this program.
At this SOFT meeting, a presentation by Wayne Jeffrey from Canada was given about a study where the evaluation with saliva levels was compared (date of presentation of the study not yet clear).
During the summary of A.
V ERSTRAETE , insisting suggestions about a 5th Rosita meeting appeared. It was discussed if it should be a working meeting or more a presentation.

Further, there exists an other European project on saliva testing. Martin Ullmann, the coordinator, will be present on the second meeting day, and he will provide some information about this project.
At the last Rosita-meeting in Santiago de Compostela, plasma samples, which are used in the quality control of the French society, were distributed for quality controls to the eight Rosita labs (Standard deviations, and gradation coefficients of all samples were made). A.
V ERSTRAETE presented the results: Generally, they were quite good (some were better than the results of the French society) but mostly, the labs had expected a better outcome. In some countries, blood was not analysed for all metabolites, e.g. only for THC, not for COOH-THC.
It was suggested to repeat the quality control, probably made by other companies.
DISCUSSION ABOUT WP4: STATUS OF THE COUNTRIES
N
ELE
S
AMYN
, NICC, B
ELGIUM
9:37 a.m.
N
ELE
S
AMYN
explained that the Rosita- project is realised by a co-operation of NICC, the
Belgian State Police and the Dutch Railway Police, with adjustments to the needs and recommendations of the new Belgian law on DUID. An evaluation of on-site devices is practised on occasion of police checks to test suspect drivers, mostly performed on the border
Belgium-The Netherlands-France, on “classical” sites like dancing areas, and furthermore on controls performed on the possession of drugs, e.g. “off the roadside” at the Central station in
Antwerp.
To the procedure:
If a driver appears to be impaired, a trained member of the State Police performs the Dipro
Drugscreen 5 panel (for AMP, MAMP, COC, OPI, CAN) as the „official“ urine test, recommended by justice. Other urine tests, as there are e.g. Roche Testcup / Teststik, Syva
Rapidtest , Rapid Drug Screen and others, are applied additionally by NICC on-site on the same urine sample. It was tried to make the police officers familiar with the use of these tests.
The total number of tested persons should be 200, whereas the clinical data were made for correlation between on-site and laboratory results (screening and confirmation by means of
FPIA / GC-MS) on blood (considering the legal cut-off values) and urine. Furthermore, saliva and sometimes sweat samples are collected:
-
-
For testing saliva, the Securetec Drugwipe - applied on the tongue and now read out electronically- and the Avitar Oral Screen for morphine are used. Reference samples are taken in any case by spitting in a plastic tube, and frozen immediately. Due of the lack of volume, GC-MS is made on max. 2 parameters. The Oral Screen sometimes makes problems with the samples, but there don’t exist enough subjects yet for further conclusions.
Sweat samples were only collected in interesting cases, with „Securetec“ fleece, soaked in
70 % isopropanol and wiped on the forehead, normally analyses with GC-MS in 1 parameter, possibly in two. The Drugwipe is applied to the forehead, and as for saliva, the result can be interpreted electronically.

N.
S AMYN said that is impossible to give preliminary results of all body fluids yet, and she named arisen problems and asked for advice.
S
TEFAN
S
TEINMEYER
, ILMH, G
ERMANY
09:59 a.m.
S TEFAN S TEINMEYER started with the explanation of the detailed process to check for DUI at the roadside, the implementing regulation between the police and the ILMH, and the documentation of the results (including a „confidential report“ for each test version, filled out by the police officers who became familiar with the tests).
As important it was pointed out that the police officers shall use - in addition to the urine and saliva/sweat device(s) which shall be tested - a reliable reference system (which is decisive for further measures, e.g. blood sampling), in order to ensure the on-site detection of positive samples; recommended as such a reference is the combination of Mahsan DOA 4 and
Frontline AMP , due to practical knowledge previously won by the ILMH; nevertheless, both tests are also subject of investigation of Rosita.
To cover a broad spectrum of versions of test devices, a rotation after about 3 months or the distribution of new devices, respectively, is planned. As upper limit of tests per version which shall be tested the quantity of 200 devices was set; if this number should be achieved before the end of the testing phase, the investigation of the respective test version can be stopped.
In June 1999, a decree was distributed by the Ministry of the Interior of Saarland to its three traffic departments (TPD east, TPD west, TPD centre), in which the organizational and practical methodology of the police concretely is described regarding roadside drug testing in the context of Rosita. For that, the performance of Rosita is not dependant on voluntary help of the police, it is supported by an official order on an administrative basis.
Currently used by the police traffic units are (divided differently): Test Cup (Roche), Rapid
Drug Screen (American Biomedica), Syva Rapid Cup (Dade Behring), Drugwipe (Securetec) .
A brief overview was given about the experiences already made by the police and the laboratory validation results of the so far used devices:
-
-
DOA4 (Mahsan) total number 126, documented failures 1, correct results (lab. confirmed) 107 (85,6%) false positive 1 (COC), false negative 9 (3 CAN, 6 AMP), doubtful 12 (3 COC, 2 OPI, 5
AMP, 2 CAN)
Frontline AMP (Roche) total number 61, documented failures 0, correct results (lab. confirmed) 48 (78,7%) false positive 10, false negative 0, doubtful 3
-
-
Rapid Drug Screen (ABM) total number 12, documented failures 2, correct results (lab. confirmed) 7 (70,0%) false positive 4 (2 CAN, 1 MAMP, 1 COC), false negative 0, doubtful 1 (MAMP) first response of the police: sometimes thin, weak lines (esp. CAN), urin-wet testing card
- Low number of tests, statistically insufficient yet -
Test Cup (Roche) total number 50, documented failures 5, correct results (lab. confirmed) 39 (86,6%) false positive 1 (CAN), false negative 2 (CAN, AMP), doubtful 3 (COC, OPI, AMP) first response of the police: test-position of the lid not very clear, closing the lid difficult
(hooking), sometimes not working

-
Syva Rapid Cup (Dade Behring) total number 73, documented failures 7, correct results (lab. confirmed) 62 (93,9%) false positive 1(AMP), false negative 0, doubtful 5 (1 CAN, 2 COC, 2 AMP) first response of the police: difficult to close without leaking, sometimes partly not working.
-
Drugwipe AMP / COC / OPI (Securetec) total number 51 / 33 / 30, documented failures 1/0/0, correct results (lab. confirmed) 27 (54,0%) / 24 (72,7%) / 25 (83,3%), false positive 16 / 3 / 1, false negative 0 / 0 / 1, doubtful 7 / 6 / 3 first response of the police: no CAN in the study, readability difficult (red color difficult to make out in red street light conditions; no control field)
Different sources of trouble and possibilities of their elimination were discussed, e.g. the handling (esp. reading of results) by the police, the conditions of testing (lighting etc.), product-born deficiency, and analytical test failures.
It remains to be seen if the first trends can be confirmed in the sequel of the study, and which test version(s) – referring to the „confidential reports“ - will be the most acceptable one(s) for the police demands in the context of roadside testing.
P
ASCAL
K
INTZ
, IMLS, F
RANCE
10:34 a.m.
In France, on-site testing is prohibited by different reasons: there are missing laws, and generally the police raise objections to the handling of the biological specimens. To be partner of the Rosita project, pharmacological criteria were investigated by comparing different biological specimens. The aim of the French study was the comparison in terms of positivity, practicability, rapidity, cost and scientific interpretation, because a documentation about the findings is needed toward judges.
The method: Over a period of nine months, 200 injured drivers (cars, motorcycles, cyclists, trucks) will be analysed, with a selection including subjects between 15 and 40 years (highest rate of drug consumption) that were admitted in an emergency unit in Strasbourg,. 10 ml blood (heparin) and 20 ml urine were collected in hospital. For saliva samples, Salivette
(Sarstedt) was used; for sweat, the forehead was wiped with a cosmetic pad (spiked with
500µl
50:50 isopropanol-water mixture).
In order to have a general overview for an epidemiological situation, blood was tested for alcohol (HS / GC / FID), amphetamines (GS-MS), opiates (GC-MS), buprenorphine (LC-
MS), cannabis (GC-MS), psychoactive drugs ( LC/DAD + GC-MS), cocaine (GC-MS). In urine, a screening by FPIA and EMIT (opiate, cannabis, cocaine, amphetamines, methadone, LSD) was performed with confirmation by GC-MS. Further the analysis of buprenorphine (LC-
MS) and psychoactive drugs (LC/DAD + GC-MS) was done.
For saliva and sweat it is not possible to organise a generalised screening based on the collected specimen. 1 ml could be gathered as a maximum for both specimens (in the French project is was written about 10 ml of saliva, which was not realisable). It was decided to test for the drugs in blood and urine due to the pharmacological acceptance. All sweat-pads were screened for cannabis because of the risk of external contamination (other drugs usually are not smoked, so an external contamination would be improbable).
It was assumed by P
ASCAL
K
INTZ
that a drug won’t be present in saliva, if it is not also present in at least blood or urine.

Because on-site tests are forbidden by the French law, in the laboratory the Rapid Drug Screen
(ABM), Syva Rapid Test (Dade Behring) and Dip Drugscan, Cortez (Pretor y) were evaluated by comparing FPIA and EMIT. As a first result, the most sensitive test seems to be the Rapid
Drug Screen (ABM) , (positive response 40 ng of codeine in urine). P.
K INTZ named related problems which can occur.
Most of the conflicting results - false positive, false negative – in confirmation with GC-MS were obtained with benzodiazepines.
A final total draft of the results will be presented after completion of the study.
About the situation on November 2, 1999:
173 from 200 cases have been evaluated, the possible end of the study might be December 1, the following presentation is based on 100 cases.
It was always possible to collect blood, urine was missing in 15 % of the cases. Sometimes it was difficult to obtain saliva in severely injured drivers, whereas sweat always was present, but this again includes the risk of external contamination.
Some of the results:
-
Cannabis
THC could be identified in 13 cases in blood with very low concentration between 0.4 -
5.4 ng/ml. 11-OH-THC was always present when THC was present (0.3 - 5.6 ng/ml). 15 cases of COOH-THC could be detected, but the subjects weren’t under influence any more
(17 - 813 ng/ml in urine).
By targeting only THC (impossible to analyse 11-OH-THC or COOH-THC in these specimens, even with GC-MS or MS-MS), the concentrations were very low: saliva (3-
103 (m=21) ng/salivette, n=8), sweat (4 - 152 ng/pad THC, n=13). An immunoassay should be able to find at least 5 ng/salivette (nearly 1 ml saliva - the salivette was directly extracted, not centrifuged) of THC. If this is not possible, there is no need to test for cannabis in saliva.
The question was asked if a subject - positive for COOH-THC in blood and urine, also positive in sweat but negative in saliva - is under influence.
It was pointed out how important it is to know for the judges, from which kind of specimen the results were gained.
-
-
Opiates
The concentrations in saliva are generally 2-5 times higher than in blood.
Amphetamines
In one case, drugs were found positive in urine (amp: 380 ng/ml; MDMA: 1806 ng/ml;
MDA: 432 ng/ml) and in saliva (AMP: 11 ng /saliv.; MDMA: 48 ng/saliv.), although blood was negative.
An equal case exists for norephedrine (blood: 162 ng/ml, urine: not available; saliva: 71 ng/saliv.; sweat: 16 ng/pad).
-
Other drugs
8 out of 100 cases were positive for benzodiazepines. The concentrations in saliva (< 20 ng/saliv.) and sweat (< 10 ng/pad) are very low, so a very sensitive immunoassay is necessary for the detection of BDZ.
Further phenytoine (18 mg/l), propoxyphene (0.11, 0.67 mg/l) and hydroxyzine ( 1.45 mg/l) could be found in blood.
On the basis of this pharmacological approach, P.
K
INTZ
drew the following conclusions:

-
-
-
-
Blood is specimen of choice
In saliva and sweat it is possible to find parent drugs in low concentrations, what can be particularly interesting for the identification of the drug, especially in cases with urine missing. But there also exists the risk of contamination
Apparently, cannabis is the major problem among young drivers. Cocaine, designer drugs and benzodiazepines are not frequent
The idea of using urinary kits for saliva or sweat is not applicable, at least for benzodiazepines and cannabis
There is an urgent need to propose a specific test for THC or CBN and CBD
-
COFFEE BREAK
DISCUSSION ABOUT WP4 (CONT.)
11:03 a.m.
P IRJO L ILLSUNDE , KTL, F INLAND 11:42 a.m.
Annually, the Finish police is doing about 2 million tests, mostly for breath alcohol, but also for drugs. Alcohol surely is the bigger problem, but this year already more drug cases exist than last year.
P
IRJO
L
ILLSUNDE
explained that in Finland a training program for police officers (adopted to the German training package and instructed by the ministry of Interior) started. Already about
200 policemen in Helsinki are trained and an enormous increase of drug recognition can be seen.
In the Rosita project it is planned to test 500 subjects on the occasion of random roadside controls. In order to get enough saliva samples, it was decided to include four cities into the study (the original purpose included three cities).
The demands of the police and the objections against saliva and urine were described, concerning the length of time (dry mouth), need of equipment (toilets) and the place of sampling (police station, clinic, laboratory). The police would prefer a drug testing device as easy as alcohol breath tests.
To the urine tests:
Cortez (Pretor y) was tested with good results, except for benzodiazepines; because pipetting in contrast to other tests is not necessary, there is a good acceptance by the police, but not for the roadside. Syva Rapid Cup (Dade Behring) were also tested with good results.
The Test Cup (Roche) was also tested, but the results aren’t confirmed yet.
About the saliva tests:
Until now, not many subjects exist: RapiScan (Cozart) , 27 cases, and Drugwipe (Securetec)
18 cases (with the electronic reader) were tested; the results are not confirmed yet.
In general, the urine test results will be confirmed via immunoassay, GC-MS, and TLC
(urine which is tested negative will also be analysed). Quantification is made by blood analysis.

P.
L
ILLSUNDE
remarked that presently another working group in Finland is working with clinical performance tests. The clinical test of performance shows nowadays better the symptoms of alcohol and benzodiazepines than the symptoms of other drugs. The purpose is to change the test patterns in order to show better the symptoms of other drugs as well.
G
IAMPIETRO
F
RISON
, CBFT, I
TALY
12:00 p.m.
In Italy, the Rosita project is realised by a co-operation of CBFT, the Highway Police NE Italy and the Italian Red Cross. An evaluation of on-site devices is practised on occasion of police checks. The total number of tested drivers should be 300, all on-site devices have been completed at the end of September ’99, however only 8 drivers could be analysed yet, but the screening and confirmation of laboratory analyses are in progress.
The protocol started in October `99 with ascertainments in some provinces of Veneto Region.
The samples:
For urine, Syva Rapid Test (Dade Behring) (300), Triage (Merck) (300) and Rapid Drug
Screen (ABM) (100, permanent place) were used. Saliva devices were taken with the
Drugwipe (Securetec) for cocaine, opiates and amphetamines (100 each), screening and confirmation of laboratory analyses were made on 50 samples.
The clinical data were made for correlation between on-site and laboratory results (screening and confirmation) on blood, urine and saliva.
The negative roadside-devices were not checked with GC-MS. The tests usually were accomplished by the police.
A
SBJORG
C
HRISTOPHERSEN
, NIFT, N
ORWAY
I
NGE
F
RYDENLUND
, O
SLO
P
OLICE
D
ISTRICT
, T
RAFFIC
D
EPARTMENT
12:12 p.m.
In this part of the WP-4 protocol, the utilisation of several on-site testing devices was analysed under roadside situation by the police.
I
NGE
F
RYDENLUND
compared the positive and negative features of the saliva devices
RapiScan (Cozart) and Drugwipe (Securetec) .
-
RapiScan (Cozart)
Positive: possibility to test for many types of drugs
Negative: easy determination of the final result
Much too complicated (too much chemist’s work, moistening of the pad with saliva) time aspect (sampling approx. 15 min., scanning 8-12 min ) scanner is sensitive to horizontal alignment, dust and humidity
-
Drugwipe (Securetec)
Positive: small size of equipment (suitable for operations on motorcycle)
easy way to take saliva samples
Negative: possibility to test one type of drug at a time.
Difficulty of reading the result

time aspect access of water is required problems by different temperatures higher risk to produce false results by applying too much force when pressing the test equipment together.
The general observation shows that measuring results seems to be doubtful, several police officers participating in the training sessions have tested positive. Scanning samples of saliva from the same person, the same sampling set have given different results.
Preliminary conclusions regarding usefulness of both types of equipment are the missing suitability for roadside use for Norwegian situations. Further, it should be available during major controls and for special vehicles, and the equipment may prove useful in testing suspect cases. The equipment may also be useful for testing persons brought to a police station.
Preferred instrument requirements would be: easy to handle, small and the test samples should be obtainable in a short time-span. Moreover, the test results should be available within the time-span required for controlling the driver’s licence and the vehicle registration paper, approx. 30 sec. The equipment should be conditioned robustly to sustain severe beating, a large temperature range dust and humidity.
I.
F
RYDENLUND
expected for the future having improved instruments with RapiScan (Cozart) possibilities for testing various drugs, and Drugwipe (Securetec) possibilities for easy sampling procedures.
C ALUM M ORRISON , FMS, UK
Two studies are existing in Scotland: a prison study and a police study:
-
12:40 p.m.
In the prison study, 200 saliva samples, up to 100 urine samples and as many blood samples as possible will be taken.
Participants will be prisoners and subjects from admission clinics. To get these 200 samples, 20 tests will be made each evening over 10 evenings. Surely it is a distance study from on-site testing and explains the high number of positive results.
Used test devices will be Test Cup (Roche), Syva Rapid Cup (Dade Behring), Cortez
(Pretor y), and others. Further GC-MS will be the reference method for blood and urine samples.
-
In the police study 120 samples in saliva and urine will be secured, but no blood will be taken. Participants are drivers under suspicion of impairment (a road-block will be set up by the police). In these cases the procedure will be started and samples collected.
The goals of these studies are as well testing the devices and also getting information about the public reaction and acceptance. The prisoners study was made above all with the intention of targeting a high number of cases.
LUNCH 12:55 p.m.

DISCUSSION ABOUT WP4 (CONT.)
M ANUEL L OPÉZ -R IVADULLA , USDC.IML, S PAIN 02:30 p.m.
In Spain, an agreement was made with the police about a protocol based on the Norwegian one, also an arrangement within the judicial system. The chief prosecutor gave permission to use the devices onsite, but in all cases the drivers were informed that the saliva tests are used for research purposes only and not in court.
The project includes 400 drivers to be tested: 300 drivers requested by the officers to do so as part of a program of prevention, 50 drivers were involved in accidents and 50 were involved in infractions or reckless driving. Participants were USDC.IML in co-operation with the police traffic group of Santiago the Compostela / La Coruña. The number of groups will be increased if necessary. The arrangements were made by the headquarters of the groups.
The roadside testing of saliva will be performed by police officers. 200 subjects with
RapiScan (Cozart) and Drugwipe (Securetec).
The devices will be distributed to the different police groups according to the number of cases expected in the corresponding areas. They will be selected randomly roadside and the distribution of the cases will take into account the following factors: accident black spots, to cover as wide a timetable as possible and different days of the week.
A protocol (designed at USDC.IML, based on NIFT and specified for the Rosita project) will be completed by the police for each driver tested. Following information will be included in the protocol: driver’s consent, police district, date and time, age and sex, type of devices, results from the preliminary testing.
In cases where a positive result is obtained, the person will be asked if he/she wishes to participate in the study, after which saliva, blood and urine samples will taken with his/her consent. The drivers will be informed that the results of these analyses will be used for research purposes only and not in court. If consent is given cocaine, opiates, cannabis, amphetamines and benzodiazepines will be tested for. In addition, saliva sample collection will be taken at the time of blood and urine sampling. The collected samples will be analysed at IML.USC using screening and confirmation procedures.
For the training, representatives from the participating police groups will be trained to use the test devices by project contractors and participants (USDC.IML / Securetec / Cozart).
The police officers will be responsible for further training of their colleagues at the districts with assistance from USDC.IML representatives, if necessary. These will participate with the police road-side during the early part of the testing period to clarify possible problems.
For all drivers testing positive, results from the clinical examination performed by physicians, will be studied.
The reason for stopping the subject (accident, infractions, reckless driving, routine control...) will be available for all of the cases from the standard protocols used. Results from saliva analyses (GC-MS) will be compared with results from saliva testing, blood and urine results and clinical examination.
Results from drug analyses in blood and urine samples and clinical examinations will be compared with results from device testing done by the police. The time between saliva testing at road side and blood / urine samples will be recorded.

A final evaluation by the police will include the following questions: usefulness, handling and registration of the test results, time necessary before test results are available and usefulness for evaluation of suspected drugged drivers.
The road side testing will start at the beginning of December 1999 and will finish at the beginning of March 2000.
END of the SCIENTIFIC PART of DAY 1 03:45 p.m.

th
Chairman: Alain Verstraete
PRESENTATION OF THE SMT-PROJECT 4-PL-97-3568: 11:15 a.m.
ON-SITE MEASUREMENT OF DRUGS OF ABUSE IN A SALIVA SAMPLE by
MARTIN
U
LLMAN
, E
NVITEC
,
GERMANY
The overall objective of this pre-competitive project is to develop a new immunochemical method for drug detection in a saliva sample according to SMT-Theme III 4. (Justice
System/Legal and Forensic Sciences). The intended drug screening test will also enable rapid and accurate detection of drugs at frontier traffic to the EC.
In a first step the proposers will focus their efforts on the simultaneous quantification of the five most prevalent drug classes (Cocaine, Amphetamine, Methamphetamine, Opiates,
Cannabis) in a sample volume of less than 0.5 ml. This innovation will be achieved by the joint exploitation of technologies in the unrelated fields of immunology, saliva diagnostics and analytical instrumentation. A European consortium consisting of 5 partners from 4 different European countries combines experts in these fields with considerable complementary expertise. Upon completion of the project the industrial partners will further exploit the technology by developing components ready to be used in series production of complete devices and accessory disposables for commercial distribution.
All reagents for the analysis of a sample will be contained in a specially designed, disposable polystyrol-cassette. A highly specific and sensitive immunochemical detection method
(EnzymeLinkedImmunoSorbentAssay) will be set up by the production of antibodies.
Reagents will be stabilised to ensure their integrity for at least one year under room temperature storage. The assay-method has to be optimised for the saliva matrix and for a later automatisation. Finally the user (police-officer) simply collects a sample and places it onto the device. Test-results shall be displayed quantitatively for each substance after 10 minutes at toxicological and legal relevant levels (for example as µg/L). The performance of the immunochemical method will be evaluated in comparison with a proven HPLC-method to ensure its accuracy, sensitivity, and specificity employing both standardised and real samples.
Along with the establishment of the immunochemical method a first laboratory prototype based on an existing biosensor-instrument will be realised by the prime proposer. This initial prototype has to undergo a field test by a police research institution with regard to its practicability, analytical soundness and suitability.
REPORT OF THE SAMSHA CONFERENCE (OCT. 5.-6. 1999): 11:25 a.m.
NON-INSTRUMENTAL-DRUG-TESTING-DEVICES by M
ICHAEL
W
ALSH
, USA
M
ICHAEL
W
ALSH
started with a historical overview concerning problems, obstacles and political circumstances in development of on-site testing in the last 15 years.

Over the last several years a request of the manufactures to a federal standard appeared to allow some of the new technologies (and further for on-site testing) by looking at all of the alternative major themes: hair, saliva and sweat. Working groups were created for the different topics (e.g. handling, transport etc.). These working groups comprise generally members who are best interested, because most of them are representing the manufacturing companies. The best product should be presented to the federal government.
M.
W ALSH explained that in terms of „on-site-testing“ devices would be a huge market because about 10% of the entire work force in the USA (of 100 millions) are covered by federal regulations that requires testing each year (at the moment done in the laboratories originally certified by NIDA) These labs are doing a volume of about 80 000 specimen per day, (probably only half the testing that is going on), where only 3 % are positive on the screen. By using on-site technologies, it would be possible to eliminate 97 % cases at the point of collection and decrease enormous costs and a lot of paper work. The dynamic at the work force and the changing of work places is making the capability of having rapid tests. But laboratoratories on the one (on-site testing devices would eliminate 97% of their business) and medical review officers on the other side (who collect 6 - 10$ per specimen, irrespective if it is positive of negative) don’t want to see this happen. They argue with e.g. a lower quality in on-site testing devices.
In the working group, two studies were made. The first study was heavily criticised because of the way it was designed; a second study evaluated most of the same devices with a few new ones (15 different devices plus a check strip to test for adulteration)
M.
W ALSH explained the accomplishment of this second study and named points to criticise, and that the study was not made for the general public, but for the US court: they had a 100 specimen and 90 specimens were spiked and there were 10 controlled, and 60 out of those 90 were within positive or negative 25 % to cut-off. By getting near to the cut-off level, the line begins to disappear and an interpretation is very difficult. The specimens were performed by laboratory technicians who were told to accomplish the test without a real training (only with package insert). Borderline results - whether positive or negative - were labelled as negative, this means a high number of false negative results.
In some analyses, some of the „ non-instrumental-drug-testing (NIDT)” devices performed better than the ETS instrumental devices. Looking at the specificity and sensitivity of drug analyses, there were significant differences across the tests, especially for THC.
It was shown that by shifting over to „on-site-testing“ by the criminal justice system from the state of California (about 50 000 tests per year, targeting especially people coming out of drug-treatment and where the taken drugs were known), significant reduction is seen in the number of specimen coming in the laboratories, in the terms of costs (by 25%) in spite of an increased testing (by 50 %). Over the last 3 years, several innovations were past of the contract purpose for the device, without having settled on any particular device.
The largest medical review officer program in the US has a new integrated on-site-system
(not yet available) which is described as a solid phase laminar flow monoclonal analyse that is build into the cup. For more information: E-Screen, 24 Corporal Woods 10895 Gradview
Suite 220 Orlando Park, Kansas 66210, voice 800-881-0722, fax 913-327-8606; Internet: www.escreen.net

M.
W ALSH gave two examples (drug testing by the US Postal Service, pre-trial rest testing by the Columbia criminal court system) and demonstrated that it is possible to get results much more quickly, that the systems are efficient and cost effective, and that an external quality control is necessary.
Adulteration checks in the US are becoming also very important. Concerning the Columbia criminal court system example, out of 219 specimen of that have been tested throughout 6 months, 2,2% adulterated were found.
There are following parameters of the adulteration check: Creatinine (>/= 20 mg/dl), Nitrite
(0 to trace amounts), Gluteraldehyde (0) and pH (4.0 - 9.0).
For more information of the 2-day-meeting : www.health.org
PRESENTATION ON: 12:15 p.m.
SALIVA TESTING AS SEEN FROM THE US by S
AM
N
IEDBALA
, STC T
ECHNOLOGIES
, USA
All together, S
AM
N
IEDBALA
accomplished three topics: First he concentrated on meetings and working groups in the US on alternative fluids. Then, he gave some data on addressing these issues, especially pointing out the role of saliva. Finally, he presented a technology for on-site testing that STC has developed.
Saliva testing in the US has been rocketing in the last few years, appearing in different market locations: the US department of transportation, insurance testing industry and limited workplace testing. It was distinguished between lab-based testing, and on-site (roadside) testing, and similarities between the testing in Europe and in the US were mentioned.
A few key points on saliva were given (e.g. the term “oral fluid” should be used rather than saliva, levels of cutoffs were established for screening and confirmation) and factors for reliable workplace testing were named (collection, collection device, specimen, collection procedure, analysis, confirmatory testing, QA/QC, reporting). S.
N
IEDBALA
suggested that in about three or more years the regulations in the US for workplace testing will be changed and that alternative fluids will come available.
To examine the question if morphine can be detected in oral fluid after the consumption of poppy seeds, the oral fluid of volunteers who consumed 40 grams of poppy seeds, and additionally poppy seeds themselves, were analysed by GC-MS. As a result in both cases
Morphine could be detected, but not 6-MAM. In contrast, in specimens gained from drug addicts who consumed opiates, 6-MAM can be seen; that makes a differentiation possible.
STC Technologies Inc. has developed a prototype for rapid drug testing for oral fluids, which utilizes a traditional lateral-flow technology with up-converting phosphor-technology, UPT
(infrared light excites phosphor particles, visible light is admitted; e.g. used in television technology). There are five bases: the sample collector, the test device including a visible QCwindow, a test strip in the device, the instrument including QC, and software. After the collection of an amount of 200 µl of oral fluid, the collector is delivered into the device, a button is pressed and the sample is analysed in 15 seconds. Then the test result comes upon a screen within 5 minutes. As key features for UPT, S.
N
IEDBALA listed: the possibility of multiple colours (several drugs can be seen simultaneously with individual signals), that there

is no background (the specimens can’t up-convert), permanent record (no fading), the support of miniaturisation, no interference, the suitability of the system for any matrix, and the high sensitivity (AMP, CAN, COC, LSD, OPI, PCP, METH can be found quantitatively to 1 ng/ml-level). AMP and MAMP can be separated.
With the examples Cannabinoids/THC and Cocaine/BZE, S.
N
IEDBALA demonstrated the measuring of samples with different drug concentrations, and it was pointed out that UPT will be equal to lab-based testing; screening cutoffs for MAMP of about 40 ng/ml, for COC
(BZE) of 10 ng/ml, for PCP of 3 ng/ml, for OPI (MOR) of 10 ng/ml, and for THC (parent) of
1 ng/ml are targeted by STC.
END of the SCIENTIFIC PART of DAY 2 12:45 p.m.