Analytical Performance; Analytical Specificity; Diagnostic Performance - Dräger DrugTest 5000 STK Instrucciones De Uso

en
As it is impossible to detect the possible influence of any food on the
test absolutely, comply with a waiting time of 10 minutes before
sampling.
7.2

Analytical performance

7.2.1

Analytical specificity

Most of the immunochemical detection reactions are not monospecific
for a single analyte, but they react to a group of analytes with a similar
chemical structure (e.g. the benzodiazepine test of the Dräger
DrugTest 5000 test system
benzodiazepines).
Therefore, it is not recommend that you use the results of a Dräger
DrugTest 5000 test system as a basis for (semi) quantitative
statements on the concentrations of one single analyte of a group of
analytes.
Data on the analytes which can be detected with the corresponding
test of the Dräger DrugTest 5000 test system, as well as data on the
individual concentrations which separately generate a positive result,
can be found in Table 1 (T1) on Page 19.
The analytes listed in Table 2 (T2) on Page 19 are not detected by the
Dräger DrugTest 5000 STK at concentrations below 10,000 ng/mL.
7.2.2 Repeatability
Reproducibility studies were conducted with commercially available
reference standards and negative saliva samples. Every saliva sample
was enriched with corresponding standards to maintain the desired
concentration of the analyte to be tested (no drugs, 250 % limit value,
400 % limit value. Every sample was tested at every analyte
concentration ten times on 3 different days with the same batch of the
Dräger DrugTest 5000 STK 6-Panel (8319830).
See Table 4 (T4) on Page 20 for the results of the study.
7.3

Diagnostic performance

To test the diagnostic performance of the DrugTest 5000 test system,
saliva samples were collected and analysed with the Dräger
DrugTest 5000 test system in a clinical environment. A second sample
was taken at the same time and tested by GC/MS or LC/MS. The
diagnostic performance of the Dräger DrugTest 5000 test system is
summarised in Table 3 (T3) on Page 20.
The specified clinical performance is based on tests with the specified
limit values.
8 Storage
Store the Dräger DrugTest 5000 STK between +4 and +30 °C. Do not
use the Dräger DrugTest 5000 STK if the foil pouch is damaged
(e.g. has a hole or is torn). Use the Dräger DrugTest 5000 STK
immediately after opening the foil pouch.
Do not use the Dräger DrugTest 5000 STK any more if the embossed
expiry date has passed.
9 Disposal
The Dräger DrugTest 5000 STK can be disposed of with normal
household rubbish.
10 Bibliography
1. Wille S, Samyn N, del Mar Ramirez-Fernandez M, GDe Boeck G
(2010). Evaluation of on-site oral fluid screening using Drugwipe-
5+, RapidSTAT and Drug Test 5000 for the detection of drugs of
abuse in drivers. Forensic Sci Int, 198(1-3):2-6.
2. DRUID Workpackage 3.1.1 (2009). Evaluation of oral fluid
Screening devices by TISPOL to Harmonise European police
Requirements.http://www.druid-project.eu
3. DRUID Workpackage 3.2.2 (2010). Analytical evaluation of oral
fluid screening devices and preceding selection procedures.
http://www.druid-project.eu
4. Cone E.J. (2001). Legal, workplace, and treatment drug testing
with alternative biological matrices on a global scale. Forensic Sci
Int, 121:7.
5. Yacoubian G.S., Wish E.D., and Perez D.M. (2001). A comparison
of saliva testing to urinalysis in an arrestee population. J of
Psychoactive Drugs, 33:289.
6. Niedbala R.S., Kardos K.W., Fritch D.F., Kardos S., Fries T., and
Waga J. (2001). Detection of marijuana use by oral fluid and urine
analysis following single-dose administration of smoked and oral
marijuana. J Anal Toxicol, 25:289.
7. Caplan Y.H. and Goldberger B.A. (2001). Alternative specimens
for workplace drug testing. J Anal Toxicol, 25:396.
8. Cone E.J., Oyler J., et al. (1997). Cocaine Disposition in Saliva
Following Intravenous, Intranasal, and Smoked Administration. J
Anal Toxicol, 21:465.
Dräger DrugTest 5000 STK
detects several different
9. Samyn N., Verstraete A., van Haeren C., and Kintz P. (1999).
Analysis of drugs of abuse in saliva, Forensic Sci Rev, 11:1.
10. Hawks R.L. (1982). The constituents of cannabis and the
disposition and metabolism of cannabinoids. In Hawks RL (Ed):
The Analysis of Cannabinoids in Biological Fluids, NIDA Research
Monograph Series 42; U.S. Government Printing Office;
Washington, DC; p. 125.
11. Jenkins A.J., Oyler J.M., and Cone E.J. (1995). Comparison of
heroin and cocaine concentrations in saliva with concentrations in
blood and plasma. J Anal Toxicol, 19:359.
12. Jenkins A.J. (1998). Detecting Drugs of Abuse in Saliva. Ther
Drug Monit and Toxicol 19:3.
13. O'Neal C.L., Crouch D.J., et al. (1999) Correlation of Saliva
Codeine Concentrations with Plasma Concentrations After Oral
Codeine Administration. J Anal Toxicol, 23:452.
14. CDC (1987) Universal Precautions for Prevention of Transmission
of HIV and Other Bloodborne Infections. MMWR 1988,37:377-
388.
Storage
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