Product Overview; Intended Use; Explanation Of Symbols; Test Principle - Dräger DrugTest 5000 STK Instrucciones De Uso

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1 For your safety
1.1 Strictly follow the Instructions for Use
Any use of the Dräger DrugTest
understanding and strict observation of these instructions for use.
The components of the Dräger DrugTest 5000 STK are intended for
the prescribed use only.
2 Description
2.1

Product overview

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1 Cartridge
2 Safety cap
3 Sampler
4 Sample volume indicator
5 Housing with test strip
6 Sampler holder
Each packing unit contains:
• Dräger DrugTest 5000 STK, each packed in a sealed foil pouch.
The exact number is illustrated on the label on the packing unit.
Every foil pouch contains a pouch with desiccant and a Dräger
DrugTest 5000 STK, consisting of:
a. a test cassette with integrated sampler
b. a safety cap with cartridge
• Instructions for Use
2.1.1 Required materials that are not included
• Dräger DrugTest 5000 Analyzer (order no. 83 23 605) for
processing and analysis of the test cassettes.
2.1.2 Additional recommended materials
®
• Dräger DCD 5000 (order no. 83 19 910)
• Dräger Mobile Printer (order no. e.g. 83 19 310)
• Disposable gloves (e.g. latex or nitrile gloves)
2.2

Intended Use

NOTICE
i i
Not intended for medical use.
The Dräger DrugTest 5000 test system consists of the Dräger
DrugTest 5000 Analyzer and the Dräger DrugTest 5000 STK. The test
system is a point of collection test for the simultaneous, qualitative
detection of up to 8 analytes in human oral fluid samples for forensic
use.
Depending on the version, the Dräger DrugTest 5000 STK is designed
for the detection of influence by amphetamine, benzodiazepine,
cocaine, ketamine, methadone, methamphetamine, opiates and THC/
cannabis. Designer amphetamines (e.g. MDMA/Ecstasy) are also
detected by cross reactivities. The label on the packaging provides
information about the
DrugTest 5000 STK and the limit value (in ng/mL) for the specific
substance. The meaning of the abbreviations can be found in the
table.
Analyzers with firmware 2.0.0 or higher can process Dräger
DrugTest 5000 STK with various evaluation times if this option is
activated in the Analyzer. The evaluation time only influences the limit
value of THC: a short evaluation time increases the limit value, a long
1) Dräger DrugTest is a registered trademark of Dräger.
Dräger DrugTest 5000 STK
® 1)
5000 STK requires full
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present version of the
evaluation time reduces it. All other analytes are evaluated with the
same limit value regardless of the measurement mode.
If the Dräger DrugTest 5000 STK enables different evaluation times,
the label on the packaging also shows the limit value for THC in the
various measurement modes.
The Dräger DrugTest 5000 test system is a qualitative measurement
procedure. It provides information on the presence of the tested
substances in the sample above or below a limit value (cut-off) and
therefore only supplies a preliminary analytical result. To obtain a
confirmed analytical result, a more specific alternate chemical method
is needed. The preferred methods are GC/MS or LC/MS - see
Section 3.3 "Confirmation of results".
All the results of the Dräger DrugTest 5000 test system require
professional assessment with reference to further clinical assessment
of the test subjects. This is particularly applicable for a preliminary
positive result, see Table 1 (T1) on Page 19.
Depending on the configuration of the Dräger DrugTest 5000 STK, the
Dräger DrugTest 5000 test system can be used to confirm the
presence of the following drugs:
Drug (target analyte)
AMP Amphetamine (d-amphetamine sulfate)
BZO Benzodiazepines (Diazepam)
COC Cocaine (cocaine)
MET Methamphetamines (D-methamphetamine)
MTD Methadone (methadone)
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KET Ketamine (ketamine)
OPI Opiates (morphine)
00233267.eps
THC Tetrahydrocannabinol (∆9-THC)
2.3

Explanation of symbols

Strictly follow the Instructions for Use!
Manufacturer
Single use only
2
Batch
LOT
Temperature limit during storage
Expiry date
Contents sufficient for <n> tests
Measurement mode: fast (THC)
Measurement mode: sensitive (THC)
2.4

Test principle

The Dräger DrugTest 5000 test system is based on the immunoassay
principle of competitive inhibition. Drugs contained in the sample
compete with drugs on the test membrane for the cohesion of
microparticles coated with antibodies.
Sampling:
The Dräger DrugTest 5000 STK is designed for use with saliva
samples, which are taken with the integrated sampler.
The sample does not require special treatment. The sample is taken
directly by absorption into the sampler, which is integrated into the test
cassette. After sampling, the analysis is started by inserting the test
cassette and the cartridge into the Analyzer. The Analyzer transfers
the sample to the test cassette, where the test development is started.
Test:
The sample interacts with microparticles coated with antibodies and
Dräger
with drug conjugates on the test membrane. If the sample is drug-free,
the antibodies can react freely with the drug conjugates, which triggers
a signal on the test membrane. If the sample contains drugs, they bond
to the microparticles coated with antibodies, which weakens the
generated signal. The Analyzer detects the signal generated by a
specific sample and decides whether this signal originates from a
preliminary positive (non-negative) sample.
For your safety
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