For Your Safety; Product Overview; Instructions For Use; Intended Use - Dräger DrugCheck 3000 IVD Mode D'emploi

For your safety

1 For your safety
1.1 Follow the Instructions for Use
Any use of the Dräger DrugCheck
understanding and strict observation of these Instructions for Use.
The components of the Dräger DrugCheck 3000 are only intended for
the described use.
2 Description
2.1

Product overview

Dräger DrugCheck 3000 Test Kit (fig. A)
1 Sample collector with colour indicator
2 Test cassette with indicator ring
3 Funnel-shaped test opening
4 Security seal
5 result window with test strip
Result window with test strip (fig. B)
6 Control line area (C)
7 Test line area (MET, AMP, THC, BZO, OPI, COC)
Each packing unit contains:
20 x Dräger DrugCheck 3000 test kits, each packed in a sealed

foil pouch
1 x Instructions for Use

The Dräger DrugCheck 3000 test kit consists of 2 components:
the test cassette and the sample collector
The removable sample collector has a red colour indicator to display
sufficient sampling.
The test cassette contains an ampoule with buffer solution, a red
coloured indicator ring for handling control, as well as 2 test strips with
2 control lines (C) and up to 6 strips for the various drugs/drug classes,
depending on the product variant.
Additional recommended material
Disposable gloves (e. g. latex or nitrile gloves)

Timer

2.2

Intended use

The Dräger DrugCheck 3000 is a point of collection test for the
simultaneous detection of up to 6 drugs/drug classes (depending on
the product variant) in human oral fluid for diagnostic purposes (in-vitro
diagnostic device) and/or forensic use. These drugs/drug classes are
cocaine, opiate, amphetamine, methamphetamine, THC/cannabis and
benzodiazepine. Each drug/drug class is represented by a separate
test line on one of the test strips in the result window on the test
cassette.
The Dräger DrugCheck 3000
information on the drugs/drug classes with their abbreviations (see
also the table on "2.2.1"), detection limits (in ng/mL), shelf life and
storage conditions.
The detection limit (cut-off) is the deciding factor regarding the
presence of the drugs/drug classes in the sample. The test result is
correspondingly positive or negative above or below the limit value.
To obtain a confirmed analytical result a more specific method must be
used. The preferred method is the liquid or gas chromatography/mass
spectrometry (GC-MS or LC-MS). All the results from the Dräger
DrugCheck 3000 require professional assessment with reference to
further clinical evaluation of the test subjects. This applies in particular
to a positive ("not negative") test result, see also table 1 (T1) on
page 92.
1) Dräger DrugCheck is a registered trademark of Dräger.
8
® 1)
3000 requires complete
packaging gives all important
2.2.1 Drug (target analyte)
Drug
AMP Amphetamine
BZO Benzodiazepine
COC Cocaine
MET Methamphetamine
OPI Opiates
THC Tetrahydrocannabinol
2.3

Explanation of symbols

Strictly follow the Instructions for Use!
Manufacturer
In-vitro diagnostic medical product
IVD
Batch
LOT
Temperature limitation
Expiry date
Contents sufficient for <n> tests
Measurement mode: fast (THC)
Measurement mode: sensitive (THC)
2.4

Test principle

The Dräger DrugCheck 3000 is based on the immunoassay principle
of competitive inhibition. Drugs contained in the sample compete with
drugs on the test membrane for the binding of nanoparticles coated
with antibodies.
Sampling:
The Dräger DrugCheck 3000 is designed for use with saliva samples,
which are taken with the integrated sampler.
The sample does not require special treatment. The sample is
collected directly into the sample collector via absorption. The sample
collector is then inserted into the funnel-shaped test opening in the test
cassette to perform the test.
Test:
The fluid sample is then rinsed in the buffer solution by shaking. After
waiting for the pre-incubation time to elapse, the test can be started by
breaking the security seal and pressing the sample collector
downwards with the test cassette.
Gold particles coated with antibodies react with drug molecules from
the fluid sample and during the course of the test with drug conjugates
on the test membrane. If the sample is drug-free, the antibodies can
react freely with the drug conjugates, forming a red line on the
test strip. If the drug is available in sufficient concentration, the gold
particles are impeded from adhering to the drug conjugate. If the
sample is preliminarily positive ('not negative'), no test line will appear
in the area for the corresponding drug in the test strip result window.
Quality control:
An additional antibody/antigen reaction independent of the fluid
sample is integrated into every test membrane. When the Dräger
DrugCheck 3000 has successfully processed the sample, the control
antibodies on the reagent membrane bond to the control antigens.
In this case, a red line forms in area C in the result window of the
corresponding test strip.
en
Target analyte
D-Amphetamine
Diazepam
Cocaine
D-Methylamphetamine
Morphine
∆9-Tetrahydrocannabinol
Dräger DrugCheck 3000