Precautions And Warnings; Test Procedures - Dräger DrugCheck 3000 IVD Mode D'emploi

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2.5

Precautions and warnings

NOTICE
i i
For hygiene reasons, use gloves when handling the Dräger
DrugCheck 3000. Do not touch the test cassette with bare
hands before and after sampling and follow the current
hygiene rules.
Follow proper handling and disposal procedures.

Open the foil pouch only immediately before use to prevent

contamination of the sampler.
Do not use the Dräger DrugCheck 3000 if the foil pouch is

damaged in any way.
Do not use the Dräger DrugCheck 3000 beyond the expiration

date on the foil pouch. The expiry date is in the format YYYY-MM.
Example: 2019-01 means that the Dräger DrugCheck 3000 is not
permitted to be used after the end of January 2019.
3 Testing
3.1 Preparing the test
NOTICE
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Results may be incorrect if maximum storage times are not
observed.
Ensure that the test subject has not eaten or drunk anything for at

least 10 minutes before sampling, e. g. chewing gum, tobacco,
coffee or other substances.
Ensure that the ambient temperature is between 5 °C and 40 °C

and the relative air humidity is between 5 % and 95 %.
Open the foil pouch.

Only remove the sample collector immediately before using the

test kit.
3.2

Test procedures

3.2.1 Collecting the sample
1. Remove the sample collector from the test kit (fig. 1) and hand to
the test subject.
2. Instruct the test subject to keep the sample collector in the cheek
pouches and move it carefully from one side of the mouth to the
other (fig. 2). This process takes approx. 15 seconds. If the red
colour indicator on the sample collector mouthpiece loses its
colour, the sampling process can be ended.
The test subject must not suck or chew on the sample collector!
3. Insert the sample collector into the funnel-shaped test opening in
the test cassette and press down as far as it will go to break the
ampoule (fig. 3). There must not be any gap between the sample
collector and test cassette.
3.2.2 Preparing and starting the test
4. Shake the test kit well until the red indicator ring has lost all colour
(fig. 4). This process takes at least 15 seconds. A small amount of
residual colour in the indicator does not affect the evaluation.
5. Place the test kit on an even surface (fig. 5) or hold upright in
your hand.
Depending on the required detection limit (cut-off) for the detection
of cannabis, the following waiting times (pre-incubation) must be
observed:
a. Measurement mode "sensitive" (THC)
Wait 60 seconds, then proceed.
b. Measurement mode "fast" (THC)
Wait 10 seconds, then proceed.
6. After the waiting time has elapsed, break the security seal on the
test kit and break off (fig. 6.1).
7. Push the test kit in an upright position at the sample collector
forcefully down to the limit stop (fig. 6.2) and tap the base lightly
on a flat surface (fig. 6.3). The saliva sample now flows out along
the test strip.
8. If the saliva sample does not flow along the test strip within one
minute, tap the base of the test kit on a flat surface again.
Continuously monitor the lines forming on the test strip.
Dräger DrugCheck 3000
4 Evaluation
4.1 Requirements for the evaluation
Ensure that the lighting is adequate when reading off the results
(e. g. daylight or torch).
4.2 Test results
Control lines
The control lines form in the top section C of the view window of the
test strip after starting the test.
Negative test result
Once test lines appear in the drug/drug classes area in the result
window and the control lines appear as well, the "negative" results can
be read off for the corresponding drug/drug class. This means there
are no drugs above the detection limit in the sample. The intensity of
the lines can vary, meaning that weak, partially coloured or broken
lines should also be evaluated as "negative".
Positive test result
If no red line appears in the drugs/drug classes area of the result
window for 5 minutes after starting the test, with a control line present,
this indicates a positive test result for this drug/drug class. This means
there are drugs above the detection limit in the sample.
Test valid/invalid
The test results must be evaluated within 10 minutes after starting the
test (for start time, see fig. 6.2). If the control lines do not appear on
one or both test strips within 10 minutes after the start time of the test,
the corresponding test strip must not be evaluated and is invalid. The
intensity of the control lines may vary. For this reason, only the
complete lack of a red line in area C of the result window for the
corresponding test strip is a sign of an invalid test.
Repeat the analysis if a statement is required on the invalid drug/drug
class.
Examples for the evaluation
(variant for 6 drugs/drug classes):
C C
MET AMP MET
THC OPI THC
BZO COC BZO
The test is valid and The test is valid and
negative. positive for opiates.
NOTICE
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With immuno-chemical tests, factors may occur that affect the
reliability. In rare cases this means that with a positive result
the test subject has not always actually consumed drugs
(false positive result). For this reason, a more comprehensive
confirmation analysis (e.g. GC-MS or LC-MS) is
recommended to confirm all positive test results.
See chapter 6 "Limitations of the procedure".
5 Quality control
Regular quality control is part of good analytical practice and may be
required by the relevant authorities. Always contact the responsible
authorising and accreditation bodies to ensure that the quality control
programme implemented corresponds to the applicable standards.
Internal control
An integrated process control is conducted with every analysis
(see also chapter 2.4 "Test principle"). If the operation has been
carried out without errors and the result can be reliably evaluated, the
control line forms in area C of the result window. If this line does not
appear, the test must be evaluated as invalid and not applicable. The
test should then be repeated.
External control
The features of the DrugCheck 3000 allow quality control to be run on
site by taking a drug-free sample and processing it. The result for all
drugs/drug classes must be negative in this case. When using positive
controls ensure that they are suitable for the Dräger DrugCheck 3000.
C C C
AMP MET
OPI THC
COC BZO
The test is only valid
for the left test strip
and it is negative.
The right test strip is
invalid.
Testing
C
AMP
OPI
COC
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