Precautions And Warnings; Test Procedures; Quality Control - Dräger DrugTest 5000 STK Notice D'utilisation

Testing

Quality control:

An additional antibody and antigen reaction independent of the sample
is integrated into every test membrane. When the sample has been
successfully processed, antibodies on the reagent membrane bond to
the antigens on the microparticles and generate a control signal. The
Analyzer also detects this signal and it is used to decide whether the
test is valid or not valid.
2.5

Precautions and warnings

NOTICE
i i
For hygienic reasons, use gloves when handling the Dräger
DrugTest 5000 test system and all samples. Do not touch
the sampler with bare hands before and after sampling and
observe 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 DrugTest 5000 STK if the foil pouch is
damaged.
• Do not use the Dräger DrugTest 5000 STK beyond the expiry date
printed or embossed on the pouch. The expiry date is formatted as
YYYY-MM, e.g. 2020-01 means the Dräger DrugTest 5000 STK
should not be used after the end of January 2020.
• The Dräger DrugTest 5000 STK can be processed only with the
Dräger DrugTest 5000 Analyzer.
3 Testing
3.1 Test preparation and sampling
• Ensure that the test subject has not had any substances like
e.g. food, chewing gum or tobacco in the mouth for at least
10 minutes before sampling.
• Make sure that the ambient temperature is between +5 °C to
+40 °C / +41 °F to +104 °F and the relative air humidity is between
5 % and 95 % relative humidity.
• Make sure that the packaged test cartridges are at ambient
temperature (wait for 15 minutes to achieve temperature
equalisation if necessary).
1. Remove the safety cap with cartridge from the sampler of the test
cassette (Fig. 1) and give the test cassette to the test subject.
Keep the safety cap with cartridge.
2. Instruct the test subject to place the sampler in the cheek and
move it carefully from one side of the mouth to the other (Fig. 2).
The test subject must not chew or suck on the sampler.
Watch the sampling process!
• A sufficient sample will be collected within 4 minutes. If the sample
volume indicator shows blue before the 4 minutes have passed,
the sampling can be ended (Fig. 3).
If the sample is not analysed immediately after it has been taken, make
sure to follow the instructions in Section 3.1.1 "Delayed analysis".
3.1.1 Delayed analysis
NOTICE
i i
Results may be invalid or incorrect if maximum storage
times are not observed.
If the saliva is not analysed immediately after the sample has been
taken, the Dräger DrugTest 5000 STK can be stored at room
temperature up to a max. of 4 hours (confirmation of THC) or 8 hours
(confirmation of all other drugs). The safety cap must be placed back
onto the sampler holder in this case. Remove the safety cap from the
sampler holder again before analysis.
3.2

Test procedures

NOTICE
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Observe the Instructions for use of the
Dräger DrugTest 5000 Analyzer.
3. Take the test cassette with the sample from the test subject.
Open the Analyzer door and insert the test cassette into the
bottom slot of the Analyzer until it audibly clicks into position
(Fig. 4).
4. Remove the cartridge from the safety cap and insert the cartridge
into the top slot of the Analyzer until it audibly clicks into position
(Fig. 5).
5. Close the door
The Analyzer automatically starts the analysis.
8
On completion of the analysis, the Analyzer displays the results for
every tested substance on the screen.
Note the display.
6. Remove the test cassette with the cartridge after the analysis and
dispose of it (Fig. 6).
3.3 Confirmation of results
The Dräger DrugTest 5000 test system is a qualitative measurement
procedure. For a confirmed result, a second sample must be taken and
analysed by an accredited laboratory.
Take the second sample with a collection system suitable for saliva
®
samples (e.g. Dräger DCD 5000 (order no. 83 19 910)).
4 Interpretation of results
On completion of the analysis, the Analyzer displays the results for
every tested substance on the screen. See the Instructions for Use for
additional details on the operation of the Analyzer.
Data management
After the analysis, the test results are shown on the Analyzer display
and saved in the Analyzer memory. All data can be printed out with the
Dräger Mobile Printer. For more information on the data management
options of the Analyzer see the Technical Manual for the Dräger
2)
DrugTest 5000 test system .
5 Quality control
Regular quality control is part of a good analytical practice and may be
required by the responsible authority. Always contact the responsible
authorising and accreditation bodies to ensure that the applied quality
control programme corresponds to the applicable standards.
Internal control
An integrated process control is conducted with every analysis (see
also Section 2.4 "Test principle"). If the analysis was run without errors
and the result safe to interpret, a control signal is generated. If the
control signal is not generated, the Analyzer does not interpret the
analyses but shows "invalid" as the result. Depending on the
configuration, the Analyzer display may differ if a result is invalid
(e.g. "not interpretable").
External control
The properties of the test allow a quality control to be run on site by
taking a drug-free sample and processing it. The result for all analyses
of this sample must be "negative".
When using positive controls, ensure that they are suitable for the
Dräger DrugTest 5000. For information on suitable positive controls,
please contact DrägerService
6 Limitations of procedure
Due to unspecific interactions (physiological deviation, state of health
or sample contamination), false positive or false negative results may
occur in rare cases.
The antibodies used in the Dräger DrugTest 5000 test system are
specifically adjusted to drugs. Nevertheless, structurally similar
prescribed and over-the-counter drugs can react with the antibody
reagents and cause false positive results. To achieve a confirmed
analytical result, a more exact, alternative chemical method like GC/
MS or LC/MS/MS has to be used. 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 important for a preliminary positive result.
The sampling process can be closely monitored. This means that
faking the sample is improbable. However, if faking or substitution of a
sample is suspected, dispose of the sample and repeat the test with a
new Dräger DrugTest 5000 STK.
7 Performance features
7.1 Influence of food and beverages
Saliva may be contaminated immediately after consuming food,
beverages or stimulants. To determine any influence of such
contamination on the results of the Dräger DrugTest 5000, saliva
samples were taken and interpreted immediately after consuming the
following sample preparations:
Coke, toothpaste, American cranberry juice, aseptic mouthwash,
orange juice, water, cough syrup (without codeine), coffee, chewing
gum, chocolate, fruit tea, herb tea and cigarettes.
None of the evaluations yielded incorrect results.
2) The Technical Manual can be downloaded free of charge from the Dräger
home page (www.draeger.com).
®
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Dräger DrugTest 5000 STK
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