Appendix; Dräger Drugtest 5000 Test Kit - Dräger DrugTest 5000 Technical Manual

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Appendix

9.1 Dräger DrugTest 5000 test kit
9.1.1 General remarks
The Dräger DrugTest 5000 test system uses test kits to collect
and analyse samples. Depending on the configuration of the
test kits, you can detect various substances or categories
(groups) of substances.
The DrugTest 5000 Analyzer recognises which test kit you are
using on the basis of information deposited in each test kit.
This information is used to make use of each test kit according
to its requirements and to evaluate the results of the analysis.
Beyond that, each test kit carries batch-specific calibration
data for the Analyzer and transfers them to the Analyzer prior
to evaluation. This ensures that all evaluations are performed
batch-independent without further action by the user and with
uniform quality.
This chapter contains universally applicable information on the
various test kits. You can find details on a specific test kit in the
respective Instructions for Use enclosed in the test kit pack.
9.1.2 Notices and precautions
NOTICE
i
i
The test kit can only be processed with the Dräger
DrugTest 5000 Analyzer!
The packing material of the test cassette must be completely
sealed. Do not use the test cassette if the seals are not intact.
In order to prevent the contamination of the sampler with
foreign bodies, open the package just prior to use.
Do not touch the sampler before and after sampling with bare
hands and observe usual hygiene precautions.
9.1.3 Compatibility of the Analyzer with new test kit
configurations
Different test kit configurations ("panel types") are available for
the Dräger DrugTest 5000 test system. A database integrated
into the Analyzer contains information on the available panel
types at the time of delivery.
When the range of panel types is enlarged, the Analyzer needs
to be updated before the new panel types can be used. See
"Configuration" on page 46.
Dräger DrugTest 5000 Testsystem
9.1.4 Test principle
The Dräger DrugTest 5000 test system is based on the
immunoassay principle of competitive inhibition. Drugs present
in the sample compete with drugs on the test membrane for the
cohesion of microparticles coated with antibodies.
Samples:
The various test kits have been evaluated for the respectively
indicated samples. The sample need not be specially treated.
The sample is absorbed directly into the porous sampler
integrated into the test cassette. The analysis is started after
sampling by placing both the test cassette and the cartridge
into the Analyzer. The Analyzer transfers the sample to the test
cassette and the test development is initiated automatically.
Test:
The sample interacts with the microparticles coated with
antibodies and with drug conjugates on the test membrane. If
the sample is devoid of drugs, the antibodies can react freely
with the drug conjugates and a signal is created on the test
membrane. If drugs are contained in the sample they link to the
microparticles coated with antibodies and as a consequence
the created signal is weaker. The Analyzer detects the signal
created by a specific sample and decides if the signal comes
from a preliminarily positive ("not negative") sample.
Quality control:
Each test membrane has another integrated sample-
independent antibody/antigen reaction. After the sample has
been processed successfully, antibodies on the reagent
membrane bind the antigens on the microparticles thus
creating a control signal. This signal is also detected by the
Analyzer and used to decide if a test is valid or not.
Data management:
Test results are stored in the Analyzer memory. All data can be
printed out. Additional details on the data management options
of the Analyzer can be found in chapter "Menu Data memory"
on page 45.
9.1.5 Storage and stability
Test cassettes and cartridges must be stored in the original foil
pouch at a temperature between 4 and 30 °C (39 to 86 °F). Do
not use test cassettes if the foil pouch is damaged.
The test cassette must be used immediately after you open the
foil pouch.
Do not use the test kit if the stamped use-by date has been
exceeded.
9.1.6 Scope of delivery
20 individually packaged test cassettes
20 cartridges
1 Instructions for Use
Appendix
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