Dräger DrugTest 5000 STK, Instructions For Use Manual, Page: 8 / 76

8 Dräger DrugTest 5000 STK
Limitations of procedure en
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.
As it is impossible to detect the possible influence of any food on the
test absolutely, comply with a waiting time of 10 minutes before
sampling.
7.2 Analytical performance
7.2.1 Analytical specificity
Most of the immunochemical detection reactions are not monospecific
for a single analyte, but they react to a group of analytes with a similar
chemical structure (e.g. the benzodiazepine test of the Dräger
DrugTest 5000 test system detects several different
benzodiazepines).
Therefore, it is not recommend that you use the results of a Dräger
DrugTest 5000 test system as a basis for (semi) quantitative
statements on the concentrations of one single analyte of a group of
analytes.
Data on the analytes which can be detected with the corresponding
test of the Dräger DrugTest 5000 test system, as well as data on the
individual concentrations which separately generate a positive result,
can be found in Table 1 ( T1 ) on page 72.
The analytes listed in Table 2 ( T2 ) on page 72 are not detected by the
Dräger DrugTest 5000 STK at concentrations below 10,000 ng/mL.
7.2.2 Repeatability
Reproducibility studies were conducted with commercially available
reference standards and negative saliva samples. Every saliva sample
was enriched with corresponding standards to maintain the desired
concentration of the analyte to be tested (no drugs, 250% limit value,
400% limit value. Every sample was tested at every analyte
concentration ten times on 3 different days with the same batch of the
Dräger DrugTest 5000 STK 6-Panel (8319830).
See Table 4 (
T4 ) on page 73 for the results of the study.
7.3 Diagnostic performance
To test the diagnostic performance of the DrugTest 5000 test system,
saliva samples were collected and analysed with the Dräger
DrugTest 5000 test system in a clinical environment. A second sample
was taken at the same time and tested by GC/MS or LC/MS. The
diagnostic performance of the Dräger DrugTest 5000 test system is
summarised in Table 3 ( T3 ) on page 73.
The specified clinical performance is based on tests with the specified
limit values.
8 Storage
Store the Dräger DrugTest 5000 STK b4 and +30°C. Do not
use the Dräger DrugTest 5000 STK if the foil pouch is damaged
(e.g. has a hole or is torn). Use the Dräger DrugTest 5000 STK
immediately after opening the foil pouch.
Do not use the Dräger DrugTest 5000 STK any more if the embossed
expiry date has passed.
9 Disposal
The Dräger DrugTest 5000 STK can be disposed of with normal
household rubbish.
10 Bibliography
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