Performance Features - Dräger DrugCheck 3000 Gebrauchsanweisung

Limitations of the procedure
6 Limitations of the procedure
The analytical features can deviate at the limit of the operating
temperature range. At temperatures below +10 °C, positive test results
must not be evaluated until 10 minutes after starting the
measurement. We recommend warming the test kit in your hands
before use.
Start the test kit between -5 °C and 5 °C as described in Section 3.2.2
and move it to a warm environment (e.g. a warm car). The test kit can
also be placed in its foil pouch and inserted upright in a jacket pocket.
Grip the foil pouch with the test kit inside with a warm hand to warm it
up. Read the test results 10 minutes after the measurement was
taken.
At temperatures over +35 °C and if there is a control line, positive test
results must be evaluated 3 minutes after starting the test.
Due to non-specific 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 DrugCheck 3000 have been
developed specifically for the detection of commonly abused
substances (drugs/drug types). For the user, this means for example
that the antibody reagents of the Dräger DrugCheck 3000 could react
with chemically similar substances such as prescription drugs or non-
prescription medicines and could result in false positive results.
The test has objectively detected the chemically related substance,
however in the confirming lab analysis, the corresponding commonly
abused substance cannot be proven.
To achieve a confirmed analytical result, an alternative lab process such
as GC-MS or LC-MS must be used. All the results of the Dräger
DrugCheck 3000 require professional assessment with reference to
further clinical assessment of the test subjects. This applies especially
for positive results.
The sampling process can be closely monitored. This means that
adulterating the sample is unlikely. However, if adulteration, dilution or
contamination of a sample is suspected, dispose of the sample and
repeat the test with a new Dräger DrugCheck 3000 test kit.
7

Performance features

7.1 Influence of food and beverages
Oral fluid may be contaminated immediately after consuming food,
beverages and/or sweets. To determine any influence of the
contamination on the results of the Dräger DrugCheck 3000, oral fluid
samples were taken and interpreted immediately after consuming
sample preparations:
cola, toothpaste, American cranberry juice, antiseptic mouthwash,
water, cough medicine (not containing codeine), coffee, chewing gum,
chocolate, fruit tea, herbal tea, cigarettes, orange juice, full fat milk,
cough drops containing menthol, mouthwash and tomatoes.
None of the interpretations yielded incorrect results.
As it is impossible to detect the potential influence of all foods on
the test, it is strongly recommended to observe a waiting time of
10 minutes before sampling.
10
7.2 Analytical features
7.2.1 Analytical specificity
Most of the immuno-chemical detection reactions are not monospecific
for a single analyte (drug) but they react to a group of analytes (drug
type) with a similar chemical structure (e.g. the opiate test of the Dräger
DrugCheck 3000 detects a number of different chemically related
opiates).
Therefore we do not recommend that you use the results of a Dräger
DrugCheck 3000 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
DrugCheck 3000 as well as data on the individual concentrations
which separately generate a positive result can be found in table 1 (T1)
on page 24. The analytes found in table 2 (T2) on page 24 are not
detected at concentrations below 10,000 ng/mL by the Dräger
DrugCheck 3000.
7.2.2 Repeatability
Reproducibility studies were conducted with commercially available
reference standards and negative oral fluid samples. Every oral fluid
sample was enriched with corresponding standards to maintain the
desired concentration of the test analytes (no drugs, 200 % limit value).
Every sample was tested at every analyte concentration ten times
over three different days with the same batch of the Dräger
DrugCheck 3000.
Correspondence with the expected test results was achieved in 100 %
of the cases.
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Dräger DrugCheck 3000