T3 – Clinical Performance
Cocaine
Cocaine-Equivalents
Dräger DrugTest 5000
<14
positive
negative
98
Agreement: 97.5 %
GC-MS Cut-off: 14.0 ng/mL
Opiates
Morphin-Equivalents
Dräger DrugTest 5000
<14
positive
negative
89
Agreement: 95.2 %
GC-MS Cut-off: 14.0 ng/mL
Benzodiazepine
Diazepam-Equivalents
Dräger DrugTest 5000
<10.5
positive
negative
86
Agreement: 95.4 %
GC-MS Cut-off: 10.5 ng/mL
Tetrahydrocannabinol
Delta-9-Tetrahydrocannabinol
Dräger DrugTest 5000
<3.5
positive
negative
63
Agreement: 92.6 %
GC-MS Cut-off: 3.5 ng/mL
Amphetamine
Amphetamine-Equivalents
Dräger DrugTest 5000
<35
positive
negative
93
*
data comprise clinical and spiked samples
Agreement: 95.0 %
GC-MS Cut-off: 35.0 ng/mL
Methamphetamine
Methamphetamine-Equivalents
Dräger DrugTest 5000
<24.5
positive
negative
90
*
data comprise clinical and spiked samples
Agreement: 98.4 %
GC-MS Cut-off: 24.5 ng/mL
Dräger DrugTest 5000 STK
Reference Sample contains
[ng/mL]
14 – 20
20 – 26
0
1
0
1
0
Reference Sample contains
[ng/mL]
14 – 20
20 – 26
3
4
0
2
0
Reference Sample contains
[ng/mL]
10.5 – 15 15 – 19.5
2
1
1
2
0
Reference Sample contains
[ng/mL]
3.5 – 5
5 – 6.5
0
0
0
1
0
Reference Sample contains
*
[ng/mL]
35 – 50
50 – 65
1
1
10
5
0
Reference Sample contains
*
[ng/mL]
24.5 – 35 35 – 45.5
0
8
10
2
0
Methadone
Methadone-Equivalents
Dräger DrugTest 5000
positive
>26
negative
20
Agreement: 97.1 %
2
Ketamin
Katamin-Equivalents
Dräger DrugTest 5000
positive
>26
negative
27
*
data comprise clinical and spiked samples
1
Agreement: 87.3 %
This Test-Kit is manufactured using proprietary technology created by
Epitomics Inc. USA.
T4 - Reproducibility
>19.5
16
Date
Batch/Result
1
08/08/2008
ARZH-0061: No positives at 0 %, no negatives at
250 % and 400 %.
18/08/2008
ARZH-0061: No positives at 0 %, no negatives at
250 % and 400 %
ARZH-0061: No positives at 0 %, no negatives at
21/08/2008
250 % and 400 %.
>6.5
25
6
>65
9
0
>45.5
13
0
Reference Sample contains
[ng/mL]
<14
14 – 20
20 – 26
3
1
0
60
0
0
GC-MS Cut-off: 14.0 ng/mL
Reference Sample contains
*
[ng/mL]
<210
210 – 300 300 – 390
2
9
4
68
10
3
GC-MS Cut-off: 210.0 ng/mL
>26
71
1
>390
22
0
73