T3 - Clinical Performance - Dräger DrugTest 5000 STK Instrucciones De Uso

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
20
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
Dräger DrugTest 5000 STK
>26
71
1
>390
22
0