Performance Characteristics - Alere DDSV702 Instrucciones De Uso

Alere DDS V Test Kit
®

Performance characteristics

The Alere DDSV Test Kit is designed to have the following assay performance:
Under a controlled laboratory environment, a study was performed with at least three different lots of Alere DDSV Test
Kits and tested using drug-free oral fluid samples (0% cut-off) and drug-free oral fluid samples spiked at +100% of the
respective drug cut-off. The assay performance from this study are summarised in the table* below:
Sensitivity (drug-free oral fluid samples spiked at +100%) 99%
Specificity (drug-free oral fluid samples)
Accuracy (combination of sensitivity and specificity)
* Typical assay performance data; results in individual laboratories may vary from these data.
Cross reactivity
The following compounds show a negative response at 100,000 ng/mL. Concentrations that are highlighted are the
minimum concentrations which were found to give a positive result. The numbers in bold represent the cut-off concentration:
Codeine
Heroin
Morphine
MDA
Amphetamine
MDEA
Methamphetamine
MDMA
Cotinine
Amobarbital
Ranitidine
Amitriptyline
11-Hydroxy-Delta 9-THC
Delta 9-THC
11-Nor-9 Carboxy Delta 9-THC
Cocaine
Cocaethylene
Benzoylecgonine
Aspirin
Diazepam
Alprazolam
Temazepam
Methadone
EDDP
EMDP
LAAM
Dihydrocodeine HCL
Other drugs and drug metabolites that are not listed here may cause a positive result. Compounds for testing are under
constant review, please contact Product Support ([email protected]) for information on any drugs not listed.
5
Instructions for use | EN
AMP BZO
100,000 100,000
100,000 100,000
100,000 100,000
100 100,000
100,000
80
100,000 100,000
10,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 50
100,000 35
100,000
35
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
Sensitivity ≥ 90%
Specificity ≥ 99%
Accuracy
≥ 95%
AMP BZO
98%
100% 100%
100% 99%
COC
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100
75
30
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
COC MAMP MTD
95% 100% 98%
100% 100% 100%
98% 100% 99%
MAMP MTD
100,000 100,000
100,000 100,000
100,000 100,000
10,000 100,000
100,000 100,000
1,000 100,000
100,000
90
150 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 30
100,000 50,000
100,000 100,000
100,000 100,000
100,000 100,000
OPI THC
99% 100%
100% 100%
100% 100%
OPI THC
25 100,000
75 100,000
30 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 500
100,000 265
100,000 50
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
100,000 100,000
50 100,000