Operating Conditions; Interpretation Of Results; Performance Characteristics - Alere DDS 2 Manual Del Usuario

Alere DDS 2 Test Kit Instructions for Use | EN
®

Operating conditions

The operational temperature for running a test is between 5°C to 35°C. Test cartridges must not be at -5°C for
more than 10 minutes. Tests must be run in non-condensing humidity levels between 20 to 80%.
Cut-off levels
Drug Class Abbreviation
Amphetamine AMP
Benzodiazepines BZO
Cannabis (THC) THC
Cocaine metabolite COC
Methadone MTD
Methamphetamine MAMP
Opiates OPI

Interpretation of results

Interpretation is carried out by the Alere DDS2 Mobile Analyser, which will display either a negative, positive or lab
test required result for the drugs which have been tested.
Negative: This indicates that the drug concentration in the oral fluid sample is below the designated cut-off level
for that specific drug.
Positive/Lab test required: This indicates that the drug concentration in the oral fluid sample exceeds the
designated cut-off level for that specific drug.
Please note: Test result display can be selected by changing the analyser settings. Results can either be
displayed as positive/negative or lab test required/negative. Please refer to the Alere DDS2 Mobile Analyser
User Guide for information.
Limitations
1. This assay is for professional use only and provides a preliminary analytical test result.
2. Clinical and professional judgement must be applied in evaluating a preliminary positive or negative result.
3. Confirm positive results using a more specific alternative chemical method; GCMS or LCMS is preferred.
4. These results should not be used in isolation to change patient treatment or make a clinical decision.
5. It is possible that technical or procedural errors, as well as other interfering substances in the oral fluid sample
may cause erroneous results.
6. This assay is for the analysis of oral fluid samples only. Testing of inappropriate samples will not give valid results.
7. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication,
administration route or concentration in the oral fluid.
8. A negative result may not necessarily indicate drug-free oral fluid. Negative results can be obtained when a drug
is present but below the cut-off level of the test.
9. The test does not distinguish between drugs of abuse and certain medications.
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Target Drug Cut-off (ng/mL)
(S) Amphetamine 50
Temazepam 20
Δ THC 25
9
Benzoylecgonine 30
Methadone 15
(S) Methamphetamine 50
Morphine 40

Performance characteristics

The Alere DDS2 Test Kit is designed to have the following assay performance:
Sensitivity
Specificity
Accuracy
Under a controlled laboratory environment, a study was performed with at least three different lots of Alere DDS2
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%) 98%
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:
AMP BZO
Codeine 100,000 100,000
Heroin 100,000 100,000
Morphine 100,000 100,000
Dihydrocodeine HCl 100,000 100,000
MDA 100 100,000
(S) Amphetamine 50 100,000
(R) Amphetamine 5,000 100,000
(S) Methamphetamine 100,000 100,000
(R) Methamphetamine 100,000 100,000
MDMA 10,000 100,000
Cotinine 100,000 100,000
Amobarbital 100,000 100,000
Ranitidine 100,000 100,000
Amitriptyline 100,000 100,000
11-Hydroxy-Δ 9 -THC 100,000 100,000
Δ 9 -THC 100,000 100,000
11-Nor-9 Carboxy Δ -THC 100,000 100,000
9
Cocaine 100,000 100,000
Cocaethylene 100,000 100,000
Benzoylecgonine 100,000 100,000
Aspirin 100,000 100,000
Diazepam 100,000
Alprazolam 100,000
Temazepam 100,000
Methadone 100,000 100,000
EDDP 100,000 100,000
EMDP 100,000 100,000
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 (toxeu.productsupport@alere.com) for information
on any drugs not listed.
Alere DDS 2 Test Kit Instructions for Use
®
≥ 90%
≥ 99%
≥ 95%
AMP BZO COC MAMP MTD
92.1% 98.4% 96.6% 94.7%
100% 100% 100% 100% 100%
99.3% 97.3% 99.5% 98.9% 98.1%
COC MAMP MTD OPI
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 10,000 100,000 100,000
100,000 6,000 100,000 100,000
100,000 50,000 100,000 100,000
100,000 50 100,000 100,000
100,000 1,000 100,000 100,000
100,000 150 100,000 100,000
100,000 100,000 100,000 100,000
100,000 100,000 100,000 100,000
100,000 5,000 100,000 100,000
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
400 100,000 100,000 100,000
200 100,000 100,000 100,000
30 100,000 100,000 100,000
100,000 100,000 100,000 100,000
50 100,000 100,000 100,000 100,000
35 100,000 100,000 100,000 100,000
20 100,000 100,000 100,000 100,000
100,000 100,000 15 100,000
100,000 100,000 12,500 100,000
100,000 100,000 100,000 100,000
| EN
OPI THC
99.8% 91.3%
100% 100%
99.9% 97%
THC
25 100,000
75 100,000
40 100,000
50 100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
500
25
10
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
100,000
5