Intended Use - Alere DDSV702 Instrucciones De Uso

Alere DDS
™
Instructions for Use
Important: Please read these INSTRUCTIONS for USE in full before using the Alere DDSV Test Kit. Please
refer to the description on the packaging of the Test Cartridge for the specific details of the drug panel in
use.
Kit Contents
Each box of test kits contains sufficient material for 25 tests and one Instruction for Use insert.
Each individual Alere DDSV Test Kit contains:
1 x DDS V702 or DDS V703 Test Cartridge
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1 x Alere DDS Collection Swab
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1 x Alere DDS Run Buffer (1.8mL containing methanol)
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1 x Sample Buffer Flip Top Lid
1 x Windicator

Intended use

The Alere DDSV Test Kit is intended for the collection and testing of oral fluid for the detection for the presence of drugs
of abuse and/or their metabolites. For professional in vitro use only.
A positive test result should be confirmed by a second test method such as GCMS (gas chromatography-mass
spectrometry) or LCMS (liquid chromatography-mass spectrometry).
Principles of the test
The sample flows by capillary action along the test strip, carrying with it labelled anti-drug antibody. At designated zones
on the strip, drug protein conjugate has been applied in bands which become visible to the human eye. In the absence
of a drug in the sample, the anti-drug antibody will bind to the drug protein conjugate to form a line. In the presence of a
drug the formation of this complex will be diminished, forming a weaker line. A procedural control is included in the Test
Cartridge which confirms sufficient sample volume, adequate membrane wicking and correct procedural technique. The
absence of a line in the control position will indicate the test results are invalid. The test result will be visually interpreted by
the test kit operator following the instructions provided.
Storage and stability of reagents
Store all contents at 15°C to 25°C. Do not freeze. The reagents are stable until the expiry date indicated on the packaging.
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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V Test Kit
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