Gima 24555 Manual De Uso página 9

The Multi-Drug One Step Multi-Line Screen Test Device (Oral Fluid) is an immunoassay based on the
principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against
their respective drug conjugate for binding sites on their specific antibody. During testing, a portion of
the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen
below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody
will then react with the drug-protein conjugate and a visible colored line will show up in the test line
region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid
specimen will saturate all the binding sites of the antibody. Therefore, the colored line will not form in
the test line region. A drug-positive oral fluid specimen will not generate a colored line in the specific
test line region of the strip because of drug competition, while a drug-negative oral fluid specimen will
generate a line in the test line region because of the absence of drug competition. To serve as a procedural
control, a colored line will always appear at the control line region, indicating that proper volume of
specimen has been added and membrane wicking has occurred.
Each test line in the test device contains mouse monoclonal antibody-coupled particles and corresponding
drug-protein conjugates. A goat antibody is employed in each control line.
• For medical and other professional in vitro diagnostic use only. Do not use after the expiration date.
• All specimens should be considered potentially biohazardous and handled in the same manner as an
infectious agent.
• The used collector and device should be discarded according to local regulations.
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test
device is stable through the expiration date printed on the sealed pouch. The test device must remain in
the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
The oral fluid specimen should be collected using the collector provided with the kit. Follow the
detailed Directions for Use below. No other collection devices should be used with this test. Oral fluid
collected at any time of the day may be used. If specimen cannot be tested immediately, it is recommended
that specimen be stored at 2-8°C or -20°C for up to 72 hours. Specimen may also be stored at room
temperature for up to 48 hours. For ideal shipment conditions, transport specimen using ice packs (2-
8°C).
• Test devices
• Security seals
• Timer
PRECAUTIONS
STORAGE AND STABILITY
SPECIMEN COLLECTION AND PREPARATION
MATERIALS
Materials Provided
• Collectors
• Package insert
Materials Required But Not Provided
PRINCIPLE
REAGENTS
• Collection tubes
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