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Description
Multi-drug Rapid Test Device（Saliva)
INTENDED USE
The Multi-drug Rapid Test Cup (Saliva) is a rapid visual immunoassay for the qualitative detection of drugs of abuse in human oral fluid specimens.This test detects up to 19 combinations of the following drugs at the concentrations listed below. Specific combinations will vary according to the test.
PRINCIPLE
The Multi-drug Rapid Test Cup (Saliva) 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.
COMPOSIITION
Individually packed screening cups
Package insert
Oral fluid collection swabs
STORAGE AND STABILITY
The kit should be stored at 4-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Do not freeze.
Kits should be kept out of direct sunlight.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can
