Multi-drug Rapid Test Cup (Saliva)

Explain ：

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.

【PRINCIPLE】

The Rapid Response Drugs of Abuse Test Device detects Drugs of Abuse through visual interpretation of color development on the internal strip. Drug conjugates are immobilized on the test region of the membrane. During testing, the specimen reacts with antibodies conjugated to colored particles and precoated on the sample pad. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are insufficient drug molecules in the specimen, the antibody-colored particle conjugate will bind to the drug conjugates, forming a colored band at the test region of the membrane. Therefore, a colored band appears in the test region when the urine is negative for the drug. If drug molecules are present in the urine above the cut-off concentration of the test, they compete with the immobilized drug conjugate on the test region for limited antibody binding sites. This will prevent attachment of the antibody-colored particle conjugate to the test region. Therefore, the absence of a colored band at the test region indicates a positive result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

This test detects up to 23 combinations of the following drugs at the concentrations listed below. Specific combinations will vary according to the test in question:

The test is used to obtain visual qualitative result and is intended for health care professionals use including professionals at point of care sites to assist in the determination of drug compliance.

Bring tests, specimens to room temperature (15-30°C) before use. Avoid placing anything (including food, drink, gum and tobacco products) in mouth for at least 10 minutes prior to specimen collection.
* The oral fluid specimen should be collected using the collector provided with the kit. No other collection devices should be used with this assay.
* Instruct the donor to not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
* Bring tests, specimens to room temperature (15-30°C) before use.
* Using the provided collection Swab, donor should sweep inside of mouth (cheek, gums, tongue) several times, then the sponge will gradually soften as oral fluid is absorbed, and should be completely soft after 3 minutes. Important: Do not bite, suck, or chew on the sponge.
* Remove collection Swab from mouth and insert thesponge first into the screening cup, pushing until the locking flange locks in place in the bottom of the cup.
* The test cup should keepupright on flat surface while test is running. Wait for the colored bands to appear in test results
area. Read results at 10 minutes.

POSITIVE: Only one colored band appears, in the control region (C). No colored band appears in the test region (T) for the drug in question. A positive result indicates that the drug concentration exceeds the detectable level.

NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T) for the drug in question. A negative result indicates that the drug concentration is below the detectable level.

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.