Multi-drug Rapid Test Panel (Urine)

Explain ：

The Multi-drug Rapid test Panel (Urine) is rapid chromatographic immunoassays for the qualitative and simultaneous detection up to sixteen of the following drugs in a variety of combinations in human urine.

【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.

The designed cutoff concentrations for these drugs are as follows:

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.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
2. Remove the cap from the end of the test card, and immerse the strip(s) of the test card vertically in the urine specimen for at least 10-15 seconds. Do not touch the plastic device when immersing the panel.
3. Place the test card on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not interpret results after 8 minutes.

POSITIVE:Only one colored band appears in the control region (C).No apparent colored band appears in the test region (T).
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).
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.
NOTE:
1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen.Therefore, any shade of color in the test region should be considered negative. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.