Description
Rapid test for the qualitative detection of cotinine (nicotine metabolite) in human urine.
For determining smoking status only.
Product not intended for medical or diagnostic purposes.
The test contains coupled mouse anti-cotinine monoclonal antibody particles and cotinine protein conjugate. A goat antibody is used in the control line system.

Precautions
- In vitro diagnostic device for individual use. Do not use beyond the expiry date.
- The test must remain in the sealed package until use.
- All samples are to be considered potentially dangerous and handled as infectious agents.
- Used tests must be disposed of in accordance with local legislation.

Sample collection and preparation
Urine Test: The urine sample should be collected in a clean, dry container. Urine collected at any time of the day may be used. Urine samples that show visible precipitates should be allowed to settle to obtain a clear sample for testing.

How to use
Bring the test and urine sample to room temperature (15-30°C) before testing.
1. Remove the test from the sealed package and use it within one hour.
2. Remove the cap.
3. With the arrow pointing toward the urine sample, immerse the test holder vertically into the urine sample for at least 10-15 seconds. Immerse the strip at least to the level indicated by the wavy lines, but do not touch the plastic holder.
4. Replace the cap and place the test holder on a flat, non-absorbent surface.
5. Start the timer and wait for the colored line(s) to appear.
6. The result should be read at 5 minutes. Results may remain stable for up to one hour after starting the test.

Interpretation of results
NEGATIVE*: Two lines appear. One colored line should be in the control region (C) and one colored line should be in the test region (T). A negative result indicates that the cotinine concentration is below the detectable level (200 ng/mL).
POSITIVE: A line appears in the control region (C). No line appears in the test region (T). A positive result indicates that the cotinine concentration exceeds the detection level (200 ng/mL).
NULL: No control line appears. Insufficient sample volume or incorrect procedural techniques are the most likely causes for a failed control line. Review the procedure and repeat the test with a new device. If the problem persists, discontinue use of the lot immediately and contact the distributor.
*The color shade in the test region (T) may vary, but it should be considered negative whenever even a faint colored line appears.

Limitations
1. The COT Rapid Test (Urine) provides only a preliminary qualitative analytical result. A secondary analytical method must be used to confirm the result. The recommended confirmatory method is gas chromatography/mass spectrometry (GC/MS).
2. Procedural technical errors may occur, as well as other substances in the urine sample interfering, causing erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
4. A positive result indicates the presence of cotinine or its metabolites but does not indicate the level of intoxication, the route of administration, or the concentration in urine.
5. A negative result does not necessarily indicate that the urine is free of cotinine. A negative result may occur when cotinine is present but below the cut-off level of the test.
6. The test does not distinguish between cotinine abuse and some drugs.

Conservation
Store in the sealed pouch at room temperature (2-30°C). The test is stable until the expiration date printed on the sealed pouch or on the closed container label. The test must remain in the sealed pouch or closed container until use. Do not use beyond the expiration date.

Format
Pack of 1 piece.