One Step Cotinine Test Device

A rapid, one step test for the qualitative detection of Cotinine (nicotine metabolite) in human urine.
For determination of Smoking Status only.

Intended Use

The COT one step Cotinine test device (urine) is a lateral flow chromatographic immunoassay for the detection of Cotinine in human urine at a cut-off concentration of 200 ng/mL.

This assay provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography and mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Materials Provided

• Test device
• Dropper
• Package insert

Materials required but not provided

• Specimen Collection Container
• Timer

Directions for Use

The test device should remain in the sealed pouch until ready to use.
Allow test device, urine specimen to reach room temperature (15-30°C) prior to testing.

1. Bring pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface. Hold dropper vertically and transfer 3 full drops of urine (approx. 100 uL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
3. Wait for the colored line(s) to appear. The result should be read at 5 minutes. It is important that the background is clear before the result is read. Do not interpret the result after 10 minutes.

Interpretation of Results

(Please refer to the illustration above)

Negative:* Two lines appear. One colored line should be in the control line region ©, and another apparent colored line should be in the test line region (T). This negative result indicates that the Cotinine concentration is below the detectable level (200 ng/mL).
*Note: the shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint line.

Positive: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the Cotinine concentration exceeds the detectable level (200 ng/mL).

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely for control line failure. Review the procedure and repeat the test using a new test device. If the problem persists, discontinue using the lot immediately and contact your local distributor.