NICOTINE/COTININE (COT) One-Step Rapid Drug Screen Test Device (cassette type) An Easy, Forensic in vitro Diagnostic Test for use in the Qualitative Detection of Cotinine (Nicotine metabolite) in Human Urine at a Minimum Sensitivity Cut-off Level of 200 ng/ml Cotinine (COT) Established as Standard by the U.S. Department of Health and Human Services, DOT, World Health Organization and SAMHSA. For the Rapid Forensic Determination of Smoking Status, Tobacco or Tobacco Product Use Only. Not intended to diagnose a medical condition or disease.

INTENDED USE

The One-Step Rapid Nicotine (COT) Test is a lateral flow, one-step immunoassay for the qualitative detection of Cotinine, the principle metabolite of nicotine, in human urine at a cut-off sensitivity level of 200 ng/ml. Cotinine is a principle and residual metabolite of Nicotine which remains in the body of habitual tobacco users. The test is intended for forensic, non-diagnostic use only to determine tobacco or nicotine use.
This test is used to obtain a visual, qualitative result of tobacco use and is for the determination of smoking status and/or tobacco/nicotine use only. This test is not intended to diagnose any medical condition or aliment. For forensic use only.

SUMMARY

Most experts and healthcare professionals agree that nicotine is unquestionably the most addictive drug in use today. The principle source of nicotine is tobacco products. Tobacco smoking or chewing results in the absorption of nicotine through the lung and buccal/nasal epithelium, after which nicotine is metabolized into 20 metabolites excreted in urine. Cotinine, a major metabolite of nicotine accumulates in the body with regular smoking. It is reported that Cotinine is stable in body fluids and has a relatively long half-life of approximately 17 hours. Therefore the detection of Cotinine is less dependent on the time of sampling than that of nicotine and other metabolites. Cotinine has been widely used as a bio-marker of tobacco exposure. Methods of analysis for Cotinine in biological fluids include gas chromatography, gas chromatography-mass spectrometry, HPLC, HPLC-mass spectrometry, EIA and RIA. These methods usually require special equipment and complicated operation procedures. For comprehensive information on drug testing including typical half-life or drug detection periods see the Drug Testing FAQ.

The One-Step Rapid Nicotine Test is a one step immunoassay that is used for the qualitative detection of Cotinine in human urine. It is based on the principle of highly specific immunochemical reactions of antigens and antibodies. It is a simple and convenient test for the rapid qualitative detection of Cotinine in human urine at 200 ng/ml cut-off concentration.

PRINCIPLE

The One-Step Rapid Nicotine Test applies the principle of competitive immunoassay. The test device contains a membrane strip that is pre-coated with Cotinine antigen at the test line region. The Cotinine antibody gold conjugate pad is placed at the end of the membrane. In Cotinine-free urine, the colored antibody-colloidal gold conjugate and urine moves chromatographically by capillary action across the membrane. This solution migrates to the test line containing Cotinine antigen and forms a visible line as the antibody complexes with the antigen. The formation of a visible precipitant in the test zone indicates a negative result (non-smoker). When Cotinine is present in urine, it competes with Cotinine on the test band region for the limited antibody sites. When a sufficient concentration of Cotinine is present in urine, it will compete at the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate at the test line region. Therefore, absence of the color band on the test region indicates a positive result (smoker).

A different antigen/antibody reaction is added to the membrane strip at the control region (C) to indicate that the test has been performed properly. This control line should always appear, regardless of the Cotinine status in the urine. This means that negative urine will have two pink colored bands, and positive urine will have only one pink colored band. The pink colored control band serves as an indicator that 1) sufficient volume has been added, and 2) that proper flow was obtained.

MATERIALS SUPPLIED

Individually sealed test device which includes one disposable pipette each and complete instruction sheet with test technology, inter-reaction and cross-reaction data.

ASSAY PROCEDURE

• Refrigerated specimens or other materials should be equilibrated to room temperature before testing

• Open the foil pouch at the notch, remove the test device, and label the device with specimen ID.

• Holding the dropper vertically as shown, add 3 drops of urine into the sample well "S" or until the well is full.

• Positive results may be observed as soon as 3 minutes, depending on the concentration of the Cotinine in the tested specimen. To confirm negative results, a complete reaction time of 3-4 minutes is required. Do not interpret results after 5 minutes.

INTERPRETATION OF TEST RESULTS:

Positive One (1) pink-rose band appears in the control zone and no band appears in the test zone. A positive result indicates the Cotinine level is 200 ng/ml or higher in the test urine sample.
Negative One band appears in the test zone and one band appears in the control zone. A negative result indicates that the Cotinine level is below the detection sensitivity of 200 ng/ml. IMPORTANT: any line, no matter how faint, appearing in the test area confirms a negative test.
Invalid If there are no distinct color bands visible in both the test zone and the control zone or if there is a visible band in the test zone but not in the control zone, then the test is invalid. In this instance, re-testing of the specimen is recommended.

TEST AVAILABILITY

The One-Step Rapid Nicotine (COT) Test is available to professionals and individuals concerned with tobacco use/abuse. The test is compact, self-contained, individually packaged and can be performed any time the targeted drug use is suspected. The tests come in minimum order units of five (5) individual tests at a cost per single test screen of $4.50 for the minimum order unit.

Test Description/Type	Quantity	Cost	Order
One-Step Nicotine/Cotinine (COT) Cassette Test	Five (5) Tests	$22.50
	Fifteen (15) Tests	$55.00
	Thirty (30) Tests	$90.00
	One Hundred (100) Tests	$225.00
	Two Hundred Fifty (250) Tests	$475.00
	Five Hundred (500) Tests	$825.00
*If the order buttons are absent or inoperable, please use the pricing overview page to order.

Urine Sample Validity and Adulteration Test Strips are available: Adulteration Test

Professional specimen collection containers available separately: Specimen Containers