Cotinine (COT) Rapid Test (Saliva)

Cotinine is the first-stage metabolite of nicotine, a toxic alkaloid that produces stimulation of the autonomic ganglia and central nervous system when in humans. Nicotine is a drug to which virtually every member of a tobacco-smoking society is exposed whether through direct contact or second-hand inhalation.  In addition to tobacco, nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal patches and nasal sprays. While cotinine is thought to be an inactive metabolite, it’s elimination profile is more stable than that of nicotine. As a result, cotinine is considered a good biological marker for determining nicotine use. The plasma half-life of nicotine is approximately 60 minutes following inhalation or parenteral administration.

TEST PROCEDURE

• Allow the test device, specimen, and/or controls to reach room temperature (15-30ºC) prior to testing. Donors should avoid placing anything (including food, drink, gum and tobacco products) in their mouth for at least 10 minutes prior to specimen collection.

  1. 1. Specimen collection:
  • Using the provided oral fluid swab, sweep the inside of the mouth for 3 minutes. The sponge will gradually soften as oral fluid is absorbed, and should be completely soft after 3 minutes
  • Stop sweeping the mouth, and push the moistened swab firmly into the specimen dispenser. Push the collector into the collection chamber and press down firmly to release as much liquid as possible. Be sure that at least 0.5 mL liquid has been collected in order to make re-confirmation test possible, if necessary.
  • Tightly shut the outer cap of the specimen dispenser.
• 2. Remove the test device from the sealed pouch and use it as soon as possible.
• 3. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of saliva(approx. 100ml) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below
• 4. Wait for the red line(s) to appear. The result should be read at 5 to 10 minutes. Do not interpret the result after 15minutes.
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• INTERPRETATION OF RESULTS
  

  (Please refer to the illustration)

  NEGATIVE:* Two lines appear. One red line should be in the control region (C), and another apparent red or pink line should be in the test region (T). This negative result indicates that the Cotinine concentration is below the detectable level

  *NOTE:  The shade of red in the test line region (T) may vary, but it should be considered negative whenever there is even a faint pink line.

  POSITIVE: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Cotinine concentration exceeds the detectable level (30 ng/mL).

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

  QUALITY CONTROL

  A procedural control is included in the test.  A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

  Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as good laboratory testing practice to confirm the test procedure and to verify proper test performance.

  LIMITATIONS
  

  1. 1. The Cotinine (COT) Rapid Test(Saliva) provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
  2. 2. It is possible that technical or procedural errors, as well as other interfering substances in the salivaspecimen may cause erroneous results.
  3. 3. Adulterants, such as bleach and/or alum, in salivaspecimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another saliva
  4. 4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in saliva.
  5. 5. A negative result may not necessarily indicate drug-free saliva. Negative results can be obtained when drug is present but below the cut-off level of the test.
  6. 6. Test does not distinguish between drugs of abuse and certain medications.
  7. 7. The test results can be used to provide evidence and basis for therapy and treatment plans of drug dependence and toxic psychosis. For laboratory professional in vitro diagnostic use only.
  8. 8. The test should only be performed by health professionals in a clinical/hospital setting to aid in screening of drug of abuse to determine the follow-up treatment measures in combination of clinical symptoms.
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