OraSure Lab-based Saliva Cotinine Test

Tobacco use is the single most preventable cause of disease, disability, and death in the United States with an estimated 443,000 premature deaths each year – another 8.6 million people live with serious illness caused by smoking.1

In 1984, Surgeon General C. Everett Koop presented the first of a series of reports revealing the health consequences of tobacco use including involuntary exposure. While the United States has not overcome the challenges of the the “smoke-free” society that Koop hoped for by the year 2000, industries across the country now recognize the importance of testing.

For over 20 years, OraSure Technologies has offered a wide range of tobacco (cotinine) testing products for multiple specimen types and 20 years, OraSure Technologies has offered a wide range of tobacco (cotinine) testing products for multiple specimen types and thus is well qualified to meet today’s challenges.

OraSure Lab-based Saliva Cotinine Test will give you an exact measurement of cotinine which you can access on an Internet system 24/7.

shelf life of 15-18 months

 1. Why test for cotinine and not nicotine?
Cotinine is the first-stage metabolite of nicotine. Because the window of detection for nicotine is relatively short (approximately 2 hours), cotinine extends the window of detection for several days and is the preferred method of screening for tobacco use.3

2. Which sample types can be tested for cotinine?
OraSure manufactures laboratory-based cotinine tests for urine, serum and oral fluid samples. Concentrations will vary depending on sample type but each provide comparable positive rates. For oral fluid testing, oral fluid is collected with the OraSure® Oral Specimen Collection Device and screened by the laboratory with our corresponding test.

3. Will a second-hand smoke exposure produce a positive result?
No. In numerous studies, cotinine detection levels have been examined across specimen types and exposure rates for passive exposure. Cotinine tests have been clinically designed to accomodate for the minute traces commonly found from second-hand exposure when compared to levels found in smokers. The cutoff value of these tests are set by OraSure to properly distinguish passive exposure from true smokers. Below are some common examples of testing outcomes:4-6

 As you’ll note, the lower concentration of second-hand smoke is well below the test cutoff, and therefore would not be reported as a positive. In addition, urine tests are typically much higher than serum or oral fluid as a result of the higher concentrations of cotinine found in urine. However, the positive rates across sample types remains relatively similar.7

 4. Can the cotinine level be used to determine the type and volume of tobacco used?
No. While it’s true that the more a person smokes, the higher the cotinine level is likely to be, a number of contributing factors influence testing outcomes such as:
• Size of the individual
• Percentage of body fat present
• Rate of metabolism
• Hydration state of the individual
• Type of cigarette/cigar/pipe smoked or tobacco chewed
• Smoking style
• Elapsed time from smoking to testing
• The pH of the urine (if urine testing is conducted)

5. What practices or other substances may be used that could generate a positive cotinine test result?
Certain cultures found in India or Asia are known to chew and ingest betelnuts. The preparation of this product is commonly mixed with tobacco producing a positive cotinine test result.8 Additionally, certain vegetables contain small concentrations of nicotine like eggplant or tomatoes. Only copious amounts consumed could trigger a cotinine positive test result.3 Finally, cotinine may also be found amongst tobacco workers who strip the tobacco leaves from their stalks. Absorption through the skin can produce a positive result even if the worker does not in fact smoke. There are a few other examples where a positive result may occur from a non-smoker but theses circumstances are very rare. Investigation of the individual’s lifestyle or occupation typically uncovers these anomalies.

6. Which testing method is the most accurate?
The different cutoffs in the three test types generate similar sensitivity and specificity for the cotinine tests with similar windows of detection. The better question to ask is which method best suits my testing purposes. If a flexible, non-invasive format is what you need for your testing program, then the OraSure® Oral Fluid Specimen Collection Device offers the same performance as our urine and serum tests while providing optimal versatility in the cotinine testing industries.

7. How is the sample collected?
The donor controls his or her own sample under direct visual supervision. The “collector” really is an observer and not in the “chain-of- custody” – the process most often legally challenged. If the donor wants to challenge the collection, the only person to challenge is the donor. The entire process can be completed anytime – anywhere and takes just minutes to administer.

8. What is the stability of the sample and how is it shipped?
Specimens stored in the Oral Fluid Specimen Vial may be kept at 39ºF to 98ºF for up to 21 days (including the time for shipping and testing). Shipping of the specimen is generally done via overnight courier as part of your arrangement with the laboratory.

 9. How is the sample analyzed?
Oral fluid samples are screened in a certified laboratory using the OraSure® MICRO-PLATE tests which use enzyme immunoassay technology (EIA), proven reliable for routine cotinine testing. Studies have shown that there is good agreement between test results and confirmation testing by gas chromatography/mass spectrometry (GC/MS or GC/MS/MS). Your laboratory can help you set up confirmation strategies in accordance with your testing policy.

10. What is the detection window for oral fluid?
Just like traditional urine drug testing, the window in oral fluid testing is similar for cotinine. What we have found is that oral fluid screening identifies recent usage that can be missed by urine testing. Oral fluid samples provide a close match to drug levels in blood, identifying donors that are under the influence at the time the sample is collected. Since the OraSure® testing system detects the nicotine metabolite, the window of detection in oral fluid starts almost immediately after tobacco use and can last up to about three days.

11. Can oral fluid be adulterated?
OraSure Technologies has studied a wide range of compounds and techniques available today, and has not identified any that can alter the results of the test. Furthermore, the risk of the donor introducing any compound into the vial is highly unlikely since every collection is directly and easily observed. These facts will cut all costs associated with adulterant and dilution testing common with urine testing.

12. What are the economic advantages of using oral fluid?
Oral fluid drug testing, with its “anywhere / anytime” collection process, results in significantly lower costs associated with collections, scheduling fees, and lost time on the job. Oral fluid collections reduce the labor costs for gender-specific collectors and shy-bladder syndrome (can’t go), and eliminate dilution testing – all of which contribute to the higher costs of urine testing.

13. How soon can you expect your results?
The lab receives samples via overnight courier. Testing is performed the day samples arrive and positive or negative results are reported within 24 hours. Should confirmation testing be required, an additional 24 to 48 hours should be expected.

14. Is oral fluid a biohazard?
No. OSHA does not consider oral fluid collection hazardous. In addition, oral fluid specimens are not subject to the same handling and disposal procedures that are issues with other bodily fluids.

15. Who uses OraSure?
Millions of OraSure® Collection Devices have been utilized nationally and internationally by large and small organizations over the past 20 years. These include insurance companies for insurance risk assessment, hospitals and businesses for health and wellness programs, as well as companies conducting research or clinical trial applicant evaluations.

16. How is training done?
Test administrators can be trained and certified in about an hour by our OraSure sales and technical staff. This can be done by phone, in person, or with a webbased training class.

17. Who is OraSure Technologies?
OraSure has a 20-year legacy of offering accurate and precise enzyme immunoassay (EIA) products for laboratory testing. We have a long history of meeting the needs of the substance abuse testing industry. Our team of scientists pioneered oral fluid testing and has led the industry with innovative and cost-effective solutions. OraSure manufactures and sells products for testing drugs, alcohol, Flu, HIV, and HCV.