OraSure Test Cutoffs Urine Serum Oral Fluid Type of Exposure 500ng/mL 25ng/mL 10ng/mL. Second-Hand Smoke <100 ng/ml <15 ng/ml <3 ng/ml

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2 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, Attorney 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. 2 For over 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. 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 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 OraSure Test Cutoffs Urine Serum Oral Fluid Type of Exposure 500ng/mL 25ng/mL 10ng/mL Second-Hand Smoke <100 ng/ml <15 ng/ml <3 ng/ml Light Smoking ng/ml ng/ml 3-33 ng/ml Regular Smoking >500 ng/ml >100 ng/ml >33 ng/ml 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

3 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 chainof-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.

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5 RedPlanetTesting.com

6 RedPlanetTesting.com