The Abbott Diagnostics iScreen OFD - Cotinine test device is a rapid, oral fluid screening test that can be performed without the use of an instrument. The test utilizes antibodies to selectively detect elevated levels of specific cotinine in human oral fluid.
The iScreen oral fluid nicotine test instantly screens for cotinine and is ideal for smoking cessation programs and employee screening and health wellness programs.
One end of the device has a collection swab used to collect the oral fluid sample. The collector actively swabs the mouth and tongue until saturated with saliva, then inserts the collector into the cap and locks it into place. The collector then lays the device on a horizontal surface to allow the test results to develop.
Results are read at ten minutes. The presence of a line at the test indicator is a negative result. The absence of a line indicates recent tobacco use. The integrated internal control assures the operator that the test worked correctly. In addition, the iScreen nicotine test makes laboratory confirmation of non-negative results simple. The operator places a tamper evident seal over the cap of the device, and sends the entire device to the laboratory.
The Alere iScreen oral fluid nicotine test accurately screens for cotinine, the primary metabolite of nicotine. A cut-off level of 30 ng/mL level allows the device to detect cotinine up to 1-2 days and longer after nicotine use.
Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. It is produced when the body metabolizes nicotine after ingestion. Cotinine is used as a biomarker for exposure to tobacco and is typically detectable for several days after the use of tobacco.
iScreen OFD has been cleared by the U.S. FDA as substantially equivalent to the lab-based saliva test currently employed for workplace testing. Analysis of known cotinine-positive and know cotinine-negative saliva sample showed 97.6% sensitivity (ability for the test to correctly identify positive specimens) and >99% specificity (ability for the test to correctly identify negative specimens). By comparison, the lab-based saliva test showed 90.5% sensitivity and 98.0% specificity.
The level of cotinine required to trigger a positive results (30ng/mL) would require a significant exposure to Second Hand Smoke (SHS) and is high enough to eliminate most potential false positive from SHS.
An increasing number of employers are choosing to implement randomized nicotine testing in an effort to discourage dishonesty when a premium differential, incentive, or tobacco surcharge is implemented. In states where the law allows it, nicotine testing may also be used by companies who have a no-hire policy for tobacco users.
Professional, trained staff members can conveniently administer the tests at the worksite and obtain results within 10 minutes. Each test comes with detailed instructions.
When an employee tests positive for cotinine, we refer to it as a "presumptive positive". To verify the result, a confirmation test may be required by law when employment decisions are being made, and is recommended if the test is being used to determine eligibility for insurance premiums.