Indications Use Statement for NicAlert®

Indications for Use

The NicAlert® test is for in vitro diagnostic professional use for the semi-quantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for NicAlert® is 1000 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert® Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert® test.