Abstract
Objectives: This study evaluated the performance of NicAlert™ (Nymox Pharmaceutical Corporation) immunochromatographic strips for point-of-care (POC) nicotine testing of urine for pre-surgical qualification.
Methods: Performance was compared with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and enzyme immunoassay test (EIA) (Beckman Coulter AU5810). The predicted NicAlert™ reading and EIA results were calculated based on LC-MS/MS results and compared to measured results. The sensitivity and specificity were calculated.
Results: The NicAlert™ test strip had limited test performance (sensitivity=100%, specificity=40%) compared with EIA (sensitivity=100%, specificity=81%). In addition, the NicAlert™ tests had cross-reactivity to the metabolite, 3-OH-cotinine.
Conclusion: NicAlert™ test strips demonstrated high sensitivity for cotinine to assess recent tobacco exposure, due to the cross-reactivity with 3-OH-cotinine. This implies that recent nicotine exposure via passive, active, or chronic use, during the 6 weeks, will likely be detected by the NicAlert™ test strip.
Keywords
Cotinine, Nicotine, Point of care, Smoking, Pre-surgery qualification, Immunoassay, LC-MS/MS