Evaluation of the Intelligent Fingerprinting Drug Screening System for Accuracy and Usability in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the Intelligent Fingerprinting Drug Screening System to compare its accuracy and usability against a standard laboratory test for detecting opiates in fingerprint sweat. The study involves healthy adult males and non-pregnant females aged 18 to 65. It aims to assess the sensitivity, specificity, and accuracy of this new drug screening method as well as how easy and consistent it is to use. The study includes two groups operators, who are trained adults using the screening system without drug administration, and donors, who are healthy adults randomized to receive either 0 mg, 30 mg, or 60 mg of codeine sulfate. The operators will be trained using guides and a training exam before conducting tests. Donors provide fingerprint sweat samples after dosing for analysis by both the new screening system and a laboratory method. Participants will provide fingerprint sweat specimens which will be tested and compared with laboratory analysis using liquid chromatographytandem mass spectrometry. The study will measure method comparison outcomes within 30 minutes to 3 hours and assess usability over 72 hours. Participants will be monitored for health status and follow-up assessments to measure the reproducibility and accuracy of the screening system throughout the study period.

Drug Screening System Method Comparison