NCT06618183

Drug Screening System Method Comparison

User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison and Usability

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: Intelligent Bio Solutions Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Prospective, open-label, single-dose, randomized, multi-site performance evaluation of the accuracy and usability Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."

Detailed description

This study will compare positive and negative test results obtained from fingerprint sweat using the Intelligent Fingerprinting DSC-7 Drug Screening Cartridge versus opiates in sweat collected via the Fingerprint Collection Kit for Laboratory Analysis, within healthy males and non-pregnant females. The primary objective is to compare the sensitivity, specificity, and accuracy of the Intelligent Fingerprinting Drug Screening System to the validated confirmatory LC-MS/MS technique. The secondary objectives are to assess drug screening system usability and reproducibility. "Operators" comprise nine (9) adults: male and female subjects who operate the drug screening system. These subjects are not administered any drug. "Operators" represent end users who utilize the screening system in a laboratory setting. "Operators" will be provided the Intelligent Fingerprinting Drug Screening Guide, Confirmatory Laboratory Analysis Guide, and Quick Reference Guide, and be trained in system use. After receiving and reviewing all materials, the "operator" will complete a Training Exam to determine if he or she may proceed with testing. "Donors" comprise 135 healthy adults: male and non-pregnant female subjects who provide fingerprint sweat specimens. Subjects will be randomized into the blocks administered 0, 30, or 60mg of codeine sulfate in tablet form. "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening.

Conditions

• Reagent Kits, Diagnostic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fingerprint sweat drug screen	Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
DIAGNOSTIC_TEST	Fingerprint sweat laboratory analysis	Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry

Timeline

• Start date: 2024-08-26
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study