Intelligent Bio Solutions Inc.
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."
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…
Inclusion Criteria: 1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English. 2. \*Completed the screening process within 30 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures, provided all the required screening procedures have been perfor…
Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry
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