Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System
95 healthy adults, male and non-pregnant female subjects. Each subject receives two doses of 60mg codeine sulfate in tablet form, the second dose four hours after the first. The first twenty subjects enrolled provide fingerprint sweat specimens for Sample Collection Cartridge stability evaluation. Each of the remaining 75 subjects provides fingerprint sweat specimens for evaluation of interference effects. These 75 subjects handle two interferents prior to providing fingerprint sweat specimens, both before and after receiving the codeine sulfate dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
95
Device will be stored prior to and following sample collection.
Interferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat.
CenExel New Jersey
Marlton, New Jersey, United States
Effect of Potential Interferents
The primary outcome of this study is to understand the impact of potential exogenous interferents on the Intelligent Fingerprinting Drug Screening System. Fluorescence measurement data from the fingerprint sweat screening method, along with LC-MS/MS data, will be analyzed post hoc to determine if any of the potential exogenous interferents has an appreciable effect on system results.
Time frame: For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection.
Stability of Confirmation Cartridge
Evaluation of the stability of the Sample Collection Cartridge, a component of the Intelligent Fingerprinting Drug Screening System in four aspects: 1) stability prior to fingerprint sweat collection, 2) stability after fingerprint sweat collection, 3) shipping stability prior to fingerprint sweat collection, and 4) shipping stability after fingerprint sweat collection.
Time frame: Up to three months following application of fingerprint sweat specimen
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