Interference and Stability Evaluation of the Intelligent Fingerprinting Drug Screening System

Conditions

• Illicit Drug Use
• Interference With Routine Analytical Tests
• Stability of in Vitro Diagnostic Reagents

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Device storage condition — DEVICE
  Device will be stored prior to and following sample collection.
• Interferent application — DEVICE
  Interferent will be applied to subjects' fingers prior to measurement of drug in fingerprint sweat.

Study Details

Prospective, open-label, double-dose, performance evaluation of interference effects and component stability of the Intelligent Fingerprinting Drug Screening System

Key Dates

First listed

Aug 11, 2026

Start date

Jun 15, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

95 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Other: Stability
  20 subjects. The fingerprint sweat sampling sequence for stability evaluation comprises two sequences. Each sequence begins with a codeine dose, an initial hand wash, and a fingerprint sweat specimen collection. The hand wash/sweat collection cycle is repeated three more times. The entire sequence is repeated for eight total specimens.
• Experimental: Interference
  75 subjects. Sampling comprises five time points of fingerprint sweat specimen collection for each of two interferents in the undosed conditions, and seven time points of fingerprint sweat specimen collection for each of two interferents in the dosed condition. The protocol allows for four additional sampling points during the dosed state for a total of 24-28 fingerprint sweat specimens. Baseline biological fluid sampling (fingerprint sweat) in the undosed condition will occur at 15-minute intervals following an initial hand wash, with repeat sampling. As in the undosed condition, several of the samples are preceded by the application of an interferent to the fingertips. If the initial screening test generates a non-negative result, continue the sequence of interferent application and fingerprint sweat sampling. If the initial screening test generates a negative result, wait 15 minutes and repeat. If the next screening test generates a negative result, wait 15 minutes and repeat.

Primary Outcome Measure

Effect of Potential Interferents [ Time Frame: For exogenous interferent contact within 15 minutes prior to fingerprint sweat specimen collection. ]

Locations (1)

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