Usability Evaluation of the Intelligent Fingerprinting Drug Screening System

15 adults, aged 18 to 65, male and female subjects. Each subject receives virtual training in the use of the Intelligent Fingerprinting Drug Testing System. Upon completion of training, each operator tests at least two (2) donors.

Thirty (30) additional subjects are recruited as donors. Donors provide fingerprint sweat specimens as instructed by operators.

For the 15 operator subjects, the in-clinic portion of the study will be four (4) to eight (8) hours. Operators will complete a combination virtual and hands-on training session. Upon completion of the training session, each operator subject will use the Intelligent Fingerprinting Drug Testing System to test two donor subjects. For one of the donor subjects, the screening cartridge will be coded to yield a non-negative result. This will prompt the operator subject to follow a different sequence of steps. The ability of the operator subject to use the system properly will be assessed by quantitative criteria.

Inclusion criteria

• 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.
• Completed the screening process within 30 days prior to enrollment. 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 performed within 30 days prior to enrollment.

Exclusion criteria

• Is not able to read and communicate in English.
• If, in the opinion of the Investigator, the subject is not suitable for the study.