Usability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Operator Testing
Study Overview
Brief Summary
This is a prospective performance evaluation of usability of the Intelligent Fingerprinting Drug Screening System, conducted in clinic. The total number of healthy adult subjects (male and female) required for enrollment in this study protocol is 45: 15 operators and 30 donors (ideally two donors assigned to one operator). The total duration of the study, from check-in through the end of the study will be 2-4 hours for each donor subject.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Operators
"Operators" represent end users who utilize the screening system in an office or work setting. These subjects must have a minimum of high school education or equivalent. They do not have to possess special training in laboratory methods or medicine. No more than two-thirds (10 of 15) of operator subjects may be of the same sex (male or female). Operators will be trained in the use of the medical device.
Intervention: Diagnostic procedures (Diagnostic Test)
Donors
"Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening. Donors could include office workers, healthcare workers, technology professionals, train engineers, bus drivers, pilots, construction workers, truck drivers, manufacturing employees, food service workers, and equipment operators. No more than two-thirds (20 of 30) of donor subjects may be of the same sex (male or female). Donors will be tested with the IVD medical devices. Results will be contrived.
Intervention: Drug Screening (Device)
Outcomes
Primary Outcomes
Operator Testing
Time Frame: 1 week
Usability testing of 15 operators, with training effectiveness assessed via 20 conformity to 20-task procedure.
Secondary Outcomes
No secondary outcomes reported