Healthy Adult Participants
Conditions
Keywords
Observational, Usability, IVD
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.
Interventions
DIAGNOSTIC_TESTDiagnostic procedures
Training in the use of the Intelligent Fingerprinting Drug Screening System.
DEVICEDrug Screening
Screening for drug use
Sponsors
Intelligent Bio Solutions Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 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
1. Is not able to read and communicate in English. 2. If, in the opinion of the Investigator, the subject is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operator Testing | 1 week | Usability testing of 15 operators, with training effectiveness assessed via 20 conformity to 20-task procedure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElan Cohen, PhD
CenExel HRI
Outcome results
None listed