Usability Evaluation of the Intelligent Fingerprinting(TM) Drug Screening System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Operator Testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Is not able to read and communicate in English.
- •If, in the opinion of the Investigator, the subject is not suitable for the study.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Drug Screening (Device)
结局指标
主要结局
Operator Testing
时间窗: 1 week
Usability testing of 15 operators, with training effectiveness assessed via 20 conformity to 20-task procedure.
次要结局
未报告次要终点