Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
研究概览
简要总结
Eligible subjects meeting the pathological profile will be recruited at the designated site by the study personnel. Following subject consent, the subjects will be evaluated for eligibility based on their health condition and history.
The ACR | U.S. kit, in its original packaging, along with the ACR | U.S. smartphone application will be provided to the subject in a simulated home- use environment. All subjects will be provided with a list of tasks to complete, including providing a urine sample and operating the ACR | U.S. device on 2 mobile phones. After completing the test, the lay user will complete a post-test questionnaire. The study observer will also complete a questionnaire to collect information regarding the lay users' use of the ACR | U.S.
The device use will be compared with identified risks to determine if the percentage of failures is acceptable. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
Following the usability test performed by the lay user, the subjects' urine samples will be tested by the study staff using the comparator device. These results will be considered as the "true value".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females 18-80 years of age.
- •Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
- •Diabetes Type I/Type II,
- •Hypertension,
- •any kidney disease,
- •other relevant conditions,
- •or, subjects who are healthy or pregnant.
- •Subject is familiar with the use of a smartphone.
- •Subject is capable of comprehending and following instructions in English.
- •Subject has facility with both hands.
- •Subject is capable and willing to adhere to the study procedures.
- •Subject is capable and willing to provide informed consent.
排除标准
- •Subject has dementia.
- •Subject has severe mental disorders.
- •Subject cannot collect urine in a receptacle.
- •Subject is visually impaired (cannot read the user manual).
- •Any additional reason the study physician believes disqualifies the subject from participating in the study.
结局指标
主要结局
Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
时间窗: 2 months
The primary objective of the study is to evaluate the % exact match (percent agreement) and the % ±1 block match (percent agreement) of ACR \| U.S. Urine Analysis Test System (tested by the lay user) compared to the URiSCAN Optima Urine Analyzer (the comparator device, tested by a healthcare professional user), for all reported values (blocks). Different concentrations reported by the ACR \| U.S. Urine Analysis Test System were compared with results from the comparator device.
次要结局
- Usability Evaluation: User Performance Analysis(2 months)