INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Successful Interpretation of contrived devices
研究概览
简要总结
The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization [demonstration].
详细描述
The intent of this study was to collect data regarding the result interpretation of contrived results of INSTI HCV ST. The contrived test devices refers to mock test devices pre-made by bioLytical Laboratories Inc. Each contrived/mock test device was assigned to an ID number to be randomly provided to the participants.
Primary Objectives were to document and record the following:
•Successful interpretation of contrived test results using mock test devices (strong positive, weak positive, negative and a range of invalid results).
Depending on the device being evaluated participants received a contrived INSTI® HCV Antibody Self Test membrane unit.
Participants were asked to interpret "mock" results [read contrived device results using the reference chart in the Instructions for Use (IFU)].
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understands and sign the written informed Consent form
- •Able to complete the required testing on the allocated testing day[s]
- •Able to speak/read English
- •≥18 years of age
- •Provide a level of education (minimum grade 7)
排除标准
- •Does not meet the inclusion criteria
- •A practicing medical healthcare professional [doctor, nurse or counsellor that performs testing with Rapid Tests]
- •Has used blood-based RDT for self-testing previously, either HIV or HCV
- •Any condition which, in the opinion of the facilitator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of the mock result interpretation assessment, consent form and questionnaire etc. or bias the outcome
结局指标
主要结局
Successful Interpretation of contrived devices
时间窗: 3 Months
次要结局
未报告次要终点