Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,185
- 主要终点
- Lay user / professional user test result concordance
研究概览
简要总结
This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).
详细描述
Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.
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
- Single (Outcomes Assessor)
盲法说明
The study staff member who interprets the lay user's result will be blinded to the lay user's reference test results and medical status. The study staff member who conducts the Panbio™ HCV Self Test for the lay user will also be blinded to the lay user's reference test results and medical status as well as the self-test results.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is aged 14 or over
- •Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.
排除标准
- •Participant has already participated in this study on a previous occasion.
- •Participant is aware of their HCV status
- •Participant is deemed unfit for the study by the Investigator.
- •Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
- •Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
- •Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
- •Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
- •Participant is unwilling or unable to provide informed consent.
- •Participant has participated in the study "Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation".
结局指标
主要结局
Lay user / professional user test result concordance
时间窗: 5 months
To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test.
Lay user / laboratory test result concordance
时间窗: 5 months
To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples.
次要结局
- Usability evaluation - lay user experience(5 months)
- Usability evaluation - Self-test observer records(5 months)
- Lay user / professional user results interpretation concordance(5 months)