Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Lay user / laboratory test result concordance
研究概览
简要总结
This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.
详细描述
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). 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, around 50 million people per year are living with HCV, resulting in 244,000 deaths. The WHO estimates that only 36% 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.
The Panbio™ HCV Self Test, is a lateral flow test, designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood. The test is designed to be used by lay users and uses a sample volume of 10 µL. The professional use version test (Bioline™ HCV Test) is commercially available and has previously been clinically validated by the manufacturer, demonstrating a sensitivity of 99.3-100% and a specificity of 98.1-100%.
Evaluation of the test performance when used by professional users has been conducted, and evaluation of lay user sensitivity and specificity based on lay user populations outside the EU is being conducted. This study will demonstrate the test performance and usability of the test when used in a European lay user population. The study will be conducted at one recruiting hospital in Spain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Participant is aged 18 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 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.
结局指标
主要结局
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.
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.
次要结局
- Labelling comprehension evaluation(5 months)
- Lay user / professional user results interpretation concordance(5 months)
- Results interpretation evaluation(5 months)
- Usability evaluation - Self-test observer records(5 months)
- Usability evaluation - lay user experience(5 months)