Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Proportion of patients with SARS-CoV-2 infection
研究概览
简要总结
This study is envisaged to evaluate the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralized healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
详细描述
Project Title: Evaluation of molecular point-of-care Xpert® Xpress SARS-CoV-2 detection implementation in resource limited settings (RIA2020EF-2990) - EXPERT-CoV-2
Principal Investigator: Dr Daniel T. R Minja, NIMR- Tanga Centre, Korogwe Research Station, Tanzania
Collaborating Partners: University of Kinshasa, DR Congo, Research Institute for Health Sciences, Burkina Faso, University of Copenhagen, Denmark, Univesity of Antwerp, Belgium, University of valencia, Spain
Background. Rapid diagnostic tests of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are the cornerstone to implement early case detection and management to control the spread of the deadly virus. RT-PCR is the gold standard for detection of SARS-CoV-2 but its availability and userability is impeded by fragmented laboratory infrastructure in LMICs and even when available it's only found in reference labs.
Recent development of the Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test , Cepheid Sunnyvale, CA) for SARS-CoV-2 testing in the clinics with results delivery within hours of sample collection has been vital in resolving the turnaround time (TAT). GeneXpert have been widely rolled out within national tuberculosis (TB) and HIV programmes across the Africa. However, evaluation of its diagnostic accuracy and the feasibility of its integration into the TB/HIV programme has not been evaluated in resource-constrained settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 years and above presenting with symptoms as indicated in national COVID-19 standard cases definitions or
- •Presence of one or more respiratory symptoms (fever (defined as >37.5°C), Persistent coughs, headache, myalgia, sore throat ) or One risk factor for COVID-19, including known contact with a patient with COVID-19, underlying comorbidities, smoking.
- •Provision of an informed consent/assent (for minors aged 11-17 years) by themselves or parents/guardians to participate
排除标准
- •Inability or unwillingness to give written informed consent/assent.
结局指标
主要结局
Proportion of patients with SARS-CoV-2 infection
时间窗: 24 months
The study will screen patients with respiratory tract infections suggestive of SARS-CoV-2 infection
次要结局
未报告次要终点
研究者
Daniel T Minja, PhD
Principal Investigator
National Institute for Medical Research, Tanzania
