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临床试验/NCT05514886
NCT05514886Unknown不适用

Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings

National Institute for Medical Research, Tanzania1 个研究点 分布在 1 个国家目标入组 3,600 人开始时间: 2022年9月1日最近更新:
适应症

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

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

发起方
National Institute for Medical Research, Tanzania
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Daniel T Minja, PhD

Principal Investigator

National Institute for Medical Research, Tanzania

研究点 (1)

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