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临床试验/NCT04235361
NCT04235361Unknown不适用

Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC

University of Stirling4 个研究点 分布在 4 个国家目标入组 500 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
4
主要终点
Recombinase polymerase amplifictaion test result

研究概览

简要总结

A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015.

It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method.

In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method.

Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.

详细描述

In the Ebola outbreak in Guinea up to 90% of patients tested negative but were rarely diagnosed for differentials and Malaria and other diseases went under-diagnosed, which most likely lead to more deaths from these infectious agents. Another important aspect is that, the fear of the patients of having Ebola, while they are suffering from other disease must be overcome by providing the correct diagnosis of the type of the pathogen timely. [Dunbar NK et al.].

The RPA assay is six times faster than conventional real-time PCR while yielding the same analytical sensitivity and specificity. In addition, the RPA format (equipment size, cold-chain independent reagents) makes rapid on-site testing feasible and affordable. We developed a mobile laboratory, which consists of a hard plastic glovebox a Diagnostics-in-a-Suitcase (DiaS), and a solar panel and power pack set. The disassembled glovebox is kept in a metal box (80 × 60 × 41 cm) with other necessary materials (disinfectant solution, extraction kits, filter tips, racks, vortex, heat block, autoclavable plastic bags and personal protective equipment (PPE). The total weight is 28 kg for the box and 16 kg for the DiaS. Sample inactivation and RNA extraction using the SE kit so far were done in the glovebox. This allowed handling of hazard group 4 samples. The RT-RPA assay was performed in the DiaS containing the ESEQuant TS2 device with integrated touchscreen to operate the device and display the results without the need of a laptop, which is not easy to disinfect (Figure 1).The mobile lab was successfully deployed in Conakry when an increasing number of cases, due mainly to non-reporting, reticence, and infection transmission chains during burials developed towards the end of 2014. To provide quick results for the safe and dignified burial (SDB) programme two mobile laboratories were set up in the Matoto Gbessia Port II district. Altogether 928 post-mortem swab samples were tested. Overall, 120 samples (12.9%) scored positive. Positive results were obtained within 30-40 min and reported directly to the SDB teams [Faye O et al.].

APPROACH

Objective:

To assess the performances and operational characteristics of the differential RPA we will use i) a panel of well characterized EBOV sera from samples collected in Guinea and DRC ii) sera from EVD suspect cases, and iii) sera from routine diagnostics at IPD and NIBR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Recombinase polymerase amplifictaion test result

时间窗: The test result will be provided on the same day as the sample is received. The test procedure takes up to 3hours

The test results will be provided in Time of Threshold (TT) values

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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