Introduction and Background of the Project

Introduction
Ebola virus disease (EVD) is a severe infectious disease associated with a high case-fatality rate and a significant risk of transmission. Following the 2026 outbreak caused by Bundibugyo ebolavirus, the World Health Organization (WHO) has strengthened its response under the International Health Regulations framework [1]. To prevent further spread of the disease, early identification of infected individuals and the prompt implementation of isolation and infection control measures are essential. Therefore, the establishment of a rapid diagnostic system has become an urgent priority.
Currently, reverse transcription polymerase chain reaction (RT-PCR), the most widely used molecular diagnostic method, provides highly accurate detection of infection; however, it requires specialized laboratory infrastructure and well-trained personnel [2]. In contrast, antigen-based rapid diagnostic tests can provide results within a short period of time, but may fail to detect infection when viral loads are low, particularly during the early stages of infection [3–4]. Furthermore, there are currently limited diagnostic tools capable of rapidly and accurately detecting the Bundibugyo ebolavirus responsible for the ongoing outbreak [5].

This project aims to develop a novel diagnostic method for the simple and rapid detection of Bundibugyo ebolavirus, thereby supporting early case identification and timely isolation decisions in outbreak settings.

Project Objective
The objective of this project is to develop a novel diagnostic device for the rapid and, user-friendly detection of Bundibugyo ebolavirus. Given the limited availability of laboratory infrastructure and trained healthcare personnel in outbreak-affected regions, the project aims to establish a diagnostic system that can be used in field settings, including healthcare facilities and community clinics, without requiring sophisticated laboratory equipment. By enabling early identification of infected individuals and timely implementation of infection control measures, the proposed system is expected to contribute to reducing disease transmission and supporting outbreak containment.

Project Design
This project aims to develop a novel diagnostic method that combines RT-LAMP with nucleic acid chromatography to enable rapid and accessible visual detection of Bundibugyo ebolavirus. Unlike conventional PCR-based methods, MEBLINE BDBV does not require the sophisticated laboratory equipment used for PCR testing, making it suitable for use in healthcare facilities and community clinics. By combining the accuracy of molecular diagnostic tests with the rapid and practical features of antigen tests, this technology can support the rapid detection of infected individuals in outbreak settings.
Furthermore, the platform may be adaptable to the detection of other Ebola virus species, providing a valuable tool for preparedness against future outbreaks.

How can your partnership (project) address global health challenges?

In regions affected by infectious disease outbreaks, limited diagnostic capacity is a major factor contributing to the spread of infection. When infected individuals cannot be identified at an early stage, the risk of disease transmission within communities and among healthcare workers increases.

By developing a rapid and easy-to-use diagnostic system for use in outbreak settings, this project aims to enable the early detection of infected individuals and the timely implementation of isolation measures. This will help reduce disease transmission and support rapid public health responses.

Furthermore, the diagnostic platform developed through this project, which combines RT-LAMP with nucleic acid chromatography, can be adapted for the detection of other Ebola virus species and emerging infectious diseases. This adaptability may help strengthen preparedness for future outbreaks and improve access to diagnostic testing.

What sort of innovation are you bringing in your project?

The innovation of this project lies in the development of a diagnostic system that combines RT-LAMP, a highly sensitive nucleic acid amplification technology, with nucleic acid chromatography, which enables the simple visual interpretation of test results. By integrating high detection performance with ease of use in field settings, the proposed system aims to support the rapid identification of infected individuals and timely public health interventions without requiring large-scale laboratory equipment or specialized facilities. In addition, the platform has the potential to be adapted for the detection of other Ebola virus species in the future.

Role and Responsibility of Each Partner

Medical & Biological Laboratories Co., Ltd. (MBL) will lead the overall management of the project and be responsible for the design, development, performance evaluation, and preparation for practical implementation of the diagnostic system. Nagasaki University will contribute its expertise in Ebola virus research and RT-LAMP technology to support the design and evaluation of the detection method. By leveraging their respective strengths and working collaboratively, the two organizations aim to develop a simple, rapid, and highly accurate diagnostic system suitable for use in outbreak settings.

Others (including references if necessary)

[1] Consult: https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern

[2] Nouvellet, Pierre, et al. "The role of rapid diagnostics in managing Ebola epidemics." Nature 528.7580 (2015): S109-S116. 

[3] Muzembo, Basilua Andre, et al. "Rapid diagnostic tests versus RT–PCR for Ebola virus infections: a systematic review and meta-analysis." Bulletin of the World Health Organization 100.7 (2022): 447.

[4] Mukadi-Bamuleka, Daniel, et al. "Field performance of three Ebola rapid diagnostic tests used during the 2018–20 outbreak in the eastern Democratic Republic of the Congo: a retrospective, multicentre observational study." The Lancet Infectious Diseases 22.6 (2022): 891-900.

[5] Consult: https://africacdc.org/download/molecular-diagnostic-tests-rt-pcr-for-ebola-virus-bundibugyo-strain/