Introduction and Background of the Project

Introduction
Ebola disease remains a serious public health threat, particularly in African countries where outbreaks can spread rapidly and place major pressure on health systems. Bundibugyo virus (BDBV), one of the viruses that causes Ebola disease, has fewer dedicated diagnostic options than the better-known Zaire ebolavirus. Outbreaks of BDBV in the Democratic Republic of the Congo and Uganda have been declared public health emergencies by the World Health Organization (WHO). Rapid identification of infected people is essential for timely isolation, clinical management, and outbreak control. Eiken Chemical Co., Ltd. will apply its long-standing expertise in loop-mediated isothermal amplification (LAMP) to develop a rapid nucleic acid test designed specifically for BDBV. To lower the barrier to adopting the testing system, the assay will be designed for use with existing PCR instruments. This will help laboratories respond more quickly during outbreaks. The project is expected to help contain the current spread of infection while strengthening preparedness for future outbreaks.

Project Objective
The project aims to develop a prototype reverse-transcription LAMP reagent that can detect BDBV rapidly and specifically. The target is to achieve a 15-minute result while maintaining sensitivity comparable to existing real-time PCR assays. The project will also evaluate whether the assay can be used with multiple real-time PCR instruments. Ultimately, the prototype developed through this project is intended to undergo external pre-evaluation by WHO or other public health organizations to demonstrate its potential utility for future clinical applications.

Project Design
The six-month project consists of three sequential stages. First, Eiken will compare publicly available BDBV genome sequences, select conserved target regions, and design LAMP primers and fluorescence probes. Candidate assays will be screened using non-infectious synthetic RNA or equivalent reference materials, and reaction conditions will be optimized for rapid and specific detection. Second, the selected assay will undergo preliminary analytical evaluation, including sensitivity, interference, and instrument-compatibility studies using contrived whole-blood or plasma samples. Third, the optimized formulation will be transferred to a freeze-dried prototype format. Eiken will manufacture 10,000 prototype tests using existing facilities and conduct performance evaluation.

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

Many Ebola diagnostic tests have been developed mainly for Zaire ebolavirus, while dedicated options for BDBV remain limited. This gap can delay case confirmation and public health action during BDBV outbreaks. A rapid, accessible nucleic acid test could support earlier identification of infected people, faster isolation, and more timely outbreak-control measures. The proposed assay is designed to work with real-time fluorescence instruments that may already be available in central laboratories, reducing the need for major new equipment investment. In the longer term, the underlying approach may be expanded to detect and distinguish multiple ebolaviruses and adapted for settings with more limited laboratory infrastructure, thereby strengthening preparedness for future outbreaks.

What sort of innovation are you bringing in your project?

LAMP, a technology originally developed by Eiken, is a nucleic acid amplification method that proceeds at a constant temperature and can therefore be performed using relatively simple equipment. Because it does not require the repeated temperature cycling used in PCR, it may provide results more rapidly. This project is innovative because it will develop a BDBV testing system based on LAMP that can also be read on commonly available real-time PCR instruments, thereby shortening the time required for conventional testing and enabling faster isolation and clinical management.

Role and Responsibility of Each Partner

Eiken Chemical Co., Ltd. is the Designated Development Partner and will implement the entire project independently. No other collaboration partner is currently included in the project.