Introduction and Background of the Project

Introduction
Ebola virus disease is a highly fatal infectious disease that can spread rapidly during outbreaks. However, the most sensitive diagnostic method currently available, PCR, requires specialized laboratories, equipment, and trained personnel, making it difficult to access in many outbreak regions. On the other hand, existing rapid tests are easy to use but often lack sufficient sensitivity, particularly during the early stages of infection. This project aims to develop a novel rapid diagnostic test for Ebola using Saitama University’s ultra-sensitive detection technology, enabling accurate diagnosis directly at the point of care.

Project Objective
The objective of this project is to develop a portable diagnostic kit capable of detecting Ebola virus infection with high sensitivity in less than 15 minutes. The test will be designed for use by frontline healthcare workers without requiring laboratory infrastructure, enabling earlier detection, patient isolation, and treatment. Ultimately, the project aims to support global Ebola control efforts and contribute to improved public health outcomes through faster and more accessible diagnosis.

Project Design
The project will first identify Ebola-specific target antigens and high-performance antibody pairs. These components will then be integrated into a highly sensitive diagnostic platform based on proprietary Aggregation-Induced Emission (AIE) fluorescent nanoparticle technology. The prototype will be optimized for analytical performance and evaluated for stability under harsh environmental conditions, such as high temperature and humidity. Usability testing will also be conducted to ensure effective operation in resource-limited settings. In parallel, preparations will be made for future clinical validation and regulatory approval.

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

A major challenge in Ebola outbreak regions is the difficulty of identifying infected individuals early enough to prevent further transmission. This technology will enable highly accurate testing even in areas with limited medical infrastructure. Early detection will support rapid isolation and treatment of infected individuals, helping to reduce transmission and mortality. Furthermore, because the platform can be adapted to detect other infectious diseases, it has the potential to strengthen global preparedness for future epidemics and pandemics.

What sort of innovation are you bringing in your project?

The key innovation of this project is its ability to combine PCR-like sensitivity with the simplicity and convenience of a rapid diagnostic test. By using AIE fluorescent nanoparticle technology, which provides 100 to 1,000 times greater sensitivity than conventional rapid tests, the system can detect extremely low levels of viral antigens during the early stages of infection. The test is also portable, easy to use, and does not require sophisticated equipment or specialized expertise. In addition, the platform can be rapidly adapted for a wide range of emerging infectious diseases, making it a transformative next-generation diagnostic technology.

Role and Responsibility of Each Partner

Saitama University (Lead Organization)
·     Overall project leadership and management. 
·     Development of AIE fluorescent nanoparticles and diagnostic technology. 
·     Antibody selection, assay design, and optimization. 
·     Performance evaluation, data analysis, and regulatory preparation. 
·     Coordination of future clinical validation and WHO-related activities. 

Future Industrial Partners
·     Development of scalable manufacturing processes.
·     Establishment of quality control systems.
·     Large-scale production and product distribution.

Clinical and Field Partners
·     Clinical performance assessment.
·     Identification of local healthcare needs.
·     Support for field implementation and adoption.

At the current stage, Saitama University will conduct the core research and development activities and serve as the primary project coordinator.