Portable rapid diagnostic system for Ebola disease

1. Introduction Ebola virus disease (EVD) caused by Bundibugyo virus (BDBV), for which WHO declared a Public Health Emergency of International Concern (PHEIC) on 17 May 2026, has highlighted the urgent need to develop rapid diagnostics, as existing EVD tests may not detect BDBV. Laboratory-based diagnosis remains essential for confirming EVD; however, in outbreak settings with limited healthcare resources, it is often difficult to obtain rapid results close to patients. In this project, we will develop and evaluate a point-of-care (POC) testing system for EVD using GenPad, a portable isothermal nucleic acid amplification platform developed by K.K. DNAFORM. By combining Osaka Metropolitan University's global research network, DNAFORM's GenPad technology, and Institut National de Recherche Biomédicale (INRB)s infrastructure for responding to emerging infectious diseases, the project aims to contribute to both the current BDBV outbreak response and future preparedness for Ebola virus disease. 2. Project Objective This project aims to develop two EVD diagnostic cartridges based on the GenPad platform and to evaluate their clinical performance. In response to the current PHEIC, development will first prioritize a BDBV-specific cartridge. The project will subsequently develop a multiplex cartridge capable of detecting and differentiating BDBV, Ebola virus (EBOV), and Sudan virus (SUDV) in a single test. Both tracks share the same GenPad platform and primer/probe design framework. At the laboratory level, the system has met the WHO Emergency Use Listing (EUL) performance target for limit of detection of 200 copies per test or lower. Based on the data generated, the project will prepare technical documentation for WHO EUL and support future field deployment after completion of the necessary regulatory and public health procedures. 3. Project Design This project will develop two test kits in parallel. While priority will be given to the BDBV single-target test kit, a multiplex version capable of differentiating BDBV, EBOV, and SUDV in a single cartridge will also be developed in parallel. The development process includes: (1) reagent design, prototype manufacturing, and laboratory evaluation using the genome sequence of the BDBV outbreak strain; and (2) performance verification using contrived specimens and clinical specimens. Through this two-track parallel development strategy, the project aims to respond to the immediate need for BDBV-specific testing while also building a versatile testing platform that may be applicable to future Ebola virus disease outbreaks. The consortium will also work in close coordination with WHO and other international organizations.