Researchers from Osaka Metropolitan University (OMU), K.K. DNAFORM, and the National Institute for Biomedical Research (INRB) in the Democratic Republic of the Congo are developing a portable rapid diagnostic system for Ebola virus disease caused by Bundibugyo virus (BDBV). The project has received support from the Global Health Innovative Technology Fund (GHIT Fund).
The development effort follows the World Health Organization’s declaration of a Public Health Emergency of International Concern (PHEIC) related to a BDBV outbreak in the Democratic Republic of the Congo and Uganda. In outbreak settings, rapid testing is essential for identifying cases, supporting patient isolation, guiding contact tracing, and informing treatment decisions.
Portable testing for outbreak response
BDBV is a member of the Ebolavirus genus but is distinct from Ebola virus (EBOV, formerly Zaire ebolavirus). Because existing vaccines and diagnostic systems developed for EBOV may not directly apply to BDBV, reliable tests capable of detecting and differentiating BDBV are needed.
The research team is developing the GenPad Smart BDBV Portable Rapid Diagnostic System using K.K. DNAFORM’s GenPad platform, which is based on SmartAmp isothermal PCR technology with Eprobe detection. The system is designed for use near the site of patient care, including locations with limited laboratory infrastructure and power availability.
Initial laboratory evaluations found that the prototype met its target limit of detection of ≤200 copies per cartridge and showed no cross-reactivity against a panel of 86 microbial species. The device is designed to be portable, weighing 460 grams, and can operate on battery power for up to eight tests per charge. Results are intended to be available in approximately 30 minutes from blood collection.
The system uses sealed cartridges designed to simplify sample handling and reduce exposure risks after appropriate training. Multiple devices can also be combined to support simultaneous testing of multiple samples.
Building a rapid diagnostic development framework
The project is aligned with the international “100-Day Mission,” which aims to develop and deploy diagnostics, therapeutics, and vaccines within 100 days of identifying an emerging infectious disease threat.
The team’s development framework combines OMU’s infectious disease research network, K.K. DNAFORM’s portable nucleic acid testing technology, and INRB’s outbreak investigation expertise. Future work will include performance validation using non-infectious mock samples, clinical performance validation using samples from the Democratic Republic of the Congo, and preparation of data for potential WHO Emergency Use Listing and other emergency regulatory pathways.
The researchers are also developing a multiplex version capable of differentiating BDBV, EBOV, and Sudan virus (SUDV) within a single cartridge, while prioritizing completion of the BDBV-specific test to address current outbreak needs.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
