Introduction and Background of the Project

Introduction
The project aims to address the question of whether a rapid antigen test (RAT) for NiV and HeV can serve as a dependable, field-deployable diagnostic tool that supports early outbreak detection and containment in low resource settings (LRS). Both pathogens share ecological and virological characteristics and are of considerable public health significance, having been classified as high-priority global pathogens under WHO’s R&D Blueprint due to their capacity to cause severe outbreaks.1 Both pathogens have the same shared bat reservoirs and NiV has repeatedly emerged in South and Southeast Asia, while HeV circulates in Eastern Australia. Of great concern with respect to this risk is that there is the lack of countermeasures to both viruses; no approved vaccines or therapeutics are available for NiV or HeV.1–4 The mortality rates for NiV outbreaks can exceed 70%, largely due to delayed diagnosis and lack of treatment options.5

Project Objective
Our goal is to deliver an affordable, robust, easy-to-use, and highly accurate RAT that detects and discriminates between NiV and HeV infections. This tool will enable early outbreak detection in rural and LRSs, reducing transmission and saving lives. 

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

The SHIELD project targets a major unmet need in global health with the current absence of RATs for NiV and HeV—zoonotic pathogens with high case-fatality rates and recognized by WHO as priority pathogens with the potential to cause a “Disease X” pandemic. Both viruses are carried by Pteropus fruit bats, whose geographic range spans from West Africa to Japan, placing billions of people at risk, particularly in rural and underserved regions where surveillance systems are weak and where humans, livestock (swine and other animals for NiV, horses for HeV), and fruit bats coexist.
Currently, no commercial rapid tests exist for NiV or HeV, leaving outbreak detection dependent on centralized laboratory testing via culture and molecular methods, which are slow, costly, and inaccessible in austere environments. Delays in diagnosis increase transmission risk and mortality, especially in settings where early isolation and contact tracing are critical for containment. The lack of point-of-care tools also hampers One Health surveillance, limiting the ability to monitor spillover events in animals and humans.

What sort of innovation are you bringing in your project?

The project is a partnership with iBody for antibody development and mining using Ecobody, their proprietary methodology for recombinant antibody generation. PATH will augment iBody’s work by antibody screening, prototype RAT design, and analytical benchmarking of the RAT. Together, the partnership will deliver a de-risked prototype ready for scale-up with global access to the core reagents.

Role and Responsibility of Each Partner

PATH is responsible for overall implementation of this project. Specifically, PATH will lead on the prototype immunoassay and RAT development as well as the commercialization plan for the RAT.  
iBody will be responsible for host immunization and antibody screening and generation. 

Others (including references if necessary)

1. WHO R&D Blueprint: Priority Diagnostics for Nipah. (2019).

2. Gazal, S. et al. Nipah and Hendra Viruses: Deadly Zoonotic Paramyxoviruses with the Potential to Cause the Next Pandemic. Pathogens 11, 1419 (2022).

3. Eaton, B. T., Broder, C. C., Middleton, D. & Wang, L.-F. Hendra and Nipah viruses: different and dangerous. Nat. Rev. Microbiol. 4, 23–35 (2006).

4. Halpin, K. & Rota, P. A Review of Hendra Virus and Nipah Virus Infections in Man and Other Animals. Zoonoses - Infect. Affect. Hum. Anim. 997–1012 (2014) doi:10.1007/978-94-017-9457-2_40.

5. Arunkumar, G. et al. Outbreak Investigation of Nipah Virus Disease in Kerala, India, 2018. J. Infect. Dis. 219, 1867–1878 (2019).