If you are an IVD manufacturer looking to expand into infectious disease diagnostics for resource-limited settings — this project developed and validated a multiplex lateral flow assay integrated with RPA molecular detection that identifies multiple hemorrhagic fever viruses in a single test. The 3-LFD strip has been optimized into a U-star cassette format ready for manufacturing scale-up, validated with real patient materials across a 17-partner consortium spanning 9 countries.
Portable Rapid Test Kits for Detecting Deadly Hemorrhagic Fevers at the Bedside
Imagine trying to figure out if someone has Ebola — but you're in a remote clinic with no lab equipment, and every hour counts. This project built something like a pregnancy test for deadly viral fevers: a small strip you can run at a patient's bedside that tells you within minutes whether they're infected. Even better, one test can check for multiple viruses at once, so doctors don't have to guess which disease they're dealing with. The team validated these rapid tests with real patient samples and packaged them into ready-to-use cassettes for field deployment.
What needed solving
Diagnosing viral hemorrhagic fevers like Ebola currently requires sophisticated laboratory equipment that is rarely available in the remote African clinics where outbreaks actually happen. This delay in diagnosis costs lives and allows outbreaks to spread unchecked. Healthcare providers and outbreak response teams need a fast, portable, affordable test that works at the bedside — not in a distant reference lab.
What was built
The project built multiplex rapid diagnostic tools combining molecular detection (RPA) with lateral flow assays, validated with real patient materials. Concrete outputs include: an integrated 3-lateral-flow-device RPA strip optimized into a U-star cassette for point-of-care use, monoclonal antibodies for antigen detection assays, and quality-controlled lyophilized reagents for field deployment.
Who needs this
Who can put this to work
If you are an outbreak response organization that needs to diagnose hemorrhagic fevers quickly in field conditions — this project built point-of-care diagnostic tools specifically designed for primary care settings and field laboratories. The lateral flow assays were manufactured and evaluated for use outside conventional labs, with capacity building programs already established in West Africa through twinning partnerships.
If you are a biotech supplier looking for validated reagent platforms for infectious disease detection — this project produced monoclonal antibodies used in both ELISA and lateral flow antigen detection assays, plus quality-controlled lyophilized reagents for point-of-care use. These reagents were developed across 5 industry partners and validated through preclinical and field testing, representing a ready-to-license reagent pipeline.
Quick answers
What would it cost to license or acquire this diagnostic technology?
The project does not publish specific licensing fees or unit costs. With 5 industry partners and 3 SMEs already in the consortium, commercial terms would need to be negotiated with the coordinator (Folkhälsomyndigheten, Sweden) or the relevant IP-holding partners. SciTransfer can facilitate introductions to the right contact.
Can these rapid tests be manufactured at industrial scale?
The lateral flow assays were explicitly manufactured for evaluation in primary care settings and field laboratories, and the 3-LFD strip was optimized into a U-star cassette format — a standard commercial diagnostic housing. This suggests the technology is designed for scalable production, though full commercial manufacturing volumes would require partnership with an established IVD manufacturer.
Who owns the intellectual property and how is it licensed?
IP ownership typically sits with the consortium partners who developed each component. The monoclonal antibodies, the RPA assay design, and the lateral flow strips may each have separate IP holders among the 17 partners. Based on available project data, exploitation of results was a stated objective, suggesting licensing pathways exist.
Has this been tested in real-world conditions?
Yes. The integrated 3-LFD RPA was validated with actual patient materials, and the lateral flow assays were manufactured specifically for evaluation in primary care settings and field laboratories. The project also included a twinning capacity-building program in West Africa, indicating field deployment infrastructure.
What diseases does this test cover?
The project targeted Filoviruses (including Ebola) and other viral hemorrhagic fever diseases. The multiplex format means a single test can screen for multiple pathogens simultaneously, which is critical during outbreaks when the causative virus is initially unknown.
How long did development and validation take?
The project ran from January 2019 to December 2023, a 5-year development cycle. This included molecular and serological method development, preclinical validation, and field validation — a complete development pipeline from lab to bedside testing.
Is there regulatory approval?
Based on available project data, the tests were validated preclinically and under field conditions but there is no mention of CE marking or WHO prequalification. Regulatory submissions would likely be the next step for any commercial partner looking to bring these diagnostics to market.
Who built it
This is a strong, well-balanced consortium of 17 partners from 9 countries including Senegal — critical for African field validation. The mix is nearly equal between industry (5), universities (5), and research organizations (5), with 3 SMEs bringing agility to commercialization. At 29% industry participation, the project had meaningful commercial input throughout development. The coordinator is Sweden's Public Health Agency (Folkhälsomyndigheten), lending regulatory credibility. The inclusion of partners from both European developer nations (DE, FR, UK, DK, IT, BE, SE) and an African deployment country (SN — Senegal) shows the technology was built where it needs to work, not just where the labs are.
- FOLKHALSOMYNDIGHETENCoordinator · SE
- INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALEparticipant · FR
- MEDIZINISCHE HOCHSCHULE BRANDENBURG CAMPUS GMBHparticipant · DE
- CORIS BIOCONCEPT SPRLparticipant · BE
- KOBENHAVNS UNIVERSITETparticipant · DK
- INSTITUT PASTEUR DE DAKARparticipant · SN
- Department of Healthparticipant · UK
- INSERM TRANSFERT SAparticipant · FR
- THE UNIVERSITY OF STIRLINGparticipant · UK
- ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI-ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICOparticipant · IT
- UNIVERSITE D'AIX MARSEILLEparticipant · FR
- INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENTthirdparty · FR
- EMERGENCY LIFE SUPPORT FOR CIVILIAN WAR VICTIMS ONG ONLUSparticipant · IT
Folkhälsomyndigheten (Public Health Agency of Sweden) — contact through SciTransfer for warm introduction to project coordinator
Talk to the team behind this work.
Want to license this multiplex rapid diagnostic technology or explore manufacturing partnerships? SciTransfer can connect you directly with the right consortium partner. Contact us for a tailored briefing.