Rapid diagnostic tests

Topic description

Scope:

Specific challenge

Rapid detection of Ebola infections in the field or at decentralised healthcare centers is an urgent need in the current crisis of the outbreak of EVD and will remain important even after the current crisis may have subsided. Additional technologies addressing various healthcare facilities settings will also be important to maintain surveillance in the long term. Current PCR-based tests have a number of limitations related to time and procedures requiring infrastructures and specific training. Tools and technologies are needed to provide quality diagnostics at low cost. Several such tests are already under development but their performance and practicability are unknown.

Scope

The project(s) will work on developing rapid diagnostics to detect EVD at acceptable costs and with very high sensitivity and specificity. At a minimum a rapid diagnostic test should be able to be deployed at decentralised health care facilities under conditions with minimum laboratory infrastructures available. Projects can work on validating existing tests or on expanding the use of tools currently being developed, through clinical validation to registration and launch. Projects must in any case include a phase of clinical validation in the field under real-world conditions, address manufacturing and access path to ensure sustainable distribution including taking into account ethical considerations and the health systems context. Any suitable technology can be used but the focus should be on practical solutions that meet the following criteria:

-       Very high sensitivity and specificity

-       Ability to be deployed in resource-limited settings

-       Minimal training required to operate

-       Capability of multiplexing in order to include different ebola strains

-       Time to result 15-30 minutes (desirable) – 3 hours (acceptable)

-       Sample type for intake: blood (capillary fingerstick desirable), other less invasive sample types (urine, etc.)

Additional capabilities to provide epidemiological monitoring (eg. Internet connectivity) would be valuable.

It is considered that an IMI2 JU financial contribution of approximately 7.5 million and an EFPIA in-kind contribution of approximately EUR 7.5 million would allow this specific challenge to be addressed appropriately. Nevertheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact

Increased availability of rapid diagnostic tests for EVD, providing in a first step immediate impact on public health in regions where the disease is endemic.

Possible impact on business opportunities for European SMEs active in this area.

International cooperation