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The GeneDrive Crimean Congo Haemorrhagic Fever assay; from prototype to design freeze
Investigator(s): Dr Thomas Edwards
Amount Awarded: 83,268

Crimean Congo Haemorrhagic Fever (CCHF) is a viral infection, transmitted by the bites of infected ticks. It is endemic in several African and Asian countries, and particularly prevalent in Turkey. Symptoms of CCHF can include fever, headache, muscle aches, haemorrhages, and shock, and typically last up to two weeks. Between 5 and 40% of cases die depending on the setting.

The diagnosis of CCHF relies on identification of viral RNA by RT-qPCR, which can only be carried out in well-equipped laboratories, often far removed from hospitals and clinics where patients present. Delays in diagnosis can lead to inadequate safety precautions being taken by healthcare and laboratory staff, and obstructs the development of tailored patient management.

We have developed a point of care molecular test on the GeneDrive platform, and have evaluated the test at PHE Porton Down on archived samples, where it achieved an accuracy of 95.3% against a best-in-class commercial laboratory assay, exceeding the recommendations of the World Health Organization in their CCHF R&D roadmap.

We will now further develop this prototype assay into a final test ready for CE marking. This will include the design of an internal control, the optimisation and production of lyophilised assay cartridges, and modification of the sample preparation from a two-step to a one-step process. These steps are likely to improve test sensitivity and speed, and are required in order to have a commercially viable test. The final test will be prospectively evaluated in Turkey at the national reference laboratory in Ankara.