A prototype rapid test for Crimean-Congo haemorrhagic fever (CCHF) now needs to be refined, manufactured at scale, and trialled in 492 patients in Turkey. CCHF kills a high proportion of those infected, and the only antiviral that may help must be given early. But current lab tests take two to five days to return results—too slow to guide treatment. The World Health Organization has made a rapid diagnostic test a priority. This project aims to deliver one. The test, developed at the Liverpool School of Tropical Medicine with Global Access Diagnostics, already meets WHO targets for sensitivity and specificity. The team will now optimise it in an ISO-accredited facility, lock the design, and evaluate it against all CCHF viral lineages. Clinical trials in hyperendemic regions of Turkey will generate data for UKCA regulatory approval. A market scoping exercise will identify customers and pathways to bring the test into use. If successful, the test could cut diagnosis from days to minutes at the point of care, allowing early antiviral treatment and improving patient survival. It would also give clinicians in outbreak settings a practical tool to identify cases quickly, supporting infection control and reducing onward transmission.
View original technical description
Crimean-Congo haemorrhagic fever (CCHF) is a World Health Organisation (WHO)-listed priority disease due to its high mortality and lack of vaccines and effective treatment and diagnostics. Patients with CCHF have a high mortality and there is only one antiviral used that may only be effective if given early in disease. However, the current turnaround of test results for CCHF diagnosis is slow with a 2-5-day delay causing reduced treatment efficacy and poor patient recovery. The development of rapid diagnostic tests (RDTs) for rapid diagnosis of CCHF has been identified as a priority by the WHO. This proposal seeks to address this need and the Liverpool School of Tropical Medicine (LSTM) in collaboration with Global Access Diagnostics (GADx) have achieved the development of the first RDT prototype to diagnose CCHF with a sensitivity and specificity that fulfils the recommendations from WHO for RDTs. LSTM in collaboration with GADx will optimise the RDT to refine sensitivity and specificity within an ISO-accredited environment. GADx will perform up-scale of manufacturing techniques including bulk conjugations and use quality control systems within their Quality Management System to ensure that the RDT preserves its original performance between batches and when manufactured at commercial volumes. We will do a market scoping exercise to identify the customers and pull through mechanisms to market for this important RDT. We will design-lock the product with all the kit components for evaluation. Firstly, we will perform analytical evaluations across all CCHF viral lineages with UK Health Security Agency (UKHSA) and following this we will evaluate the RDT in banked samples at the Ministry of Health (MoH) in Turkey and the Centers for Disease Control and Prevention (CDC) in Iraq. Also, in collaboration with the MoH, LSTM will set up clinical trials for diagnostic evaluation of the RDT among 492 patients attending secondary health clinics in CCHF hyperendemic regions in Turkey. Data from these trials will be used for preparation of regulatory submission under UKCA marking.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know