Development and evaluation of a novel RT-qPCR assay for detection of Crimean Congo haemorrhagic fever virus using the Genedrive® point-of-care platform

Introduction: Crimean-Congo haemorrhagic fever (CCHF) is a viral haemorrhagic fever classed by the World Health Organization as a priority disease due to the lack of countermeasures. A point-of-care (POC) diagnostic test for rapid detection of positive cases to expedite patient management is not currently available but urgently needed. Methods: We have developed an RT-qPCR assay to be used with the commercially available POC Genedrive® PCR platform enabling viral detection in serum with minimal sample preparation. The sensitivity and specificity of the novel assay in the Genedrive® was evaluated against the RealStar® CCHFV RT-qPCR Kit (Altona Diagnostics, Germany). Results: The sensitivity and specificity in assay V1 (sample n = 150) were 94.4 % (95 % CI, 88.2–97.9) and 97.6 % (95 % CI, 87.1–99.9). For assay (n = 55) V2 sensitivity was 92.3 % (95 % CI, 74.9–99.5) and specificity was 100 % (95 % CI, 87.7–100). Conclusions: This study supports the feasibility of diagnosing CCHF using POC RT-qPCR platforms, having the potential to reduce turnaround times, leading to improved clinical management.