Development and evaluation of a novel RT-qPCR assay for detection of Crimean Congo haemorrhagic fever virus using the Genedrive(R) 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(R) PCR platform enabling viral detection in serum with minimal sample preparation. The sensitivity and specificity of the novel assay in the Genedrive(R) was evaluated against the RealStar(R) 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.