Emperador Devy M, Mazzola Laura T, Wonderly Trainor Betsy, Chua Arlene, Kelly-Cirino Cassandra
FIND, Emerging Threats Programme, Geneva, Switzerland.
FIND, Geneva, Switzerland.
BMJ Glob Health. 2019 Feb 7;4(Suppl 2):e001112. doi: 10.1136/bmjgh-2018-001112. eCollection 2019.
Ebolaviruses and Marburg virus (MARV) both belong to the family and cause severe haemorrhagic fever in humans. Due to high mortality rates and potential for spread from rural to urban regions, they are listed on the WHO R&D blueprint of high-priority pathogens. Recent ebolavirus outbreaks in Western and Central Africa have highlighted the importance of diagnostic testing in epidemic preparedness for these pathogens and led to the rapid development of a number of commercially available benchtop and point-of-care nucleic acid amplification tests as well as serological assays and rapid diagnostic tests. Despite these advancements, challenges still remain. While products approved under emergency use licenses during outbreak periods may continue to be used post-outbreak, a lack of clarity and incentive surrounding the regulatory approval pathway during non-outbreak periods has deterred many manufacturers from seeking full approvals. Waning of funding and poor access to samples after the 2014-2016 outbreak also contributed to cessation of development once the outbreak was declared over. There is a need for tests with improved sensitivity and specificity, and assays that can use alternative sample types could reduce the need for invasive procedures and expensive equipment, making testing in field conditions more feasible. For MARV, availability of diagnostic tests is still limited, restricted to a single ELISA test and assay panels designed to differentiate between multiple pathogens. It may be helpful to extend the target product profile for ebolavirus diagnostics to include MARV, as the viruses have many overlapping characteristics.
埃博拉病毒和马尔堡病毒(MARV)都属于[此处原文缺失病毒所属的科名]科,可引起人类严重出血热。由于高死亡率以及从农村地区传播至城市地区的可能性,它们被列入世界卫生组织高优先级病原体研发蓝图。近期在西非和中非爆发的埃博拉病毒疫情凸显了针对这些病原体进行疫情防范时诊断检测的重要性,并促使快速开发出了许多商用台式和即时检测核酸扩增检测以及血清学检测和快速诊断检测。尽管取得了这些进展,但挑战依然存在。虽然在疫情期间根据紧急使用许可批准的产品在疫情结束后可能会继续使用,但在非疫情期间,监管审批途径缺乏明确性和激励措施,这阻碍了许多制造商寻求全面批准。2014 - 2016年疫情爆发后资金减少以及获取样本困难,也导致疫情宣布结束后研发工作停止。需要提高检测的灵敏度和特异性,能够使用替代样本类型的检测方法可以减少侵入性操作和昂贵设备的需求,使现场检测更加可行。对于马尔堡病毒,诊断检测的可用性仍然有限,仅限于单一的酶联免疫吸附测定(ELISA)检测和旨在区分多种病原体的检测组合。将埃博拉病毒诊断的目标产品简介扩展至包括马尔堡病毒可能会有所帮助,因为这两种病毒有许多重叠特征。