Kelly-Cirino Cassandra, Mazzola Laura T, Chua Arlene, Oxenford Christopher J, Van Kerkhove Maria D
Emerging Threats Programme, FIND, Geneva, Switzerland.
Department of Information, Evidence and Research, WHO, Geneva, Switzerland.
BMJ Glob Health. 2019 Feb 1;4(Suppl 2):e001105. doi: 10.1136/bmjgh-2018-001105. eCollection 2019.
Diagnostics play a central role in the early detection and control of outbreaks and can enable a more nuanced understanding of the disease kinetics and risk factors for the Middle East respiratory syndrome-coronavirus (MERS-CoV), one of the high-priority pathogens identified by the WHO. In this review we identified sources for molecular and serological diagnostic tests used in MERS-CoV detection, case management and outbreak investigations, as well as surveillance for humans and animals (camels), and summarised the performance of currently available tests, diagnostic needs, and associated challenges for diagnostic test development and implementation. A more detailed understanding of the kinetics of infection of MERS-CoV is needed in order to optimise the use of existing assays. Notably, MERS-CoV point-of-care tests are needed in order to optimise supportive care and to minimise transmission risk. However, for new test development, sourcing clinical material continues to be a major challenge to achieving assay validation. Harmonisation and standardisation of laboratory methods are essential for surveillance and for a rapid and effective international response to emerging diseases. Routine external quality assessment, along with well-characterised and up-to-date proficiency panels, would provide insight into MERS-CoV diagnostic performance worldwide. A defined set of Target Product Profiles for diagnostic technologies will be developed by WHO to address these gaps in MERS-CoV outbreak management.
诊断在疫情的早期发现和控制中发挥着核心作用，并且能够使人们对中东呼吸综合征冠状病毒（MERS-CoV）的疾病动力学和风险因素有更细致入微的了解，MERS-CoV是世界卫生组织确定的重点病原体之一。在本综述中，我们确定了用于MERS-CoV检测、病例管理和疫情调查以及人类和动物（骆驼）监测的分子和血清学诊断检测的来源，并总结了现有检测的性能、诊断需求以及诊断检测开发和实施的相关挑战。为了优化现有检测方法的使用，需要对MERS-CoV的感染动力学有更详细的了解。值得注意的是，需要MERS-CoV即时检测以优化支持性护理并将传播风险降至最低。然而，对于新检测方法的开发，获取临床材料仍然是实现检测验证的主要挑战。实验室方法的协调和标准化对于监测以及对新发疾病做出快速有效的国际应对至关重要。常规外部质量评估以及特征明确且最新的能力验证专家组将有助于了解全球范围内MERS-CoV的诊断性能。世界卫生组织将制定一套明确的诊断技术目标产品简介，以解决MERS-CoV疫情管理中的这些差距。
