ICF: Development of a rapid diagnostic test to identify Crimean-Congo Haemorrhagic Fever at the point-of-care

ICF：开发快速诊断测试以在护理点识别克里米亚-刚果出血热

• 批准号: MR/Y019431/1
• 负责人: Ana Isabel Cubas Atienzar
• 金额: $ 166.93万
• 依托单位: Liverpool School of Tropical Medicine
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY019431%2F1
• 关键词: ICF; Development; rapid; diagnostic; test

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.

克里米亚-刚果出血热 (CCHF) 由于死亡率高且缺乏疫苗以及有效的治疗和诊断，被世界卫生组织 (WHO) 列为重点疾病。 CCHF 患者的死亡率很高，而且只有一种抗病毒药物只有在疾病早期使用才可能有效。然而，目前CCHF诊断检测结果的周转速度较慢，延迟了2-5天，导致治疗效果下降和患者恢复不佳。 WHO 已将开发用于快速诊断 CCHF 的快速诊断测试 (RDT) 列为优先事项。该提案旨在满足这一需求，利物浦热带医学院 (LSTM) 与 Global Access Diagnostics (GADx) 合作开发了第一个 RDT 原型，用于诊断 CCHF，其敏感性和特异性满足 WHO 的建议： RDTs.LSTM 与 GADx 合作将优化 RDT，以在 ISO 认证的环境中提高灵敏度和特异性。 GADx 将实施大规模制造技术，包括批量偶联，并在其质量管理系统中使用质量控制系统，以确保 RDT 在批次之间和商业批量生产时保持其原始性能。我们将进行市场范围界定工作，以确定客户并通过机制将这一重要的 RDT 推向市场。我们将设计锁定产品与所有套件组件以进行评估。首先，我们将与英国卫生安全局 (UKHSA) 一起对所有 CCHF 病毒谱系进行分析评估，随后我们将评估土耳其卫生部 (MoH) 和疾病控制与预防中心储存样本中的 RDT（ CDC）在伊拉克。此外，LSTM 将与卫生部合作，在土耳其 CCHF 高流行地区的 492 名二级卫生诊所就诊的患者中开展 RDT 诊断评估临床试验。这些试验的数据将用于根据 UKCA 标记准备监管提交。