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.

Crimean-Congo出血热（CCHF）是一个世界卫生组织（WHO），因为其死亡率很高，缺乏疫苗以及有效的治疗和诊断，因此列出了优先疾病。 CCHF患者的死亡率很高，只有一种抗病毒只有在疾病早期服用时才有效。但是，当前的CCHF诊断测试结果周转速度缓慢，延迟为2-5天，导致治疗功效降低和患者康复差。 WHO已将快速诊断CCHF诊断的快速诊断测试（RDT）的开发确定为优先事项。 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 环境。 GADX将对制造技术进行更高的尺度，包括批量结合，并在其质量管理系统中使用质量控制系统，以确保RDT保留其在批处理之间的原始性能以及以商业量制造时。我们将进行市场范围的练习，以识别客户并通过此重要RDT的机制来推销机制。我们将使用所有套件组件进行评估的所有套件组件设计。首先，我们将与英国卫生安全局（UKHSA）进行所有CCHF病毒谱系的分析评估，然后在此之后，我们将评估土耳其卫生部（MOH）和伊拉克疾病控制与预防中心（MOH）的银行样本中的RDT。此外，与MOH合作，LSTM将建立临床试验，以在土耳其CCHF高流动性地区的492名患者中对RDT进行诊断评估。这些试验的数据将用于制备UKCA标记下的监管提交。