Development and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever.

IF 9.7 1区医学 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

EBioMedicine Pub Date : 2024-12-01 Epub Date: 2024-11-20 DOI:10.1016/j.ebiom.2024.105460

Caitlin R Thompson, Ilkay Bozkurt, Yasemin Cosgun, Patricia Blundell, Annelyse Duvoix, Michael Johnson, Hakan Hedef, Fatma Gonca Arslan, Busra Ayyildiz Umudum, Heval Can Bilek, Esra Tanyel, Ayşe Nur Pektaş, Tuba Nur Taşseten, Mehmet Bakir, Seyit Ali Büyüktuna, Yildiz Olçar, Feray Aycan Yilmaz, Mustafa Arslan, Riyadh A Al-Hilfi, Hussein Alwan Hasan, Raghad Ibrahim Khaleel, Iman M Aufi, Sinan Ghazi Mahdi, Ihab R Aakef, Hawraa A Shakir, Ahmed A Hussein, Noora A Abdulhadi, Zainb A Mohsin, Gulay Korukluoglu, Ana I Cubas Atienzar, Tom E Fletcher, Emily Adams

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引用次数: 0

Abstract

Background: Crimean-Congo Haemorrhagic Fever (CCHF) is a viral haemorrhagic fever with a case fatality rate of 5-25% that has been prioritised for research and development by the World Health Organisation. There are no CCHF rapid diagnostic tests (RDTs) commercially available. We describe the development and evaluation of an antigen-targeting lateral flow immunoassay RDT for CCHF.

Methods: Prospective clinical samples were collected and tested between July and October 2023 in Türkiye. Retrospective stored samples were obtained from the Central Public Health Laboratory, Baghdad, Iraq. The sensitivity and specificity of the CCHF RDT was compared to reverse transcription quantitative polymerase chain reaction assays.

Findings: On prospective clinical samples in Türkiye, the sensitivity and specificity of the CCHF RDT was 90.4% [95% CI 81.5-95.3%] (n = 73) and 96.2% [95% CI 87.0-99.3%] (n = 52), respectively with a sensitivity of 92.9% [95% CI 84.3-96.9%] (n = 70) in samples with a cycle threshold (Ct) ≤30. On retrospective stored samples in Iraq, sensitivity and specificity of the RDT was 71.7% [95% CI 59.2-81.5%] (n = 60) and 92.5% [95% CI 80.1-97.8%] (n = 40), respectively with a sensitivity of 82.2% [95% CI 68.7-90.7%] (n = 45) in samples of Ct ≤30.

Interpretation: The CCHF RDT was an effective rapid diagnostic test in this preliminary clinical evaluation, showing this RDT has the potential diagnostic capability for use at the point-of-care. Definitive evaluation is now required to ensure the RDT meets the regulatory requirements for commercialisation.

Funding: The Liverpool School of Tropical Medicine, National Institute for Health Research Health Protection Research Unit in Emerging Zoonotic Infections, The Medical Research Council and The Pandemic Institute.

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开发和评估克里米亚-刚果出血热抗原靶向侧流试验。

背景：克里米亚-刚果出血热（CCHF克里米亚-刚果出血热（CCHF）是一种病毒性出血热，病死率为 5%-25%，已被世界卫生组织列为优先研发项目。目前还没有商业化的 CCHF 快速诊断测试 (RDT)。我们介绍了抗原靶向侧流免疫测定 CCHF RDT 的开发和评估情况：方法：2023 年 7 月至 10 月期间在土耳其收集并检测了前瞻性临床样本。回顾性储存样本来自伊拉克巴格达中央公共卫生实验室。将 CCHF RDT 的灵敏度和特异性与反转录定量聚合酶链反应检测进行了比较：在土耳其的前瞻性临床样本中，CCHF RDT 的灵敏度和特异性分别为 90.4% [95% CI 81.5-95.3%] (n = 73) 和 96.2% [95% CI 87.0-99.3%] (n = 52)，在周期阈值 (Ct) ≤30 的样本中，灵敏度为 92.9% [95% CI 84.3-96.9%] (n = 70)。在伊拉克的回顾性储存样本中，RDT 的灵敏度和特异性分别为 71.7% [95% CI 59.2-81.5%] (n = 60) 和 92.5% [95% CI 80.1-97.8%] (n = 40)，在 Ct ≤30 的样本中灵敏度为 82.2% [95% CI 68.7-90.7%] (n = 45)：在此次初步临床评估中，CCHF 快速诊断试剂盒是一种有效的快速诊断试剂盒，表明该试剂盒具有在医疗点使用的潜在诊断能力。现在需要进行最终评估，以确保RDT符合商业化的监管要求：资金来源：利物浦热带医学院、国家健康研究所新兴动物传染病健康保护研究组、医学研究委员会和大流行病研究所。

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来源期刊

EBioMedicine Biochemistry, Genetics and Molecular Biology-General Biochemistry,Genetics and Molecular Biology

CiteScore

17.70

自引率

0.90%

发文量

579

审稿时长

5 weeks

期刊介绍： eBioMedicine is a comprehensive biomedical research journal that covers a wide range of studies that are relevant to human health. Our focus is on original research that explores the fundamental factors influencing human health and disease, including the discovery of new therapeutic targets and treatments, the identification of biomarkers and diagnostic tools, and the investigation and modification of disease pathways and mechanisms. We welcome studies from any biomedical discipline that contribute to our understanding of disease and aim to improve human health.