Thompson Caitlin R, Bozkurt Ilkay, Cosgun Yasemin, Blundell Patricia, Duvoix Annelyse, Johnson Michael, Hedef Hakan, Arslan Fatma Gonca, Umudum Busra Ayyildiz, Bilek Heval Can, Tanyel Esra, Pektaş Ayşe Nur, Taşseten Tuba Nur, Bakir Mehmet, Büyüktuna Seyit Ali, Olçar Yildiz, Yilmaz Feray Aycan, Arslan Mustafa, Al-Hilfi Riyadh A, Hasan Hussein Alwan, Khaleel Raghad Ibrahim, Aufi Iman M, Mahdi Sinan Ghazi, Aakef Ihab R, Shakir Hawraa A, Hussein Ahmed A, Abdulhadi Noora A, Mohsin Zainb A, Korukluoglu Gulay, Cubas Atienzar Ana I, Fletcher Tom E, Adams Emily
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom; Department of Clinical Microbiology and Infectious Diseases, Ondokuz Mayis University School of Medicine, Samsun, Türkiye.
EBioMedicine. 2024 Dec;110:105460. doi: 10.1016/j.ebiom.2024.105460. Epub 2024 Nov 20.
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.
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.
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.
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.
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.
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%，世界卫生组织已将其列为研发重点。目前尚无商业化的CCHF快速诊断检测（RDT）。我们描述了一种针对CCHF的抗原靶向侧流免疫分析RDT的开发和评估。
2023年7月至10月在土耳其收集并检测前瞻性临床样本。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的敏感性和特异性与逆转录定量聚合酶链反应检测进行比较。
在土耳其的前瞻性临床样本中，CCHF RDT的敏感性和特异性分别为90.4%[95%置信区间81.5%-95.3%]（n = 73）和96.2%[95%置信区间87.0%-99.3%]（n = 52），在循环阈值（Ct）≤30的样本中敏感性为92.9%[95%置信区间84.3%-96.9%]（n = 70）。在伊拉克的回顾性储存样本中，RDT的敏感性和特异性分别为71.7%[95%置信区间59.2%-81.5%]（n = 60）和92.5%[95%置信区间80.1%-97.8%]（n = 40），在Ct≤30的样本中敏感性为82.2%[95%置信区间68.7%-90.7%]（n = 45）。
在这项初步临床评估中，CCHF RDT是一种有效的快速诊断检测，表明该RDT具有在护理点使用的潜在诊断能力。现在需要进行确定性评估，以确保RDT符合商业化的监管要求。
利物浦热带医学院、国家卫生研究院新兴人畜共患感染健康保护研究组、医学研究理事会和大流行研究所。
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