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

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dc.authoridCubas Atienzar, Ana Isabel/0000-0002-9604-124X
dc.authoridKorukluoglu, Gulay/0000-0001-7625-6350
dc.authoridCosgun, Yasemin/0000-0002-3815-8036
dc.authoridBilek, Heval Can/0000-0002-4330-3293
dc.authoridThompson, Caitlin/0000-0003-1763-8863
dc.contributor.authorThompson, Caitlin R.
dc.contributor.authorBozkurt, Ilkay
dc.contributor.authorCosgun, Yasemin
dc.contributor.authorBlundell, Patricia
dc.contributor.authorDuvoix, Annelyse
dc.contributor.authorJohnson, Michael
dc.contributor.authorHedef, Hakan
dc.date.accessioned2025-05-04T16:47:13Z
dc.date.available2025-05-04T16:47:13Z
dc.date.issued2024
dc.departmentSivas Cumhuriyet Üniversitesi
dc.description.abstractBackground 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 antigentargeting lateral flow immunoassay RDT for CCHF. Methods Prospective clinical samples were collected and tested between July and October 2023 in Turkiye. 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 Turkiye, 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.
dc.description.sponsorshipLiverpool School of Tropical Medicine; National Institute for Health Research Health Protection Research Unit in Emerging Zoonotic Infections; Medical Research Council; Pandemic Institute
dc.description.sponsorshipThe 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.
dc.identifier.doi10.1016/j.ebiom.2024.105460
dc.identifier.issn2352-3964
dc.identifier.pmid39571306
dc.identifier.scopus2-s2.0-85209590439
dc.identifier.scopusqualityQ1
dc.identifier.urihttps://doi.org/10.1016/j.ebiom.2024.105460
dc.identifier.urihttps://hdl.handle.net/20.500.12418/35534
dc.identifier.volume110
dc.identifier.wosWOS:001376787900001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherElsevier
dc.relation.ispartofEbiomedicine
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.snmzKA_WOS_20250504
dc.subjectCrimean-Congo Haemorrhagic Fever
dc.subjectCCHF
dc.subjectRapid diagnostic test
dc.subjectRDT
dc.subjectLateral flow test
dc.titleDevelopment and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever
dc.typeArticle

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