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Thompson, Caitlin, 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, CubasAtienzar, Ana, Fletcher, Tom and Adams, Emily 
ORCID: https://orcid.org/0000-0002-0816-2835
(2024)
'Development and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever'. EBioMedicine, Vol 110, p. 105460.
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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.
| Item Type: | Article |
|---|---|
| Subjects: | WC Communicable Diseases > Virus Diseases > General Virus Diseases > WC 500 Virus diseases (General or not elsewhere classified) WC Communicable Diseases > Virus Diseases > Viral Hemorrhagic Fevers. Other Virus Diseases > WC 540 Neurotropic virus diseases |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1016/j.ebiom.2024.105460 |
| SWORD Depositor: | JISC Pubrouter |
| Depositing User: | JISC Pubrouter |
| Date Deposited: | 25 Nov 2024 13:58 |
| Last Modified: | 04 Dec 2024 09:08 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/25659 |
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