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

Caitlin Thompson; Ilkay Bozkurt; Yasemin Cosgun; Pat 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 Fletcher; Emily Adams

doi:10.1016/j.ebiom.2024.105460

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

Caitlin Thompson
, Ilkay Bozkurt
, Yasemin Cosgun
, Pat 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 Fletcher, Emily Adams

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

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.

Original language	English
Article number	105460
Pages (from-to)	105460
Journal	eBioMedicine
Volume	110
Early online date	20 Nov 2024
DOIs	https://doi.org/10.1016/j.ebiom.2024.105460
Publication status	Published - 20 Nov 2024

Keywords

CCHF
Crimean-Congo Haemorrhagic Fever
Lateral flow test
Rapid diagnostic test
RDT

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ebiom.2024.105460Licence: CC BY-NC-ND

PIIS2352396424004961Final published version, 659 KBLicence: CC BY-NC-ND

Cite this

Thompson, C., Bozkurt, I., Cosgun, Y., Blundell, P., Duvoix, A., Johnson, M., Hedef, H., Arslan, F. G., Umudum, B. A., Bilek, H. C., Tanyel, E., Pektaş, A. N., Taşseten, T. N., Bakir, M., Büyüktuna, S. A., Olçar, Y., Yilmaz, F. A., Arslan, M., Al-hilfi, R. A., ... Adams, E. (2024). Development and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever. eBioMedicine, 110, 105460. Article 105460. https://doi.org/10.1016/j.ebiom.2024.105460

@article{7986e8519c27462c8dd2d55834a03bd1,

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

abstract = "BackgroundCrimean-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. MethodsProspective clinical samples were collected and tested between July and October 2023 in T{\"u}rkiye. 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. FindingsOn prospective clinical samples in T{\"u}rkiye, 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. InterpretationThe 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. FundingThe 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.",

keywords = "CCHF, Crimean-Congo Haemorrhagic Fever, Lateral flow test, Rapid diagnostic test, RDT",

author = "Caitlin Thompson and Ilkay Bozkurt and Yasemin Cosgun and Pat Blundell and Annelyse Duvoix and Michael Johnson and Hakan Hedef and Arslan, \{Fatma Gonca\} and Umudum, \{Busra Ayyildiz\} and Bilek, \{Heval Can\} and Esra Tanyel and Pekta{\c s}, \{Ay{\c s}e Nur\} and Ta{\c s}seten, \{Tuba Nur\} and Mehmet Bakir and B{\"u}y{\"u}ktuna, \{Seyit Ali\} and Yildiz Ol{\c c}ar and Yilmaz, \{Feray Aycan\} and Mustafa Arslan and Al-hilfi, \{Riyadh A.\} and Hasan, \{Hussein Alwan\} and Khaleel, \{Raghad Ibrahim\} and Aufi, \{Iman M.\} and Mahdi, \{Sinan Ghazi\} and Aakef, \{Ihab R.\} and Shakir, \{Hawraa A.\} and Hussein, \{Ahmed A.\} and Abdulhadi, \{Noora A.\} and Mohsin, \{Zainb A.\} and Gulay Korukluoglu and \{Cubas Atienzar\}, \{Ana I.\} and Tom Fletcher and Emily Adams",

year = "2024",

month = nov,

day = "20",

doi = "10.1016/j.ebiom.2024.105460",

language = "English",

volume = "110",

pages = "105460",

journal = "eBioMedicine",

issn = "2352-3964",

publisher = "Elsevier B.V.",

}

Thompson, C , Bozkurt, I, Cosgun, Y, Blundell, P, Duvoix, A, Johnson, M, Hedef, H, Arslan, FG, Umudum, BA, Bilek, HC, Tanyel, E, Pektaş, AN, Taşseten, TN, Bakir, M, Büyüktuna, SA, Olçar, Y, Yilmaz, FA, Arslan, M, Al-hilfi, RA, Hasan, HA, Khaleel, RI, Aufi, IM, Mahdi, SG, Aakef, IR, Shakir, HA, Hussein, AA, Abdulhadi, NA, Mohsin, ZA, Korukluoglu, G, Cubas Atienzar, AI , Fletcher, T & Adams, E 2024, 'Development and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever', eBioMedicine, vol. 110, 105460, pp. 105460. https://doi.org/10.1016/j.ebiom.2024.105460

TY - JOUR

T1 - Development and evaluation of an antigen targeting lateral flow test for Crimean-Congo Haemorrhagic Fever

AU - Thompson, Caitlin

AU - Bozkurt, Ilkay

AU - Cosgun, Yasemin

AU - Blundell, Pat

AU - Duvoix, Annelyse

AU - Johnson, Michael

AU - Hedef, Hakan

AU - Arslan, Fatma Gonca

AU - Umudum, Busra Ayyildiz

AU - Bilek, Heval Can

AU - Tanyel, Esra

AU - Pektaş, Ayşe Nur

AU - Taşseten, Tuba Nur

AU - Bakir, Mehmet

AU - Büyüktuna, Seyit Ali

AU - Olçar, Yildiz

AU - Yilmaz, Feray Aycan

AU - Arslan, Mustafa

AU - Al-hilfi, Riyadh A.

AU - Hasan, Hussein Alwan

AU - Khaleel, Raghad Ibrahim

AU - Aufi, Iman M.

AU - Mahdi, Sinan Ghazi

AU - Aakef, Ihab R.

AU - Shakir, Hawraa A.

AU - Hussein, Ahmed A.

AU - Abdulhadi, Noora A.

AU - Mohsin, Zainb A.

AU - Korukluoglu, Gulay

AU - Cubas Atienzar, Ana I.

AU - Fletcher, Tom

AU - Adams, Emily

PY - 2024/11/20

Y1 - 2024/11/20

N2 - BackgroundCrimean-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. MethodsProspective 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. FindingsOn 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. InterpretationThe 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. FundingThe 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.

AB - BackgroundCrimean-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. MethodsProspective 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. FindingsOn 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. InterpretationThe 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. FundingThe 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.

KW - CCHF

KW - Crimean-Congo Haemorrhagic Fever

KW - Lateral flow test

KW - Rapid diagnostic test

KW - RDT

U2 - 10.1016/j.ebiom.2024.105460

DO - 10.1016/j.ebiom.2024.105460

M3 - Article

SN - 2352-3964

VL - 110

SP - 105460

JO - eBioMedicine

JF - eBioMedicine

M1 - 105460

ER -

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

Abstract

Keywords

UN SDGs

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