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Effectiveness of Fasciola gigantica excretory-secretory and recombinant cathepsin L antigens for rapid diagnosis of human fascioliasis using immunochromatographic devices

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Abstract

Fascioliasis, a food- and water-borne trematodiasis, has been identified as a public health threat by the World Health Organization, with millions of people estimated to be infected or at risk of infection worldwide. We developed an immunochromatographic test (ICT) as a point-of-care (POC) tool for the rapid serodiagnosis of human fascioliasis caused by Fasciola gigantica and evaluated their diagnostic ability. Two tests were developed using antigens from adult F. gigantica excretory-secretory (ES) product and recombinant F. gigantica cathepsin L (rFgCL). Sera from 12 patients with parasitologically proven fascioliasis caused by F. gigantica, 18 with clinically suspected fascioliasis, 65 with other parasitic infections, and 30 healthy controls were used. Using a cutoff of > 0.5 for antibody detection, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the ES-based ICT method were 100%, 98.9% 96.8%, 100%, and 99.2%, respectively, and those of the rFgCL-based ICT method were 86.7%, 93.7%, 81.3%, 95.7%, and 92.0%, respectively. The concordance between the two methods was 91.2%. Tests using F. gigantica ES and rFgCL antigens can be employed quickly and easily as POC diagnostic tools. They can be used to support the clinical diagnosis of human fascioliasis gigantica and in large-scale surveys in endemic areas throughout tropical regions without necessitating additional facilities or ancillary supplies.

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Acknowledgments

We would like to thank Dylan Southard through Khon Kaen University Publication Clinic (Thailand) for the English editing of this manuscript. We also extend our gratitude to Jitaporn Harasan from the Mekong Health Science Research Institute for providing such an effective immunochromatographic technique.

Funding

This study was supported by a Distinguished Research Professor Grant from the Thailand Research Fund (grant no. DPG6280002) awarded to P.M.I. and W.M., scholarships provided to L.S. under the Khon Kaen University Post-Doctoral Training Program of the Graduate School and Research Affairs (grant no 60164), Faculty of Medicine, Khon Kaen University to O.S. and W.M. (grant no. DR63101), and Research Program on Emerging and Re-Emerging Infectious Diseases from the Japan Agency for Medical Research and Development (Kansensho Jitsuyoka-Ippan grant nos. JP17fk0108119, JP18fk0108046, JP19fk0108046) to Y.M.

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Authors

Contributions

Conceptualization: LS, HY, WM, and PMI.

Methodology: LS, HY, YM, OS, RR, PJ, and PB.

Formal analysis and investigation: LS, HY, YM, PB, WM, and PMI.

Writing-original draft preparation: LS, HY, YM, OS, RR, PJ, PB, and PMI.

Writing-review and editing: LS, HY, PJ, WM, and PMI.

Supervision: HY, WM, and PMI.

All authors read and approved the final manuscript.

Corresponding author

Correspondence to Pewpan M. Intapan.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standards

This study was performed in compliance with all relevant regulations and guidance. The study protocol was approved by the Khon Kaen University Ethics Committee for Human Research (HE611507) with the relevant guidelines and regulations regarding ethical principles for medical research involving human subjects detailed in the Declaration of Helsinki. Informed consent was obtained from adult participants and from parents or legal guardians of minors. The use of human sera was approved by the Medical Ethics Committee of the National Institute of Infectious Diseases (Tokyo, Japan; No. 177). Experiments involving the use of vertebrate animals were approved by the Khon Kaen University Animal Ethics Committee according to the National Research Council of Thailand’s animal experimentation ethics regulations (AEMDKKU 002/2018).

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Section Editor: Xing-Quan ZHU

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Sadaow, L., Yamasaki, H., Morishima, Y. et al. Effectiveness of Fasciola gigantica excretory-secretory and recombinant cathepsin L antigens for rapid diagnosis of human fascioliasis using immunochromatographic devices. Parasitol Res 119, 3691–3698 (2020). https://doi.org/10.1007/s00436-020-06907-w

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