Article Category:
Research Article

Lateral-Flow Antibody Detection Device for the Diagnosis of Human Fascioliasis Using Simulated Whole-Blood Samples

Patcharaporn Boonroumkaew Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand;
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Lakkhana Sadaow Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand;
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Nongnapas Kanchanangkul Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Rutchanee Rodpai Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand;
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Oranuch Sanpool Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand;
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Hiroshi Yamasaki Department of Parasitology, National Institute of Infectious Diseases, Tokyo, Japan;
Department of Tropical Medicine and Parasitology, School of Medicine, Juntendo University, Tokyo, Japan

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Pewpan M. Intapan Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand;
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Wanchai Maleewong Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand;
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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DOI:
https://doi.org/10.4269/ajtmh.24-0754
Volume/Issue:
Ahead of Print
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Fascioliasis, which is caused by Fasciola hepatica and Fasciola gigantica (F. gigantica), is a public health problem worldwide. Stages infective to humans occur on aquatic plants and in water. The gold standard for diagnosing human infection depends on finding fluke eggs in stool samples. However, this method has low diagnostic sensitivity; eggs from other trematode species might be misidentified as those of Fasciola, and eggs are not voided in ectopic infections. Therefore, serological analysis can support the diagnosis of human fascioliasis. We evaluated whether a new fascioliasis immunochromatographic test kit, which detects specific IgG antibodies using F. gigantica excretory–secretory antigen, can be used for rapid diagnosis from whole blood. The kit (“the fascioliasis whole-blood test kit”) was evaluated under laboratory conditions using 250 whole-blood samples (WBSs), of which 41 were from fascioliasis cases. Results based on simulated WBSs and the corresponding serum samples were compared and showed almost perfect agreement (percent agreement = 97.2%; kappa value = 0.9145). The diagnostic sensitivity and specificity of the test using simulated WBSs were 97.6% and 96.2%, respectively. Comparable values when serum samples were tested were 100.0% and 93.3%, respectively. This kit represents a significant advance because it does not require extensive training of personnel, is easy to use, and can support diagnosis at the bedside or in local and remote hospitals with limited facilities. The kit may also contribute significantly to epidemiological surveys.

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Author Notes

Financial support: This project was funded by grants from the National Research Council of Thailand (NRCT) through the High-Potential Research Team Grant Program (contract no. N42A670561 to W. Maleewong), the Research Program from Research and Graduate Studies at Khon Kaen University (grant no. RP66-7-001 to W. Maleewong), the Office of the Ministry of Higher Education, Science, Research, and Innovation under the Reinventing University 2024 Visiting Professor Program (W. Maleewong), and a scholarship under the Post Doctoral Training for Frontier Research from Khon Kaen University, Thailand (grant no. PD2568-01 to P. Boonroumkaew and W. Maleewong). The contents of this report are solely the responsibility of the authors and do not necessarily represent the official views of the NRCT and Khon Kaen University.

Disclosure: The ethical guidelines and principles of the Declaration of Helsinki guided all study procedures. The Ethics Committee for Human Research at Khon Kaen University (HE664044) and the Medical Ethics Committee of the National Institute of Infectious Diseases in Tokyo, Japan (No. 177) approved the use of human sera. All data were fully anonymized, and the Human Ethics Committee waived the requirement for informed consent.

Current contact information: Patcharaporn Boonroumkaew, Lakkhana Sadaow, Nongnapas Kanchanangkul, Rutchanee Rodpai, Oranuch Sanpool, Pewpan M. Intapan, and Wanchai Maleewong, Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand, E-mails: hamooploy@gmail.com, sadaow1986@gmail.com, nongnapas.kanch@gmail.com, rutchanee5020@gmail.com, oransa@kku.ac.th, pewpan@kku.ac.th, and wanch_ma@kku.ac.th. Hiroshi Yamasaki, Department of Parasitology, National Institute of Infectious Diseases, Tokyo, Japan, E-mails: hyamasak@niid.go.jp.

Address correspondence to Wanchai Maleewong, Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand. E-mail: wanch_ma@kku.ac.th
Copyright:
© American Society of Tropical Medicine and Hygiene 2025
Received:
10 Nov 2024
|
Accepted:
03 Dec 2024
|
Published Online:
11 Feb 2025
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645

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