Development of an Immunochromatographic Point-of-Care Test for Serodiagnosis of Opisthorchiasis and Clonorchiasis

Lakkhana Sadaow Department of Parasitology, Faculty of Medicine and Research and Diagnostic Center for Emerging Infectious Diseases, Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Oranuch Sanpool Department of Parasitology, Faculty of Medicine and Research and Diagnostic Center for Emerging Infectious Diseases, Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Rutchanee Rodpai Department of Parasitology, Faculty of Medicine and Research and Diagnostic Center for Emerging Infectious Diseases, 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, Ministry of Health, Labour and Welfare, Tokyo, Japan;

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Wannaporn Ittiprasert Department of Microbiology, Immunology and Tropical Medicine, Research Center for Neglected Diseases of Poverty, School of Medicine and Health Science, George Washington University, Washington, District of Columbia

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Victoria H. Mann Department of Microbiology, Immunology and Tropical Medicine, Research Center for Neglected Diseases of Poverty, School of Medicine and Health Science, George Washington University, Washington, District of Columbia

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Paul J. Brindley Department of Microbiology, Immunology and Tropical Medicine, Research Center for Neglected Diseases of Poverty, School of Medicine and Health Science, George Washington University, Washington, District of Columbia

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Wanchai Maleewong Department of Parasitology, Faculty of Medicine and Research and Diagnostic Center for Emerging Infectious Diseases, Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Pewpan M. Intapan Department of Parasitology, Faculty of Medicine and Research and Diagnostic Center for Emerging Infectious Diseases, Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;

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Chronic infections with the food-borne liver flukes, Opisthorchis viverrini or Clonorchis sinensis, associate with cholangiocarcinoma, bile duct cancer, which generally has a poor prognosis. We have produced a rapid and simple immunochromatographic test (ICT) kit for the diagnosis of opisthorchiasis and clonorchiasis by the detection of IgG antibodies in human infection sera. Sera from volunteers with proven opisthorchiasis and several other parasitic diseases and from healthy controls were evaluated for the presence of liver fluke infection–specific antibodies using a preparation of excretory–secretory antigen from adult stage O. viverrini absorbed onto ICT strips. Diagnostic values were compared with an ELISA. The diagnostic sensitivity, specificity, and positive and negative predictive values of the ELISA were 100%, 98.3%, 97.9%, and 100%, whereas those for the ICT were 94.6%, 91.2%, 89.7%, and 95.4%, respectively. There was 91.7% concordance between the ICT with ELISA, and differences in performance between the tests were not statistically significant (P > 0.05). Twenty-seven of 30 (90%) of the clonorchiasis sera also were positive by ICT. This new ICT provides a facile, rapid test for point-of-care testing tool, which can be used at the bedside without the need for sophisticated equipment. Moreover, the ICT can be anticipated to supplement stool examination as a screening tool in the clinic for the diagnosis of opisthorchiasis and clonorchiasis, and in addition, it may be useful in screens of populations at risk of liver fluke infection–associated cholangiocarcinoma.

Author Notes

Address correspondence to Paul J. Brindley, Department of Microbiology, Immunology and Tropical Medicine, Research Center for Neglected Diseases of Poverty, School of Medicine and Health Science, George Washington University, Washington, DC 20052, E-mail: pbrindley@email.gwu.edu or Pewpan M. Intapan, Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand, E-mail: pewpan@kku.ac.th.

Financial support: This study was supported by Distinguished Research Professor Grant, Thailand Research Fund (TRF), grant no. DPG 6280002, and Khon Kaen University (P. M. I., W. M.), a scholarship under the Doctoral Training Program of the Graduate School and Research Affairs, Khon Kaen University (KKU), grant no 60164 (L. S.), and by award no. RO1CA164719 (P. J. B., P. M. I.) from the National Cancer Institute, National Institutes of Health (NIH), United States. The contents of this report are solely the responsibility of the authors and do not necessarily represent the official views of the TRF, KKU, or the NIH.

Authors’ addresses: Lakkhana Sadaow, Oranuch Sanpool, Rutchanee Rodpai, Wanchai Maleewong, and Pewpan M. Intapan, Department of Parasitology, Faculty of Medicine and Research and Diagnostic Center for Emerging Infectious Diseases, Khon Kaen University, Khon Kaen, Thailand, E-mails: sadaow1986@gmail.com, oransa@kku.ac.th, rutchanee5020@gmail.com, wanch_ma@kku.ac.th, and pewpan@kku.ac.th. Hiroshi Yamasaki, Department of Parasitology, National Institute of Infectious Diseases, Ministry of Health, Labor and Welfare, Tokyo, Japan, E-mail: hyamasak@niid.go.jp. Wannaporn Ittiprasert, Victoria H. Mann, and Paul J. Brindley, Department of Microbiology, Immunology and Tropical Medicine, Research Center for Neglected Diseases of Poverty, School of Medicine and Health Science, George Washington University, Washington, DC, E-mails: wannaporni@gwu.edu, vmann@gwu.edu, and pbrindley@gwu.edu.

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