Evaluation of an Innovative Rapid Diagnostic Test for Human Strongyloidiasis to Detect Specific IgG Antibody in 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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Penchom Janwan Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;
Department of Medical Technology, School of Allied Health Sciences, Walailak University, Nakhon Si Thammarat, 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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Rutchanee Rodpai Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;
Department of Medical Technology, Faculty of Allied Health Sciences, Nakhonratchasima College, Nakhon Ratchasima, 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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Tongjit Thanchomnang Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen, Thailand;
Faculty of Medicine, Mahasarakham University, Maha Sarakham, Thailand

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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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Human strongyloidiasis is an important intestinal parasitic disease that affects public health globally and is transmitted through contact with infective larvae on contaminated soil. Immunocompromised hosts can experience hyperinfection, which can lead to fatal systemic strongyloidiasis. Here, an innovative point-of-care (POC) test kit, the strongyloidiasis immunochromatographic blood test (the NIE-SsIR whole-blood ICT) kit is described. The kit was used to detect anti-Strongyloides IgG antibody in whole-blood samples (WBSs) instead of serum to diagnose strongyloidiasis. The kit is based on a mixture of two recombinant Strongyloides stercoralis protein antigens (NIE and SsIR) and colloidal-gold-labeled conjugates of anti-human IgG antibody to evaluate diagnostic values with simulated and fresh anticoagulated WBSs. The NIE-SsIR whole-blood ICT kit showed potentially high diagnostic values with simulated WBSs, obtained by spiking patients’ sera with red blood cells. The sensitivity, specificity, and positive and negative predictive values were 93.0%, 93.7%, 88.6%, and 96.2%, respectively, at the prevalence of disease simulated under the laboratory conditions of 34.5%. In addition, 18 of 20 fresh anticoagulated WBSs from strongyloidiasis cases were positive, and all 15 WBSs from healthy volunteers were negative. The NIE-SsIR whole-blood ICT kit is a simple and convenient POC testing tool and can possibly be used with fingerstick blood samples, thereby not requiring the drawing of venous blood and separation of the serum. The NIE-SsIR whole-blood ICT kit can assist clinical diagnosis in remote areas and field settings without sophisticated equipment.

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Author Notes

Financial support: This project was funded by grants from the National Research Council of Thailand (NRCT): High-Potential Research Team Grant Program (contract no. N42A670561 to W. Maleewong); the Research Program from Research and Graduate Studies, Khon Kaen University (KKU) (grant no. RP66-7-001 to 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 KKU.

Current contact information: Patcharaporn Boonroumkaew, Lakkhana Sadaow, 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, oransa@kku.ac.th, pewpan@kku.ac.th, and wanch_ma@kku.ac.th. Penchom Janwan, Department of Medical Technology, School of Allied Health Sciences, Walailak University, Nakhon Si Thammarat, Thailand, E-mail: pair.wu@gmail.com. Rutchanee Rodpai Department of Medical Technology, Faculty of Allied Health Sciences, Nakhonratchasima College, Nakhon Ratchasima, Thailand, E-mail: rutchanee5020@gmail.com. Tongjit Thanchomnang Faculty of Medicine, Mahasarakham University, Maha Sarakham, Thailand, E-mail: tthanchomnang@gmail.com.

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
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