Development of Immunochromatographic Test Kit for Rapid Detection of Specific IgG4 Antibody in Whole-Blood Samples for Diagnosis of Human Gnathostomiasis
Penchom Janwan,
Pewpan M. Intapan,
Lakkhana Sadaow,
Rutchanee Rodpai,
Hiroshi Yamasaki,
Patcharaporn Boonroumkaew,
Oranuch Sanpool,
Tongjit Thanchomnang,
Phuangphaka Sadee,
Wanchai Maleewong
Affiliations
Penchom Janwan
Department of Medical Technology, School of Allied Health Sciences, Walailak University, Nakhon Si Thammarat 80161, Thailand
Pewpan M. Intapan
Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Lakkhana Sadaow
Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Rutchanee Rodpai
Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Hiroshi Yamasaki
Department of Parasitology, National Institute of Infectious Diseases, Tokyo 162-8640, Japan
Patcharaporn Boonroumkaew
Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Oranuch Sanpool
Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Tongjit Thanchomnang
Mekong Health Science Research Institute, Khon Kaen University, Khon Kaen 40002, Thailand
Phuangphaka Sadee
Clinical Immunology Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Wanchai Maleewong
Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand
Human gnathostomiasis is a harmful food-borne zoonosis caused by roundworms of the genus Gnathostoma. The parasite can occasionally migrate to the central nervous system, causing life-threatening disease and death. Here, we report a new point-of-care (POC) test kit, the gnathostomiasis blood immunochromatographic test (GB-ICT) kit. The kit is based on recombinant Gnathostoma spinigerum antigen and detects specific IgG4 antibody in whole-blood samples (WBSs). The GB-ICT kit showed potentially high diagnostic values with simulated WBSs (n = 248), which were obtained by spiking patients’ sera with red blood cells. The accuracy, sensitivity, specificity, and positive and negative predictive values were 95.2%, 100%, 93.8%, 81.5%, and 100%, respectively. Ten WBSs from clinically suspected gnathostomiasis patients were all positive according to the GB-ICT kit, while 10 WBSs from healthy volunteers were negative. The GB-ICT kit is a simple and convenient POC testing tool using finger-prick blood samples: venous blood sampling and serum separation processes are not required. The GB-ICT kit can support clinical diagnosis in remote areas and field settings without sophisticated equipment facilities.
