Development of Immunochromatographic Test Kit for Rapid Detection of Specific IgG4 Antibody in Whole-Blood Samples for Diagnosis of Human Gnathostomiasis

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.

[1]  Guo-Hua Liu,et al.  Human gnathostomiasis: a neglected food-borne zoonosis , 2020, Parasites & Vectors.

[2]  H. Yamasaki,et al.  Effectiveness of Fasciola gigantica excretory-secretory and recombinant cathepsin L antigens for rapid diagnosis of human fascioliasis using immunochromatographic devices , 2020, Parasitology Research.

[3]  Khayriyyah Mohd Hanafiah,et al.  Serodiagnosis and early detection of Strongyloides stercoralis infection. , 2019, Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi.

[4]  D. Erickson,et al.  High-yield paper-based quantitative blood separation system. , 2018, Lab on a chip.

[5]  Y. Nawa,et al.  Gnathostoma , 2018, Definitions.

[6]  S. Tauber,et al.  Case Report: Ocular Gnathostomiasis in Venezuela Most Likely Acquired in Texas. , 2018, The American journal of tropical medicine and hygiene.

[7]  D. Agranoff,et al.  Imported gnathostomiasis manifesting as cutaneous larva migrans and Löffler’s syndrome , 2018, BMJ Case Reports.

[8]  M. Pal,et al.  Public Health Significance of Foodborne Helminthiasis: A Systematic Review , 2018 .

[9]  A. Hoerauf,et al.  Pathological manifestations in lymphatic filariasis correlate with lack of inhibitory properties of IgG4 antibodies on IgE-activated granulocytes , 2017, PLoS neglected tropical diseases.

[10]  K. M. Koczula,et al.  Lateral flow assays , 2016, Essays in biochemistry.

[11]  H. Yamasaki,et al.  Development and usefulness of an immunochromatographic device to detect antibodies for rapid diagnosis of human gnathostomiasis , 2016, Parasites & Vectors.

[12]  P. Dekumyoy,et al.  First case of neurognathostomiasis in Taiwan--A Thai laborer presenting with eosinophilic meningitis and intracranial hemorrhage. , 2015, Journal of the Formosan Medical Association = Taiwan yi zhi.

[13]  J. Diaz.  Gnathostomiasis: An Emerging Infection of Raw Fish Consumers in Gnathostoma Nematode-Endemic and Nonendemic Countries. , 2015, Journal of travel medicine.

[14]  C. Tayapiwatana,et al.  A dot-ELISA test using a Gnathostoma spinigerum recombinant matrix metalloproteinase protein for the serodiagnosis of human gnathostomiasis. , 2014, The Southeast Asian journal of tropical medicine and public health.

[15]  A. Cheepsattayakorn,et al.  Parasitic Pneumonia and Lung Involvement , 2014, BioMed research international.

[16]  C. Wongkham,et al.  A Recombinant Matrix Metalloproteinase Protein from Gnathostoma spinigerum for Serodiagnosis of Neurognathostomiasis , 2013, The Korean journal of parasitology.

[17]  T. Nutman,et al.  Extended Result Reading Window in Lateral Flow Tests Detecting Exposure to Onchocerca volvulus: A New Technology to Improve Epidemiological Surveillance Tools , 2013, PloS one.

[18]  C. Wongkham,et al.  Application of recombinant Gnathostoma spinigerum matrix metalloproteinase-like protein for serodiagnosis of human gnathostomiasis by immunoblotting. , 2013, The American journal of tropical medicine and hygiene.

[19]  Brendan O’Farrell,et al.  Lateral Flow Immunoassay Systems: Evolution from the Current State of the Art to the Next Generation of Highly Sensitive, Quantitative Rapid Assays , 2013 .

[20]  J. Finsterer,et al.  Parasitoses of the human central nervous system , 2012, Journal of Helminthology.

[21]  K. Sawanyawisuth,et al.  Immunoblot diagnostic test for neurognathostomiasis. , 2010, The American journal of tropical medicine and hygiene.

[22]  A. Hoerauf,et al.  Induction of immunoglobulin G4 in human filariasis: an indicator of immunoregulation , 2010, Annals of tropical medicine and parasitology.

[23]  P. Chiodini,et al.  Gnathostomiasis, Another Emerging Imported Disease , 2009, Clinical Microbiology Reviews.

[24]  V. Chotmongkol,et al.  Evaluation of IgG4 and total IgG antibodies against cysticerci and peptide antigens for the diagnosis of human neurocysticercosis by ELISA. , 2008, Asian Pacific journal of allergy and immunology.

[25]  J. Costa-Cruz,et al.  IgG1, IgG4, and IgE antibody responses in human strongyloidiasis by ELISA using Strongyloides ratti saline extract as heterologous antigen , 2007, Parasitology Research.

[26]  C. Wongkham,et al.  Evaluation of human IgG class and subclass antibodies to a 24 kDa antigenic component of Gnathostoma spinigerum for the serodiagnosis of gnathostomiasis , 2007, Parasitology Research.

[27]  P. Dekumyoy,et al.  Diagnostic values of IgG4 in human gnathostomiasis , 2005, Tropical medicine & international health : TM & IH.

[28]  H. Nariuchi,et al.  A Quantitative Immunochromatography Assay of Whole Blood Samples for Antigen-specific IgE—A New Method for Point of Care Testing for Allergens— , 2005 .

[29]  T. Garate,et al.  Cutaneous and medullar gnathostomiasis in travelers to Mexico and Thailand. , 2006, Journal of travel medicine.

[30]  P. Chiodini,et al.  Gnathostomiasis: An Emerging Imported Disease , 2003, Emerging Infectious Diseases.

[31]  C. Wongkham,et al.  Immunoblot evaluation of the specificity of the 29-kDa antigen from young adult female worms Angiostrongylus cantonensis for immunodiagnosis of human angiostrongyliasis. , 2001, Asian Pacific journal of allergy and immunology.

[32]  S. Nuchprayoon,et al.  Specific IgE antibody responses to somatic and excretory-secretory antigens of third stage G. spinigerum larvae in human gnathostomiasis. , 2001, Journal of the Medical Association of Thailand = Chotmaihet thangphaet.

[33]  Y. Kitaura,et al.  Development of a simple whole blood panel test for detection of human heart-type fatty acid-binding protein. , 2001, Clinical biochemistry.

[34]  S. Tuntipopipat,et al.  A simplified method for the fractionation of Gnathostoma-specific antigens for serodiagnosis of human gnathostomosis , 1993, Journal of Helminthology.

[35]  B. Sandhagen,et al.  Improving lactate analysis with the YSI 2300 GL: hemolyzing blood samples makes results comparable with those for deproteinized whole blood. , 1992, Clinical chemistry.

[36]  P. Tapchaisri,et al.  Purification of Gnathostoma spinigerum specific antigen and immunodiagnosis of human gnathostomiasis. , 1991, International journal for parasitology.

[37]  C. Khamboonruang,et al.  The value of enzyme-linked immunosorbent assay (ELISA) for diagnosis of human trichinosis. , 1991, Tropical medicine and parasitology : official organ of Deutsche Tropenmedizinische Gesellschaft and of Deutsche Gesellschaft fur Technische Zusammenarbeit.

[38]  P. Tapchaisri,et al.  Specific antigen of Gnathostoma spinigerum for immunodiagnosis of human gnathostomiasis. , 1991, International journal for parasitology.

[39]  C. Khamboonruang,et al.  Serodiagnosis of human gnathostomiasis. , 1988, The Southeast Asian journal of tropical medicine and public health.

[40]  R. Anderson,et al.  The epidemiology and control of intestinal helminths in the Pulicat Lake region of Southern India. I. Study design and pre- and post-treatment observations on Ascaris lumbricoides infection. , 1986, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[41]  G. Cook.  The clinical significance of gastrointestinal helminths--a review. , 1986, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[42]  R. Galen,et al.  Predictive value and efficiency of laboratory testing. , 1980, Pediatric clinics of North America.

[43]  T. Chirachariyavej,et al.  Neurological manifestations of gnathostomiasis , 1977, Journal of the Neurological Sciences.