Effectiveness of Fasciola gigantica excretory-secretory and recombinant cathepsin L antigens for rapid diagnosis of human fascioliasis using immunochromatographic devices.

Fascioliasis, a food- and water-borne trematodiasis, has been identified as a public health threat by the World Health Organization, with millions of people estimated to be infected or at risk of infection worldwide. We developed an immunochromatographic test (ICT) as a point-of-care (POC) tool for the rapid serodiagnosis of human fascioliasis caused by Fasciola gigantica and evaluated their diagnostic ability. Two tests were developed using antigens from adult F. gigantica excretory-secretory (ES) product and recombinant F. gigantica cathepsin L (rFgCL). Sera from 12 patients with parasitologically proven fascioliasis caused by F. gigantica, 18 with clinically suspected fascioliasis, 65 with other parasitic infections, and 30 healthy controls were used. Using a cutoff of > 0.5 for antibody detection, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the ES-based ICT method were 100%, 98.9% 96.8%, 100%, and 99.2%, respectively, and those of the rFgCL-based ICT method were 86.7%, 93.7%, 81.3%, 95.7%, and 92.0%, respectively. The concordance between the two methods was 91.2%. Tests using F. gigantica ES and rFgCL antigens can be employed quickly and easily as POC diagnostic tools. They can be used to support the clinical diagnosis of human fascioliasis gigantica and in large-scale surveys in endemic areas throughout tropical regions without necessitating additional facilities or ancillary supplies.