Development and evaluation of a new lateral flow immunoassay for serodiagnosis of human fasciolosis

BACKGROUND: Human fasciolosis is a re-emerging disease worldwide and is caused by species of the genus Fasciola (F. hepatica and F. gigantica). Human fasciolosis can be diagnosed by classical coprological techniques, such as the Kato-Katz test, to reveal parasite eggs in faeces. However, although 100% specific, these methods are generally not adequate for detection of acute infections, ectopic infections, or infections with low number of parasites. In such cases immunological methods may be a good alternative and are recommended for use in major hospitals where trained personnel are available, although they are not usually implemented for individual testing. METHODOLOGY/PRINCIPAL FINDINGS: We have developed a new lateral flow test (SeroFluke) for the serodiagnosis of human fasciolosis. The new test was constructed with a recombinant cathepsin L1 from F. hepatica, and uses protein A and mAb MM3 as detector reagents in the test and control lines, respectively. In comparison with an ELISA test (MM3-SERO) the SeroFluke test showed maximal specificity and sensitivity and can be used with serum or whole blood samples. CONCLUSIONS/SIGNIFICANCE: The new test can be used in major hospitals in hypoendemic countries as well as in endemic/hyperendemic regions where point-of-care testing is required.The present study was supported by grants AGL2006-13936-C02 and AGL2010-22290-C03 (Ministerio de Ciencia e Innovación, Spain), grant 2010–13 (Fundación Ramón Areces, Spain), and by the European Fund for Regional Development (FEDER). Laura Muiño is supported by grant INCITE09 PXIB 203 206 PR (Xunta de Galicia, Spain). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.S