Improved diagnostic sensitivity of human strongyloidiasis using point-of-care mixed recombinant antigen-based immunochromatography.

Strongyloidiasis is a neglected tropical disease that can cause fatal complications due to hyperinfection and disseminated strongyloidiasis in immunocompromised patients. We used two Strongyloides stercoralis recombinant antigenic proteins, L3NieAg.01 (NIE) and IgG-immunoreactive antigen (SsIR), to develop the recombinant antigen-based immunochromatography test (ICT) kit. We constructed and compared kits using either the NIE (NIE ICT kit) or the SsIR (SsIR ICT kit) antigens and a kit using a mixture of both (NIE-SsIR ICT kit) for detection of anti-Strongyloides IgG antibody in human serum samples. Serum samples from normal healthy individuals (Group I, n = 40), proven strongyloidiasis patients (Group II, n = 100), and those with other parasitic infections (Group III, n = 154) were evaluated. Sensitivity and specificity were 81.0% and 84.0% for the NIE ICT kit, 89.0% and 83.5% for the SsIR ICT kit, and 95.0% and 90.2% for the NIE-SsIR ICT kit, respectively. The NIE-SsIR ICT kit provided the best diagnostic results; it can supplement stool examination for clinical diagnosis and can be used to screen for asymptomatic S. stercoralis infection in people at risk in endemic areas. The NIE-SsIR ICT kit can also be used in large-scale sero-epidemiological investigations in endemic areas without the need for additional facilities or ancillary supplies.