Development of an Immunochromatographic Test for Diagnosis of Visceral Leishmaniasis Based on Detection of a Circulating Antigen

摘要: Background Visceral leishmaniasis (VL) is a life-threatening disease caused by protozoan parasites of the Leishmania donovani complex. Early case detection followed adequate treatment essential to control VL. However, available diagnostic tests are either invasive and require considerable expertise (parasitological demonstration parasite in tissue smears) or unable distinguish between past active infection (serological methods). Therefore, we aimed develop lateral flow assay form an immunochromatographic test (ICT) device based on circulating antigen using monoclonal antibodies (mAbs). Methodology/Principal Findings mAbs were produced fusion murine myeloma cells with splenocytes isolated from mouse immunized L. soluble crude antigen. Out 12 cloned hybridoma cell lines, two secreted recognizing same leishmanial protein. These used produce ICT as sandwich for serum blood samples. The was evaluated 213 samples VL patients living endemic areas China, 156 other diseases well 78 healthy donors. Sensitivity, specificity efficiency new 95.8%, 98.7% 97.3%, respectively. Compared commercially antibody detecting ICT, our antigen-based performed slightly better. Conclusion/Significance newly developed easy use more accurate tool which fulfils performance operational characteristics required under field laboratory conditions. As detects antigen, it will also be useful monitoring success diagnosing immunocompromised patients.