Abstract
BackgroundVisceral leishmaniasis (VL) is a life-threatening disease caused by protozoan parasites of the Leishmania donovani complex. Early case detection followed by adequate treatment is essential to the control of VL. However, the available diagnostic tests are either invasive and require considerable expertise (parasitological demonstration of the parasite in tissue smears) or unable to distinguish between past and active infection (serological methods). Therefore, we aimed to develop a lateral flow assay in the form of an immunochromatographic test (ICT) device based on the detection of a circulating Leishmania antigen using monoclonal antibodies (mAbs).Methodology/Principal FindingsmAbs were produced by fusion of murine myeloma cells with splenocytes isolated from a mouse immunized with L. donovani soluble crude antigen. Out of 12 cloned hybridoma cell lines, two secreted mAbs recognizing the same leishmanial protein. These mAbs were used to produce an ICT as a sandwich assay for the detection of circulating antigen in serum and blood samples. The ICT was evaluated with 213 serum samples from VL patients living in VL endemic areas in China, and with 156 serum samples from patients with other diseases as well as 78 serum samples from healthy donors. Sensitivity, specificity and diagnostic efficiency of the new ICT was 95.8%, 98.7% and 97.3%, respectively. Compared with a commercially available antibody detecting ICT, our antigen-based ICT performed slightly better.Conclusion/SignificanceThe newly developed ICT is an easy to use and more accurate diagnostic tool which fulfils the performance and operational characteristics required for VL case detection under field and laboratory conditions. As our ICT detects a circulating antigen, it will also be useful in monitoring treatment success and diagnosing VL in immunocompromised patients.
Highlights
Visceral leishmaniasis (VL), or kala-azar, is a vector-borne disease caused by protozoan parasites belonging to the Leishmania donovani complex, which includes L. donovani, L. infantum and L. chagasi
Visceral leishmaniasis is a neglected disease caused by different species of protozoan parasites of the genus Leishmania
As visceral leishmaniasis is fatal if left untreated, early diagnosis is essential for treatment and control of the disease
Summary
Visceral leishmaniasis (VL), or kala-azar, is a vector-borne disease caused by protozoan parasites belonging to the Leishmania donovani complex, which includes L. donovani, L. infantum and L. chagasi. The causative agents of VL in China are L. donovani and L. infantum [4]. Visceral leishmaniasis (VL) is a life-threatening disease caused by protozoan parasites of the Leishmania donovani complex. Case detection followed by adequate treatment is essential to the control of VL. The available diagnostic tests are either invasive and require considerable expertise (parasitological demonstration of the parasite in tissue smears) or unable to distinguish between past and active infection (serological methods). We aimed to develop a lateral flow assay in the form of an immunochromatographic test (ICT) device based on the detection of a circulating Leishmania antigen using monoclonal antibodies (mAbs)
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