BACKGROUND: @entity234 ( @entity234 ) is a life-threatening disease caused by protozoan parasites of the @entity3911 complex. Early case detection followed by adequate treatment is essential to the control of @entity234 . 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 @entity281 (serological methods). Therefore, we aimed to develop a lateral flow assay in the form of an @entity1062 ( @entity1062 ) device based on the detection of a circulating @entity3911 antigen using monoclonal antibodies (mAbs). METHODOLOGY/PRINCIPAL FINDINGS: mAbs were produced by fusion of @entity19 @entity1582 cells with splenocytes isolated from a @entity19 immunized with @entity3911 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 @entity1062 as a sandwich assay for the detection of circulating antigen in serum and blood samples. The @entity1062 was evaluated with 213 serum samples from @entity234 @entity1 living in @entity234 endemic areas in China, and with 156 serum samples from @entity1 with other diseases as well as 78 serum samples from healthy donors. Sensitivity, specificity and diagnostic efficiency of the new @entity1062 was 95.8%, 98.7% and 97.3%, respectively. Compared with a commercially available antibody detecting @entity1062 , our antigen-based @entity1062 performed slightly better. CONCLUSION/SIGNIFICANCE: The newly developed @entity1062 is an easy to use and more accurate diagnostic tool which fulfils the performance and operational characteristics required for @entity234 case detection under field and laboratory conditions. As our @entity1062 detects a circulating antigen, it will also be useful in monitoring treatment success and diagnosing @entity234 in immunocompromised @entity1 .

Development of an Immunochromatographic Test for Diagnosis of XXXX Based on Detection of a Circulating Antigen.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity19 :: ('10090', 'Species') :: ['mouse', 'murine'] @entity234 :: ('MESH:D007898', 'Disease') :: ['VL', 'Visceral leishmaniasis'] @entity1582 :: ('MESH:D009101', 'Disease') :: ['myeloma'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infection'] @entity1062 :: ('MESH:D013736', 'Disease') :: ['immunochromatographic test', 'ICT'] @entity3911 :: ('5661', 'Species') :: ['Leishmania donovani', 'L. donovani', 'Leishmania']
@entity234 :: (MESH:D007898,Disease) :: ['Visceral Leishmaniasis']
