ABSTRACT
PURPOSE: Diagnosis of leptospirosis facilitates patient management and initiation of therapy. The microscopic agglutination test (MAT) is the serological test used in reference laboratories because of its high degree of sensitivity and specificity. But the results are not available quickly for patient management. In the present study, in order to develop a simple, rapid immunodiagnostic assay, one of the outer membrane proteins (OMPs), recombinant LipL41 (rLipL41) has been utilised in latex agglutination test (LAT) and flow-through assay. METHODS: Part of LipL41 gene was expressed in Escherichia coli system and purified. The rLipL41 antigen of pathogenic Leptospira interrogans serovar Icterohaemorrhagiae, which is conserved in all pathogenic Leptospira spp. was used as capture antigen in the LAT and flow-through test. Both tests are very rapid and could be completed within 5 minutes. The sensitivity and specificity of rLipL41 was assessed and evaluated in LAT and flow-through assay in comparison with standard MAT. RESULTS: The sensitivity and specificity of the LAT were 89.70 and 90.45% and flow-through assay were 89.09 and 77.70%, respectively. CONCLUSIONS: The developed LAT and flow-through assays were simple, rapid and economical for the detection of leptospira infection and suitable for large-scale screening of samples in endemic areas without any sophisticated equipment.