Evaluation of anti-gal enzyme-linked immunosorbent assay for the diagnosis of Indian post-kala-azar dermal leishmaniasis

Background: Elimination of kala azar from India is challenging as there are potential reservoirs of Leishmania donovani in patients with post-kala-azar dermal leishmaniasis (PKDL). The vast repertoire of carbohydrate moieties on L. donovani is known to elicit specific and strong humoral responses in patients with kala azar. Aim: The present study was undertaken to evaluate the diagnostic performances of anti-gal antibodies using enzyme-linked immunosorbent assay for successful serological diagnosis of PKDL in Indian patients and to differentiate cases of past cured visceral leishmaniasis infections. Methods: We developed Gal enzyme-linked immunosorbent assay to measure specific anti-gal IgG isotype in the sera of 71 Indian patients with PKDL. The diagnostic efficacy of the newly developed assay was evaluated for precision, sensitivity and accuracy. Results: Gal2 enzyme-linked immunosorbent assay revealed three-fold increased anti-gal titers in 71 patients with active PKDL compared to controls. Subclass enzyme-linked immunosorbent assay analysis further revealed enhanced IgG2 and IgG3 anti-gal titers in patients with PKDL compared to control subjects. The rank order for specificity and sensitivity for IgG subclasses was IgG3>IgG2>IgG4>IgG1. The area under the curve values of 0.98 and 0.99 were obtained for IgG and IgG3 Gal2 enzyme-linked immunosorbent assays respectively. Overall sensitivity and specificity were 95.7% (95% CI: 88.1–99.1) and 98.1% (95% confidence interval: 90.1–99.9), and 98.5% (95% CI: 92.4–99.9) and 98.1% (95% CI: 90.1–99.9), respectively. Intra-assay coefficient of variation was 1.5% and inter-assay coefficient of variation was 11.7%. Limitations: The Gal2 enzyme-linked immunosorbent assay needs to be further investigated in mass surveys. Conclusion: Taken together, anti-gal titers detected through Gal2 enzyme-linked immunosorbent assay can serve as an effective diagnostic tool in disease elimination setting and help in better case management in endemic districts.

In vitro and in vivo adhesion properties evaluation carbomer six kinds bioadhesive material / 中国药学杂志

OBJECTIVE: To comprehensively evaluate bioadhesive properties these materials by testing adhesion properties in vitro and in vivo. METHODS: Mucin from porcine stomach model, homemade adhesion measuring device and intestinal propulsion were used for in vitro and in vivo evaluation adhesive materials. RESULTS: Carbomer 934P and HPMCK100M with high viscosity had optimal adhesion in their class, besides chitosan can be specifically bound by mucin from porcine stomach and it performed better than other materials in vivo adhesion. CONCLUSION: Above researches indicate that the bioadhesive properties had a positive correlation with viscosity in the same type material, and the relative molecular mass the materials, moisture absorption capacity, specific binding mucin and other factors should be considered in different types materials in the comprehensive evaluation.