This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples.
General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.
Leishmania positive patient from Italy (n=30) and from Sudan (n=30);
patient with a clinically or laboratory confirmed diagnosis of leishmaniasis;
signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM)
being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp.
lack of the necessary data and/or of biological samples
subjects younger than 18 years
Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp.
signed informed consent to Tropica Biobank