Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers

CASES:

Inclusion criteria

• 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.
• adult subjects (equal or older than 18 years)

Exclusion criteria

• lack of the necessary data and/or of biological samples
• subjects younger than 18 years

COMMUNITY CONTROLS:

Inclusion criteria

• 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
• adult subjects (equal or older than 18 years)
• being negative to two different serological tests for leishmaniasis

Exclusion criteria

• subjects younger than 18 years
• being positive to one serological tests for leishmaniasis.

VALIDATION CONTROLS (VC):

Inclusion criteria

• serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy.
• informed consent signed to Tropical Biobank
• adult subjects (equal or older than 18 years)
• being negative to two different serological tests for leishmaniasis.
• being clinically diagnosed with Chagas disease or TB, or malaria or leprosy

Exclusion criteria

• younger than 18 years
• positive result to one serological test for leishmaniasis.