Table 1.
Summary of the main methods used for diagnosis of CL and VL.
| Diagnostic Method | Clinical Form | Culture Required | Species Discrimination 1 | Reference(s) | |
|---|---|---|---|---|---|
| Parasitological methods | Biopsy, punch, scraping, smear or imprinting followed by microscopic examination | CL | No | No (only genus Leishmania) | [25,26,29,30] |
| Bone marrow, lymph nodes or spleen aspirates or liver biopsy followed by microscopic examination | VL | No | No (only genus Leishmania) | [33,34] | |
| In vitro cultivation | VL, CL | Yes | No (only genus Leishmania) | [37] | |
| Inoculation in animals (mice or hamsters) | VL, CL | No | No (only genus Leishmania) | [22,35] | |
| Xenodiagnosis | VL | No | No (only genus Leishmania) | [39,40] | |
| Protein-based methods | MLEE | VL, CL | Yes | Yes (almost all currently identified species) | [41] |
| Monoclonal antibodies | VL, CL | Yes | Yes (almost all species endemic in the Americas and also L. (L.) major, L. (L.) donovani and L. (L.) tropica) | [42,43,44,45] | |
| MALDI-TOF MS | VL, CL | Yes | Yes (all species endemic in the Americas, Europe, Asia and Africa) | [46,47,48] | |
| KAtex | VL | No | No (only genus Leishmania) | [49,50,51] | |
| DNA-based methods | PCR-RFLP | VL, CL | No | Yes (almost all species; depends on the target) | [9,52] |
| DNA sequencing | VL, CL | No | Yes (almost all species; depends on the target) | [9,52] | |
| Real-time PCR | VL, CL | No | Yes (most species) | [53,54] | |
| PCR-HRM | VL, CL | No | Yes (almost all species endemic in the Americas, Europe, Asia and Africa) | [55,56,57,58,59] | |
| MLST | VL, CL | No | Yes (all species) | [60,61,62,63] | |
| LAMP | VL, CL | No | Yes (limited to certain species) | [64,65,66,67] | |
| Immunological-based methods | Leishmania skin test | CL (negative for DCL) | No | No (only genus Leishmania) | [16] |
| ELISA (rK39) | VL | No | No (only genus Leishmania) | [68,69,70,71,72,73] | |
| ELISA (other recombinant antigens) | VL, CL | No | No (only genus Leishmania) | [74,75,76,77,78,79,80,81,82,83,84,85] | |
| IFAT | VL, CL | No | No (only genus Leishmania) | [71,86,87,88,89] | |
| DAT | VL | No | No (only genus Leishmania) | [50,71,86,87,90,91] | |
| ICT (rK39) | VL | No | No (only genus Leishmania) | [50,70,86,90,92] | |
| Dipstick test [L. (L.) donovani promastigote antigens] | VL | No | No (only genus Leishmania) | [93,94] | |
| Western blot | VL, CL | No | No (only genus Leishmania) | [95,96,97,98] |
1 Check in the text and references for details of species evaluated in the respective methods.