Table 3.
Clinical sensitivity and specificity of different immunological and molecular methods for diagnosis of leishmaniases
| Method/clinical form | Specimen | Antigen/target | Sensitivity (%) | Specificity (%) | Reference (s) |
|---|---|---|---|---|---|
| Immunological tests: | |||||
| ELISA/VL | Human serum | rK39 | 96 | 100 | [19] |
| TRALd/VL | Human serum | rK39, K26 | 100 | 98 | [24] |
| FC-ALPA/CL | Human serum | Live L. braziliensis promastigotes | 85.7–97.9 | 76.0–93.7 | [29] |
| FC-ALPA-IgG/CL | Human serum | Live L. braziliensis promastigotes | 86 | 78 | [30] |
| FC-AFPA-IgG/CL | Human serum | Fixed L. braziliensis promastigotes | 90 | 78 | [30] |
| Molecular tests: | |||||
| cPCR/VL | Human blood | ITS-1, kDNA minicircle | 53.7–97.78 | 61.82–100 | [41, 51] |
| cPCR/VL | Canine blood | ITS-1, kDNA minicircle | 72.2–98.7 | 83.3–96.4 | [41, 43, 50] |
| qPCR/VL | Human blood | ITS-1, kDNA minicircle | 91.3–100 | 29.6–100 | [41, 51] |
| NASBA-OC/VL | Human blood | 18S RNA; 18S DNA | 79.8–93.3 | 100 | [66, 67] |
| LAMP/VL | Human blood | kDNA minicircle | 96.4 | 98.5 | [72] |
| LAMP/PKDL | Human tissue biopsy | kDNA minicircle | 96.8 | 98.5 | [72] |
| LAMP/VL | Canine blood | cysteine Protease B (cpb) | 38.2–69.5 | 65.2–89.5 | [73] |
ELISA Enzyme-linked immunosorbent assay, TRALd Rapid Antibody Test Leishmania donovani. FC-ALPA/AFPA flow cytometry anti-live/fixed promastigote antibody, cPCR conventional PCR, qPCR real-time quantitative PCR, NASBA-OC Nucleic Acid Sequence-Based Assay- oligochromatography, LAMP Loop-mediated isothermal amplification