Global Landscape of Molecular and Immunological Diagnostic Tests for Human Leishmaniasis: A Systematic Review and Meta-Analysis.

BACKGROUND: Leishmaniasis is a serious global public health challenge. Its accurate diagnosis is essential for guiding treatment but remains complex, often requiring a combination of tests. METHODS: We conducted a systematic review and meta-analysis to evaluate the applicability and diagnostic accuracy of molecular and immunological tests for human tegumentary (TL) and visceral leishmaniasis (VL), searching PubMed for studies published between 1990-2021. RESULTS: Among 165 included studies, PCR-based tests showed high accuracy, with area under the curve values (AUCFPR) of 0.919 for TL and 0.965 for VL. For TL, serological tests exhibited median sensitivities of 83.3-88.1% and specificities of 82.0-92.4%. For VL, the direct agglutination test (DAT) and ELISA demonstrated higher sensitivity (93.0-93.8%) than rapid tests (89.1%) or immunofluorescence (82.0%), all with high specificity (95.5-96.9%). DAT performance (AUCFPR = 0.966) was comparable to molecular tests. CONCLUSIONS: Molecular tests are highly accurate for diagnosing leishmaniasis. However, their routine implementation in endemic areas is limited by the need for specialized expertise and infrastructure. We advocate for developing diagnostic procedures tailored to each endemic setting, where molecular methods could facilitate early and accurate diagnosis.