Abstract
BackgroundHuman visceral leishmaniasis (VL), a potentially fatal disease, has emerged as an important opportunistic condition in HIV infected patients. In immunocompromised patients, serological investigation is considered not an accurate diagnostic method for VL diagnosis and molecular techniques seem especially promising.ObjectiveThis work is a comprehensive systematic review and meta-analysis to evaluate the accuracy of serologic and molecular tests for VL diagnosis specifically in HIV-infected patients.MethodsTwo independent reviewers searched PubMed and LILACS databases. The quality of studies was assessed by QUADAS score. Sensitivity and specificity were pooled separately and compared with overall accuracy measures: diagnostic odds ratio (DOR) and symmetric summary receiver operating characteristic (sROC).ResultsThirty three studies recruiting 1,489 patients were included. The following tests were evaluated: Immunofluorescence Antibody Test (IFAT), Enzyme linked immunosorbent assay (ELISA), immunoblotting (Blot), direct agglutination test (DAT) and polimerase chain reaction (PCR) in whole blood and bone marrow. Most studies were carried out in Europe. Serological tests varied widely in performance, but with overall limited sensitivity. IFAT had poor sensitivity ranging from 11% to 82%. DOR (95% confidence interval) was higher for DAT 36.01 (9.95–130.29) and Blot 27.51 (9.27–81.66) than for IFAT 7.43 (3.08–1791) and ELISA 3.06 (0.71–13.10). PCR in whole blood had the highest DOR: 400.35 (58.47–2741.42). The accuracy of PCR based on Q-point was 0.95; 95%CI 0.92–0.97, which means good overall performance.ConclusionBased mainly on evidence gained by infection with Leishmania infantum chagasi, serological tests should not be used to rule out a diagnosis of VL among the HIV-infected, but a positive test at even low titers has diagnostic value when combined with the clinical case definition. Considering the available evidence, tests based on DNA detection are highly sensitive and may contribute to a diagnostic workup.
Highlights
Leishmaniasis gained higher clinical importance in individuals infected with HIV-1 as an opportunistic infection in areas where both infections are endemic
Our data allow some conclusions based on available evidence, which essentially reflect the European experience with serological and molecular diagnosis of visceral leishmaniasis (VL) among HIV-infected: (1) the available evidence is limited and there is great variability among the studies; (2) the accuracy of molecular methods is greater than the serological methods; (3) direct agglutination test (DAT) and Blot have better global accuracy among serological tests; (4) specificity was generally high for all serological tests, there is unexpectedly high variation in specificity among studies evaluating the same test; (5) serological tests vary widely in performance, but with overall limited sensitivity in HIV infected patients
Among serologic tests, based on diagnostic odds ratio (DOR), we observed that Blot and DAT are superior to Enzyme linked immunosorbent assay (ELISA) and Immunofluorescence Antibody Test (IFAT)
Summary
Leishmaniasis gained higher clinical importance in individuals infected with HIV-1 (human immunodeficiency virus type-1) as an opportunistic infection in areas where both infections are endemic. The clinical course of the disease is even less specific and can be masked by other associated opportunistic infection [1]. Co-infected patients classically present a chronic clinical course and high rate of treatment failure [2]. Demonstration of Leishmania parasites in bone marrow aspirate or in other biologic specimens, either by visualization or culture, is the most reliable diagnostic technique in the setting of HIV co-infection. Human visceral leishmaniasis (VL), a potentially fatal disease, has emerged as an important opportunistic condition in HIV infected patients. Serological investigation is considered not an accurate diagnostic method for VL diagnosis and molecular techniques seem especially promising
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