Serological and molecular tools to diagnose visceral leishmaniasis: 2-years' experience of a single center in Northern Italy

• Published in: PloS one Vol. 12; no. 8; p. e0183699
• Main Authors: Varani, Stefania, Ortalli, Margherita, Attard, Luciano, Vanino, Elisa, Gaibani, Paolo, Vocale, Caterina, Rossini, Giada, Cagarelli, Roberto, Pierro, Anna, Billi, Patrizia, Mastroianni, Antonio, Di Cesare, Simona, Codeluppi, Mauro, Franceschini, Erica, Melchionda, Fraia, Gramiccia, Marina, Scalone, Aldo, Gentilomi, Giovanna A, Landini, Maria P
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 23.08.2017; Public Library of Science (PLoS)
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Biology and Life Sciences; Bone marrow; Care and treatment; Child; Child, Preschool; Criteria; Diagnosis; Diagnostic systems; Diagnostic tests; Female; Health screening; HIV; Hospitals; Human immunodeficiency virus; Humans; Immunocompromised hosts; Infant; Infant, Newborn; Infectious diseases; Italy; Laboratories; Leishmaniasis, Visceral - blood; Leishmaniasis, Visceral - diagnosis; Male; Medical diagnosis; Medicine and Health Sciences; Methods; Microbiology; Microscopy; Middle Aged; Molecular Diagnostic Techniques; Parasitic diseases; Patients; Pediatrics; People and Places; Polymerase chain reaction; Public health; Research and Analysis Methods; Screening; Sensitivity; Sensitivity and Specificity; Serological tests; Serology; Standardization; Vector-borne diseases; Vectors (Biology); Visceral leishmaniasis; Workflow; Young Adult; Italy
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0183699

The diagnosis of visceral leishmaniasis (VL) remains challenging, due to the limited sensitivity of microscopy, the poor performance of serological methods in immunocompromised patients and the lack of standardization of molecular tests. The aim of this study was to implement a combined diagnostic workflow by integrating serological and molecular tests with standardized clinical criteria. Between July 2013 and June 2015, the proposed workflow was applied to specimens obtained from 94 in-patients with clinical suspicion of VL in the Emilia-Romagna region, Northern Italy. Serological tests and molecular techniques were employed. Twenty-one adult patients (22%) had a confirmed diagnosis of VL by clinical criteria, serology and/or real-time polymerase chain reaction; 4 of these patients were HIV-positive. Molecular tests exhibited higher sensitivity than serological tests for the diagnosis of VL. In our experience, the rK39 immunochromatographic test was insufficiently sensitive for use as a screening test for the diagnosis of VL caused by L. infantum in Italy. However, as molecular tests are yet not standardized, further studies are required to identify an optimal screening test for Mediterranean VL.