Abstract
Leishmaniasis is a neglected tropical disease affecting humans and domesticated animals with high mortality in endemic countries. The pleiotropy of symptoms and the complicated gold-standard methods make the need for non-invasive, highly sensitive diagnostic tests imperative. Individual studies on molecular-based Leishmania diagnosis in urine show high discrepancy; thus, a data-evidenced comparison of various techniques is necessary. We performed a systematic review and meta-analysis using the bivariate method of diagnostic methods to pool sensitivities and specificities. We investigated the impact of DNA-extraction method, PCR type, amplified locus, host species, leishmaniasis form, and geographical region. The pooled sensitivity was 69.2%. Tests performed with the kit-based DNA extraction method and qPCR outweighed in sensitivity the phenol-chloroform-based and PCR methods, while their combination showed a sensitivity of 79.3%. Amplified locus, human or canine as host and cutaneous or visceral leishmaniasis revealed similar sensitivities. Tests in European and Middle Eastern countries performed better than tests in other regions (sensitivity 81.7% vs. 43.7%). A combination of kit-based DNA extraction and qPCR could be a safer choice for molecular diagnosis for Leishmania infection in urine samples in European–Middle Eastern countries. For the rest of the world, more studies are needed to better characterize the endemic parasite species.
Highlights
Leishmaniases are vector-borne diseases caused by at least 54 protozoan parasite species of the genus Leishmania, 21 of which are pathogenic to humans
All studies reported that infection was ascertained by at least two different methods in accordance with standard protocols developed for the different forms of leishmaniasis [10,17]
For DNA extraction from urine samples, phenol–chloroform based extraction method [20] was used in four studies, while seven kits from four different companies were reported in nine studies
Summary
Leishmaniases are vector-borne diseases caused by at least 54 protozoan parasite species of the genus Leishmania, 21 of which are pathogenic to humans. They are transmitted to the mammalian hosts by infected female sandflies [1,2]. Leishmaniasis is considered a neglected tropical disease that comprises a high disease burden in developing (and a few developed) countries. The disease is displayed with a broad range of severity and symptoms ranging from asymptomatic to life threatening VL cases, all related to the infecting parasite, vector biology, genetic and immune status of the host, as well as co-infections [2,6]. Other risk factors include poverty, malnutrition, population displacement, poor housing or even wars [5]
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