Accuracy of diagnostic tests for American tegumentary leishmaniasis: a systematic literature review with meta‐analyses

Abstract

objectives To analyse the accuracy of American tegumentary leishmaniasis (ATL) diagnostic methods and evaluate the quality of the existing publications by means of a systematic review. methods Diagnostic tests evaluated in at least two studies with common reference standards were included in the sensitivity and/or specificity meta-analyses. Quality and susceptibility to bias were analysed using the QUADAS-2 and STARD tools. results The title and abstract of 3387 publications were evaluated after deduplication resulting from database searches. Thirty-eight studies were included in the review, and 26 of them had results inserted in meta-analyses. The diagnostic methods with the highest pooled sensitivity values were ELISA, polymerase chain reaction (PCR), indirect immunofluorescence reaction and Montenegro's intradermal reaction. Cytometry was assessed in only two studies and presented 100% sensitivity in both. Smear slide microscopy and histopathology showed low pooled values of sensitivity. For specificity, the highest pooled values were identified for PCR. High values were also identified for ELISA, except for studies in which the reference standard for defining negative participants included individuals with Chagas' disease or paracoccidioidomycosis, which also occurred for cytometry. IFR had lower specificities than ELISA. There was a predominance of case-control designs of phase 1 or 2 and only four studies were strongly recommended as evidence generators. Several reference standards were adopted, and different methods were assessed in a small number of studies. conclusion PCR showed the highest accuracy for the diagnosis of ATL, and its use should be encouraged in clinical practice. ELISA is recommended for the screening of suspected individuals, but the possibility of cross-reactions should be considered. New validation studies for the tests evaluated in few publications and studies of phase 3 with appropriate methods are needed.

Prospective, historically controlled study to evaluate the efficacy and safety of a new paediatric formulation of nifurtimox in children aged 0 to 17 years with Chagas disease one year after treatment (CHICO)

“…Chagas disease, which is caused by infection with the protozoan parasite Trypanosoma cruzi, poses a substantial and evolving global burden in terms of morbidity, mortality and costs [1]. The World Health Organization (WHO) estimates that over 10,000 people die from the manifestations of Chagas disease annually and about 8 million individuals are infected worldwide, mostly in Latin America [2]. The burden of morbidity associated with Chagas disease is greater than that of any other parasitic disease, with mortality among infected infants of 5-20% [3].…”

“…Trypanosoma cruzi infection is curable if treatment is initiated soon after infection, and antiparasitic treatment is likely to prevent or curb disease progression in the chronic phase [9]. Accordingly, current guidelines recommend treatment with trypanocidal drugs in all patients with acute phase disease or congenital infection, those with immunosuppression or at risk of reactivated infection, and many patients with chronic infection, such as those in the indeterminate phase of the disease or with minimal cardiac involvement, and women of childbearing age (to avoid transplacental transmission) [2,10,11]. Notably, treatment with trypanocidal drugs is recommended by the Pan American Health Organization for all children younger than 18 years in the Americas, including newborns of infected mothers who have positive parasitology for T. cruzi, and women of childbearing age to prevent transplacental transmission [12].…”

Diagnostic performance of a Recombinant Polymerase Amplification Test—Lateral Flow (RPA-LF) for cutaneous leishmaniasis in an endemic setting of Colombia

“…Regarding the comparison of RPA-LF with non-gold standard diagnostic tests that are used at the point-of-care to diagnose CL, we found a high (>85%) positive and negative agreement between them (smear, histopathology and culture in a research center). RPA-LF was capable of diagnosing CL in resource-limited settings, reaching or surpassing the individual and combined sensitivity of microscopy, culture and histopathology (�80%), which are the most widely used diagnostic methods [9,[18][19][20][40][41][42]. Additionally, the sensitivity of RPA-LF was higher than the sensitivity of lesion smears which is generally reported to be <60% [8,18,[43][44][45].…”

Potential antigenic targets used in immunological tests for diagnosis of tegumentary leishmaniasis: A systematic review

“…In this sense, we consider immunnodiagosis as potential tools to increase the access and improve TL-diagnosis. Although systematic reviews have been conducted on some aspects of this form of diagnosis, it is essential to identify potential antigenic targets that have been evaluated as TL-immunodiagnostic, point out knowledge gaps that still remain and encourage other studies to allow its application in clinical practice [ 37 , 38 ]. In this way, we performed a worldwide systematic review to identify potential antigenic targets, with reported sensitivity and specificity, used as TL-immunodiagnostic.…”