Serological diagnosis and prognostic of tegumentary and visceral leishmaniasis using a conserved Leishmania hypothetical protein

Dias, Daniel Lucas Santos; Ribeiro, Patrícia A.F.; Salles, Beatriz C.S.; Santos, Thaís T.O.; Ramos, Fernanda F.; Lage, Daniela P.; Costa, Lourena E.; Portela, Áquila S.B.; Carvalho, Gerusa B.; Chávez-Fumagalli, Miguel Á.; Caligiorne, Rachel Basques; Oliveira, Jamil S.; Magalhães-Soares, Danielle F. de; Silva, Eduardo Sérgio da; Galdino, Alexsandro Sobreira; Menezes‐Souza, Daniel; Duarte, Mariana C.; Gonçalves, Denise Utsch; Coelho, Eduardo Antônio Ferraz

doi:10.1016/j.parint.2018.02.001

Cited by 23 publications

(9 citation statements)

References 40 publications

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“…Our research resulted in 315 manuscripts related to the serology of leishmaniasis by the combined application of descriptors in the databases described above. Only 14 studies remained ( Table 1 ) 20 , 22 , 24 , 25 , 27 , 32 - 40 after applying the eligibility criteria (duplicate texts, articles related to other topics, texts excluded due to review or quality method criteria). The studies evaluated the diagnostic accuracy of different specific and novel antigens.…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of Enzyme-Linked Immunosorbent Assays to detect anti-Leishmania antibodies in patients with American Tegumentary Leishmaniasis: a systematic review

Zanetti

Sato

Longhi³

et al. 2019

Rev. Inst. Med. trop. S. Paulo

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American Tegumentary leishmaniasis (ATL) is an infectious disease caused by several species of Leishmania . Even though the direct detection of parasites has low sensitivity, it is still the gold standard for the laboratory diagnosis of ATL. Recent studies have shown promising results of Enzyme-Linked Immunosorbent Assays ( ELISAs) using recombinant antigens. The aim of this study is to compare the accuracy of ELISAs using novel antigens with the standard ELISA based on soluble antigens of Leishmania (SLA) to diagnose ATL. Studies that analyzed patients with ATL and studies that evaluated the diagnostic accuracy of ELISAs using novel antigens and SLA were included. The Fourteen studies from PubMed, Regional Portal of the Virtual Health Library (BVS), Brazilian Society of Dermatology, Virtual Health Library (IBECS), Literature in the Health Sciences in Latin America and the Caribbean (LILACS), Medical Literature Analysis and Retrieval System Online (Medline), Elsevier Embase, Cochrane Library, The National Institute for Health and Care Excellence (NICE), and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were included. The novel ELISA antigens showed a high sensitivity (93.8%-100%) and specificity (82.5-100%), a better diagnostic performance than SLA-based ELISAs (1-97.4% and 57.5-100%, respectively). Only 10 studies analyzed cross-reactions in serum samples from patients with Chagas disease, and only two studies reported a percentage of cross-reactivity. In this systematic review, the novel ELISA antigens showed better sensitivity and specificity with respect to SLA-based ELISAs. However, a meta-analysis should be performed to confirm this finding.

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Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of Enzyme-Linked Immunosorbent Assays to detect anti-Leishmania antibodies in patients with American Tegumentary Leishmaniasis: a systematic review

Zanetti

Sato

Longhi³

et al. 2019

Rev. Inst. Med. trop. S. Paulo

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“…The sensitivity and specificity of ELISA performed with L. infantum CSA range from 40 to 96.7% and from 63 to 100%, respectively (Duarte et al, 2017;Magalhães et al, 2017;Carvalho et al, 2018;Dias et al, 2018a;Portela et al, 2018). CSAs isolated from other Leishmania species (i.e., L. major or L. braziliensis) generally display lower performance (sensitivity between 1 and 87.5%; specificity from 21.3 to 100%) (Celeste et al, 2014;Menezes-Souza et al, 2015;Dias et al, 2018b;Ribeiro et al, 2018). This sensitivity variation could result from antigenic differences among endemic isolates and cultured parasites, while specificity may depend on cross-reactivity with other endemic pathogens.…”

Section: Enzyme-linked Immunosorbent Assaymentioning

confidence: 99%

Place of Serology in the Diagnosis of Zoonotic Leishmaniases With a Focus on Visceral Leishmaniasis Due to Leishmania infantum

Lévêque

Lachaud

Simon

et al. 2020

Front. Cell. Infect. Microbiol.

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Leishmaniases are a group of parasitic diseases transmitted through the bite of female phlebotomine sandflies. Depending on the Leishmania species, the reservoirs can be humans (anthroponosis) or different animals (zoonosis). Zoonotic leishmaniasis present several clinical forms in function of the species involved: visceral leishmaniasis (VL), cutaneous leishmaniasis (CL), and muco-cutaneous leishmaniasis (MCL). The biological diagnosis is of utmost importance because the clinical features are not specific. In addition to parasitological and molecular biology (polymerase chain reaction, PCR) assays, serology is routinely used for the diagnosis of leishmaniasis. Indeed, although PCR is more sensitive than serological assays, its implementation is limited to referral laboratories and research centers. Therefore, serology is still a key element for their diagnosis. Here, we discuss the different serological assays available for the diagnosis of zoonotic leishmaniasis. We will review the enzyme-linked immunosorbent assay, immunofluorescence antibody test, immunochromatography test (ICT), direct agglutination test, and western blot as well as the different diagnostic strategies in function of the clinical form (VL, CL, and MCL). We will also discuss the place of serology for detecting asymptomatic carriers and for the follow-up of VL. Depending on the laboratory, different assays can be used, from ICT, which is appropriate for field testing, to a combination of serological tests to improve the sensitivity.

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“…In fact, mathematical modelling indicates that the key to the potential success of CVL control may be the identification of asymptomatic dogs. (19,20) In that sense, new diagnostic tests are under development with promising results in their initial stages, (21,22,23,24) but however, it is necessary to challenge these against a robust reference standard. The current context is characterised by a lack of consensus about the best reference standard for the validation of diagnostic tests for CVL, and few studies have used reasonably adequate reference standards.…”

mentioning

confidence: 99%

Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests

Teixeira

Silva

Vital

et al. 2019

Mem. Inst. Oswaldo Cruz

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BACKGROUND Studies aimed at validating canine visceral leishmaniasis diagnostic tests present heterogeneous results regarding test accuracy, partly due to divergences in reference standards used and different infection evolution periods in animals. OBJECTIVE This study aimed to evaluate the accuracy of the rapid test-dual path platform (TR-DPP) (Biomanguinhos®), EIE-Leishmaniose-Visceral-Canina-Biomanguinhos (EIE-LVC) (Biomanguinhos®), enzyme-linked immunosorbent assay (ELISA) rK39 (in-house), and the direct agglutination test (DAT- Canis ) against a reference standard comprising parasitological and molecular techniques. METHODS A phase II/III validation study was carried out in sample sera from 123 predominantly asymptomatic dogs living in an area endemic for visceral leishmaniasis. FINDINGS Sixty-nine (56.1%) animals were considered infected according to the reference standard. For each test, the sensitivity and specificity, respectively, were as follows: TR-DPP, 21.74% [confidence interval (CI)95% 13.64% to 32.82%] and 92.59% (CI95% 82.45% to 97.08%); EIE-LVC, 11.59% (CI95% 5.9% to 21.25%) and 90.74% (CI95% 80.09% to 95.98%); ELISA rK39, 37.68% (CI95% 27.18% to 49.48%) and 83.33% (CI95% 71.26% to 90.98%); and DAT- Canis , 18.84% (CI95% 11.35% to 29.61%) and 96.30% (CI95% 87.46% to 98.98%). CONCLUSION We concluded that improving the sensitivity of serum testing for diagnosing asymptomatic dogs must constitute a priority in the process of developing new diagnostic tests to be used in the visceral leishmaniasis control program in Brazil.

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Serological diagnosis and prognostic of tegumentary and visceral leishmaniasis using a conserved Leishmania hypothetical protein

Cited by 23 publications

References 40 publications

Diagnostic accuracy of Enzyme-Linked Immunosorbent Assays to detect anti-Leishmania antibodies in patients with American Tegumentary Leishmaniasis: a systematic review

Diagnostic accuracy of Enzyme-Linked Immunosorbent Assays to detect anti-Leishmania antibodies in patients with American Tegumentary Leishmaniasis: a systematic review

Place of Serology in the Diagnosis of Zoonotic Leishmaniases With a Focus on Visceral Leishmaniasis Due to Leishmania infantum

Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests

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