Field evaluation of a fast anti-Leishmania antibody detection assay in Ethiopia

Hailu, Asrat; Schoone, Gerard J.; Diro, E.; Tesfaye, Annisa Befekadu; Techane, Y.; Tefera, Tedros; Assefa, Yibeltal; Genetu, Abebe; Kebede, Yenew; Kebede, Tedla; Schallig, Henk D. F. H.

doi:10.1016/j.trstmh.2005.07.003

Cited by 13 publications

(7 citation statements)

References 13 publications

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“…In the present study, FAST exhibited values for sensitivity and specificity (92 and 100 %, respectively) that were higher than those of the other tests and well within the range (80 to (Hailu et al 2006;Schallig et al 2002). In contrast, the observed sensitivity of DAT (87 %) was below literature values, which range from 93 to 100 %, while the specificity of the test (100 %) exceeded the previously reported values of 91 % (Silva et al 2006) and 95 % (Ferreira et al 2007;Hailu et al 2006;Veeken et al 2003).…”

Section: Discussioncontrasting

confidence: 79%

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Ability of immunodiagnostic tests to differentiate between dogs naturally infected with Leishmania infantum and Leishmune®-vaccinated dogs

et al. 2015

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Visceral leishmaniasis (VL) is a serious chronic disease with a lethality rate of up to 10% in humans. In urban areas of Brazil, dogs are the main reservoirs of the etiological agent (Leishmania infantum) of VL, and the Brazilian Ministry of Health recommends the euthanasia of animals that are seropositive in both the immunochromatographic dual path platform rapid test (DPP(®); Bio-Manguinhos) and the enzyme-linked immunosorbent assay (ELISA) with an L. major-like antigen (Bio-Manguinhos). Vaccination is an additional tool in the control of canine VL, but the use of Leishmune(®) (Zoetis Indústria de Produtos Veterinários, São Paulo, SP, Brazil), which contains the fucose mannose ligand (FML) isolated from L. donovani, is not currently recommended by the Brazilian Ministry of Health because vaccinated animals may exhibit positive serology and there are reservations regarding the efficacy of the vaccine. The aims of the present study were: (i) to verify the abilities of the fast agglutination screening test (FAST), the direct agglutination test (DAT), the indirect fluorescent-antibody test (IFAT), the DPP rapid test, and ELISA tests with L. major-like and FML antigens to differentiate between L. infantum-infected and Leishmune(®)-vaccinated dogs, and (ii) to analyze the sensitivities and specificities of the different methods. The reactivities to these tests of Leishmune(®)-vaccinated dogs (n = 71), asymptomatic (n = 20) and symptomatic (n = 20) naturally infected dogs, and unvaccinated healthy control dogs (n = 5) were compared. None of the Leishmune(®)-vaccinated dogs tested seropositive in FAST and DAT, although one dog was reactive to DPP and four dogs to ELISA/L. major-like and IFAT tests. While 69 (97%) of vaccinated dogs reacted to ELISA/FML, only one was seropositive in both ELISA/L. major-like and IFAT tests. Individually, all immunodiagnostic tests presented high specificities and positive likelihood ratios (LR+), and high specificity values were obtained when the tests were considered in pairs. However, sensitivity and LR- values were low for ELISA/L. major-like and IFAT tests individually, and for all pair combinations of tests except for FAST with DPP.

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Section: Discussioncontrasting

confidence: 79%

“…In contrast, the observed sensitivity of DAT (87 %) was below literature values, which range from 93 to 100 %, while the specificity of the test (100 %) exceeded the previously reported values of 91 % (Silva et al 2006) and 95 % (Ferreira et al 2007;Hailu et al 2006;Veeken et al 2003). The sensitivity of the ELISA/L.…”

Section: Discussioncontrasting

confidence: 60%

Ability of immunodiagnostic tests to differentiate between dogs naturally infected with Leishmania infantum and Leishmune®-vaccinated dogs

et al. 2015

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“…Two studies assessed the accuracy of the Fast agglutination screening test (FAST), one in Ethiopia (Hailu 2006) and one in Turkey (Kilic 2008). Both studies were small (89 participants in Ethiopia and 59 in Turkey).…”

Section: Resultsmentioning

confidence: 99%

Rapid tests for the diagnosis of visceral leishmaniasis in patients with suspected disease

Boelaert

Verdonck

Menten

et al. 2014

Cochrane Database of Systematic Reviews

116

140

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Background The diagnosis of visceral leishmaniasis (VL) in patients with fever and a large spleen relies on showing Leishmania parasites in tissue samples and on serological tests. Parasitological techniques are invasive, require sophisticated laboratories, consume time, or lack accuracy. Recently, rapid diagnostic tests that are easy to perform have become available. Objectives To determine the diagnostic accuracy of rapid tests for diagnosing VL in patients with suspected disease presenting at health services in endemic areas. Search methods We searched MEDLINE, EMBASE, LILACS, CIDG SR, CENTRAL, SCI‐expanded, Medion, Arif, CCT, and the WHO trials register on 3 December 2013, without applying language or date limits. Selection criteria This review includes original, phase III, diagnostic accuracy studies of rapid tests in patients clinically suspected to have VL. As reference standards, we accepted: (1) direct smear or culture of spleen aspirate; (2) composite reference standard based on one or more of the following: parasitology, serology, or response to treatment; and (3) latent class analysis. Data collection and analysis Two review authors independently extracted data and assessed quality of included studies using the QUADAS‐2 tool. Discrepancies were resolved by a third author. We carried out a meta‐analysis to estimate sensitivity and specificity of rapid tests, using a bivariate normal model with a complementary log‐log link function. We analysed each index test separately. As possible sources of heterogeneity, we explored: geographical area, commercial brand of index test, type of reference standard, disease prevalence, study size, and risk of bias (QUADAS‐2). We also undertook a sensitivity analysis to assess the influence of imperfect reference standards. Main results Twenty‐four studies containing information about five index tests (rK39 immunochromatographic test (ICT), KAtex latex agglutination test in urine, FAST agglutination test, rK26 ICT, and rKE16 ICT) recruiting 4271 participants (2605 with VL) were included. We carried out a meta‐analysis for the rK39 ICT (including 18 studies; 3622 participants) and the latex agglutination test (six studies; 1374 participants). The results showed considerable heterogeneity. For the rK39 ICT, the overall sensitivity was 91.9% (95% confidence interval (95% CI) 84.8 to 96.5) and the specificity 92.4% (95% CI 85.6 to 96.8). The sensitivity was lower in East Africa (85.3%; 95% CI 74.5 to 93.2) than in the Indian subcontinent (97.0%; 95% CI 90.0 to 99.5). For the latex agglutination test, overall sensitivity was 63.6% (95% CI 40.9 to 85.6) and specificity 92.9% (95% CI 76.7 to 99.2). Authors' conclusions The rK39 ICT shows high sensitivity and specificity for the diagnosis of visceral leishmaniasis in patients with febrile splenome...

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“…This makes the test very suitable for the screening of large populations. The sensitivity and specificity of FAST were found to be 91.1%-95.4% and 70.5%-88.5%, respectively [80,81].…”

Section: Direct Agglutination Test (Dat)mentioning

confidence: 93%

Diagnosis of leishmaniasis

Elmahallawy

Martínez

Rodríguez‐Grangér

et al. 2014

J Infect Dev Ctries

154

119

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Leishmaniasis is a clinically heterogeneous syndrome caused by intracellular protozoan parasites of the genus Leishmania. The clinical spectrum of leishmaniasis encompasses subclinical ( not apparent), localized (skin lesion), and disseminated (cutaneous, mucocutaneous, and visceral) infection. This spectrum of manifestations depends on the immune status of the host, on the parasite, and on immunoinflammatory responses. Visceral leishmaniasis causes high morbidity and mortality in the developing world. Reliable laboratory methods become mandatory for accurate diagnosis, especially in immunocompromised patients such as those infected with HIV. In this article, we review the current state of the diagnostic tools for leishmaniasis, especially the serological test.

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Field evaluation of a fast anti-Leishmania antibody detection assay in Ethiopia

Cited by 13 publications

References 13 publications

Ability of immunodiagnostic tests to differentiate between dogs naturally infected with Leishmania infantum and Leishmune®-vaccinated dogs

Ability of immunodiagnostic tests to differentiate between dogs naturally infected with Leishmania infantum and Leishmune®-vaccinated dogs

Rapid tests for the diagnosis of visceral leishmaniasis in patients with suspected disease

Diagnosis of leishmaniasis

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