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Comparison of parasitological, serological, and molecular tests for visceral leishmaniasis in HIV-infected patients: a cross-sectional delayed-type study.

ABSTRACT: The aim of this study was to evaluate the accuracy of invasive and non-invasive tests for diagnosis of visceral leishmaniasis (VL) in a large series of human immunodeficiency virus (HIV)-infected patients. In this delayed-type cross-sectional study, 113 HIV-infected symptomatic patients were evaluated by an adjudication committee after clinical follow-up to establish the presence or absence of VL as the target condition (reference test). The index tests were recombinant K39 antigen-based immunochromatographic test (rK39), indirect fluorescent antibody test (IFAT), prototype kit of direct agglutination test (DAT-LPC), and real-time polymerase chain reaction (qPCR) in peripheral blood. Compared with parasitological test and adjudication committee diagnosis or latent class model analyses, IFAT and rk39 dipstick test presented the lowest sensitivity. DAT-LPC exhibited good overall performance, and there was no statistical difference between DAT-LPC and qPCR diagnosis accuracy. Real-time PCR emerges as a less invasive alternative to parasitological examination for confirmation of cases not identified by DAT.

SUBMITTER: Cota GF

PROVIDER: S-EPMC3771302 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Comparison of parasitological, serological, and molecular tests for visceral leishmaniasis in HIV-infected patients: a cross-sectional delayed-type study.

Cota Gláucia Fernandes GF de Sousa Marcos Roberto MR de Freitas Nogueira Betânia Mara BM Gomes Luciana Inácia LI Oliveira Edward E Assis Tália Santana Machado TS de Mendonça Andréa Laender Pessoa AL Pinto Bruna Fernandes BF Saliba Juliana Wilke JW Rabello Ana A

The American journal of tropical medicine and hygiene 20130708 3

The aim of this study was to evaluate the accuracy of invasive and non-invasive tests for diagnosis of visceral leishmaniasis (VL) in a large series of human immunodeficiency virus (HIV)-infected patients. In this delayed-type cross-sectional study, 113 HIV-infected symptomatic patients were evaluated by an adjudication committee after clinical follow-up to establish the presence or absence of VL as the target condition (reference test). The index tests were recombinant K39 antigen-based immunoc ...[more]

PMID: 23836568

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Project description:Human visceral leishmaniasis (VL) is a severe and potentially fatal parasitic disease if not correctly diagnosed and treated. Brazil is one of the three countries most endemic for VL and, like most countries affected by this disease, has a large budget constraint for the incorporation of new health technologies. Although different diagnostic tests for VL are currently available in the country, economic studies evaluating diagnostic kits are scarce. The objective of this study was to conduct a cost-effectiveness analysis of the nine available diagnostic tests for human VL in HIV-infected and uninfected patients in Brazil. The perspective of analysis was the Brazilian public health system, and the outcome of interest was "cases diagnosed correctly". The costs of the tests were estimated using the microcosting technique, and comparisons were performed with decision trees. Sensitivity analyses were explored applying variations in cost and effectiveness values. For VL diagnosis among HIV-uninfected patients, using blood samples for the rapid tests (RDTs), the noncommercial direct agglutination test (DAT-LPC) and IT-LEISH were cost-effective tests compared with the baseline OnSite test, but they presented different incremental cost-effectiveness ratios (ICER) of US$7.04 and US$ 205.40, respectively. Among HIV-infected patients, DAT-LPC was the most cost-effective diagnostic test. Comparisons among the tests with the same methodology, based on the low ICER values, revealed that IT-LEISH was the most cost-effective test among the RDTs and the Ridascreen Leishmania Ab among the ELISA tests. These results confirm that cost-effectiveness analyses can provide useful information to support the incorporation of new health technologies within a known scenario and willingness to pay threshold. It was observed that tests based on the same methodologies presented different cost-effectiveness ratios for the same group of patients and that different tests should be recommended for different patient groups. DAT-LPC was an important cost-effective strategy for all patients, requiring minimum laboratorial infrastructure, and IT-LEISH was the cost-effective test for VL screening in HIV-uninfected patients. IT-LEISH and DAT-LPC have complementary profiles and should both be provided by the Brazilian health system.

Project description:BACKGROUND:In Ethiopia, visceral leishmaniasis (VL) is caused by Leishmania donovani. The estimated country-wide incidence of VL in Ethiopia is 3700-7400 cases/year. The balance between anthroponotic and zoonotic transmission is still unknown even though most authors believe that visceral leishmaniasis in East Africa is anthroponotic. Asymptomatic leishmania infections occur more frequently than clinically apparent visceral leishmaniasis cases. The aim of this study was to determine the prevalence of asymptomatic VL infection and assess the degree of exposure among residents in Raya Azebo Woreda villages where cases of VL were recently reported. METHODS:A community based cross-sectional survey was conducted in 2013 between 1st of May and 25th of July. A total of 1099 individuals living in 314 households were included in the study. Socio-demographic and clinical data were collected from each of the participants and venous blood was also collected for the detection of antibodies to visceral leishmaniasis using Direct Agglutination Test. Leishmanin skin test was performed to detect the exposure to the parasite. Data was entered into excel and exported to SPSS version 17 for statistical analysis. Chi-square and the corresponding p-values were used to determine the statistical significance of the proportions/ratios obtained from the cross tabulated data. A p-value < 0.05 was considered statistically significant. RESULT:A total of 1099 study subjects comprising 401 males and 698 females were included in the study. The overall positive leishmanian skin test and sero-prevalence rates respectively were 9.08% and 0.87%. The difference in LST positivity by age group and sero-prevalence by sex were statistically significant (P <0.01 and P<0.05 respectively). Out of the 9 sero-positive individuals, 7 had no history of travel to visceral leishmaniasis endemic areas out of Raya Azebo. CONCLUSION:In general our results suggest occurrence of VL in the study area is, very low. Our survey also indicates that due to the low incidence of the disease, and lack of awareness, some patients remain under diagnosed.

Project description:We conducted a systematic literature review with indirect comparison of studies evaluating therapeutic efficacy and toxicity associated to visceral leishmaniasis (VL) therapy among HIV infected individuals.The outcomes of interest were clinical and parasitological cure, mortality, and adverse events.PRISMA guidelines for systematic reviews and Cochrane manual were followed. Sources were MEDLINE, LILACS, EMBASE, Web of Knowledge databases and manual search of references from evaluated studies. We included all studies reporting outcomes after VL treatment, regardless of their design. Study quality was evaluated systematically by using the Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in meta-analyses. Comprehensive Meta-Analysis software v.2.2.048 was used to perform one-group meta-analysis of study arms with the same drug to estimate global rates of success and adverse events with each drug. These estimates were used, when possible, to indirectly compare treatment options, adjusted for CD4 count. Direct comparison was pooled when available.Seventeen studies reporting five treatment regimens and outcome of 920 VL episodes occurring in HIV infected individuals were included. The main outstanding difference in outcome among the treatment regimens was observed in mortality rate: it was around 3 times higher with high-dose antimony use (18.4%, CI 95% 13.3-25%), indirectly compared to lipid formulations of amphotericin B treatment (6.1%, CI 95% 3.9-9.4%). It was observed, also by indirect comparison, higher rates of clinical improvement in study arms using amphotericin B than in study arms using pentavalent antimonial therapy (Sb(v)). The parasitological cure, an outcome that presented some degree of risk of selection and verification bias, had rates that varied widely within the same treatment arm, with high heterogeneity, hampering any formal comparison among drugs. One direct comparison of amphotericin and antimoniate was possible combining results of two studies and confirming the superiority of amphotericin.Available evidence suggests that amphotericin is superior to antimony treatment. Death rate using antimoniate high dose is unacceptably high. Randomized controlled trials are necessary to compare different formulations and doses of amphotericin, alternative therapies and drug combinations.

Dataset Information

Comparison of parasitological, serological, and molecular tests for visceral leishmaniasis in HIV-infected patients: a cross-sectional delayed-type study.

Publications

Comparison of parasitological, serological, and molecular tests for visceral leishmaniasis in HIV-infected patients: a cross-sectional delayed-type study.

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