Dataset Information

Cost-effectiveness of serological tests for human visceral leishmaniasis in the Brazilian scenario.

ABSTRACT: 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.

SUBMITTER: Freire ML

PROVIDER: S-EPMC7544087 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Cost-effectiveness of serological tests for human visceral leishmaniasis in the Brazilian scenario.

Freire Mariana Lourenço ML de Souza Aline A Cota Gláucia G Rabello Ana A Machado de Assis Tália T

PLoS neglected tropical diseases 20201008 10

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 co ...[more]

PMID: 33031382

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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:Visceral leishmaniasis (VL) still represents a serious public health problem in Brazil due to the inefficiency of the control measures currently employed, that included early diagnosis and treatment of human cases, vector control, euthanasia of infected dogs and, recently approved in Brazil, treatment with Milteforam drug. Effective clinical management depend largely on early and unequivocal diagnosis, however, cross-reactivity have also been described in serological tests, especially when it refers to individuals from areas where Chagas' disease is also present. Thus, to discover new antigens to improve the current serological tests for VL diagnosis is urgently needed. Here, we performed an immunogenomic screen strategy to identify conserved linear B-cell epitopes in the predicted L. infantum proteome using the following criteria: i) proteins expressed in the stages found in the vertebrate host, amastigote stage, and secreted/excreted, to guarantee greater exposure to the immune system; ii) divergent from proteins present in other infectious disease pathogens with incidence in endemic areas for VL, as T. cruzi; iii) highly antigenic to humans with different genetic backgrounds, independently of the clinical stage of the disease; iv) stable and adaptable to quality-control tests to guarantee reproducibility; v) using statistical analysis to determine a suitable sample size to evaluate accuracy of diagnostic tests established by receiver operating characteristic strategy. We selected six predicted linear B-cell epitopes from three proteins of L. infantum parasite. The results demonstrated that a mixture of peptides (Mix IV: peptides 3+6) were able to identify VL cases and simultaneously able to discriminate infections caused by T. cruzi parasite with high accuracy (100.00%) and perfect agreement (Kappa index = 1.000) with direct methods performed by laboratories in Brazil. The results also demonstrated that peptide-6, Mix III (peptides 2+6) and I (peptides 2+3+6) are potential antigens able to used in VL diagnosis, represented by high accuracy (Ac = 99.52%, 99.52% and 98.56%, respectively). This study represents an interesting strategy for discovery new antigens applied to serologic diagnosis which will contribute to the improvement of the diagnosis of VL and, consequently, may help in the prevention, control and treatment of the disease in endemic areas of Brazil.

Project description:BackgroundVisceral leishmaniasis (VL) is a neglected parasitic disease that is fatal if left untreated. VL is endemic in Morocco and other countries in North Africa were it mainly affects children from rural areas. In Morocco, the direct observation of Leishmania parasites in bone marrow aspirates and serological tests are used to diagnose VL. Glucantime is the first line of treatment. The objective of this study was to report the costs associated to standard clinical management of pediatric VL from the provider perspective in Morocco. As a secondary objective we described the current clinical practices and the epidemiological characteristics of pediatric VL patients.MethodsFrom March to June 2014 we conducted a survey in eight hospitals treating pediatric VL patients in Morocco. A pro-forma was used to collect demographic, clinical and management data from medical records. We specifically collected data on VL diagnosis and treatment. We also estimated the days of hospitalization and the time to start VL treatment. Costs were estimated by multiplying the use of resources in terms of number of days in hospital, tests performed and drugs provided by the official prices. For patients receiving part of their treatment at Primary Health Centers (PHC) we estimated the cost of administering the Glucantime as outpatient. We calculated the median cost per VL patient. We also estimated the cost of managing a VL case when different treatment strategies were applied: inpatient and outpatient.ResultsWe obtained data from 127 VL patients. The median total cost per pediatric VL case in Morocco is 520 US$. The cost in hospitals applying an outpatient strategy is significantly lower (307 US$) than hospitals keeping the patients for the whole treatment (636 US$). However the outpatient strategy is not yet recommended as VL treatment for children in the Moroccan guidelines. VL diagnosis and treatment regimens should be standardized following the current guidelines in Morocco.

Project description:To estimate the cost-effectiveness of available diagnosis alternatives for Mucosal Leishmaniasis (ML) in Colombian suspected patients. A simulation model of the disease's natural history was built with a decision tree and Markov models. The model´s parameters were identified by systematic review and validated by expert consensus. A bottom-up cost analysis to estimate the costs of diagnostic strategies and treatment per case was performed by reviewing 48 clinical records of patients diagnosed with ML. The diagnostic strategies compared were as follows: 1) no diagnosis; 2) parasite culture, biopsy, indirect immunofluorescence assay (IFA), and Montenegro skin test (MST) combined ; 3) parasite culture, biopsy, and IFA combined; 4) PCR-miniexon; and 5) PCR-kDNA. Three scenarios were modeled in patients with ML clinical suspicion, according to ML prevalence scenarios: high, medium and low. Adjusted sensitivity and specificity parameters of a combination of diagnostic tests were estimated with a discrete event simulation (DES) model. For each alternative, the costs and health outcomes were estimated. The time horizon was life expectancy, considering the average age at diagnosis of 31 years. Incremental cost-effectiveness ratios (ICERs) were calculated per Disability Life Year (DALY) avoided, and deterministic and probabilistic sensitivity analyses were performed. A threshold of willingness to pay (WTP) of three-time gross domestic product per capita (GDPpc) (US$ 15,795) and a discount rate of 3% was considered. The analysis perspective was the third payer (Health System). All costs were reported in American dollars as of 2015. PCR- kDNA was the cost-effective alternative in clinical suspicion levels: low, medium and high with ICERs of US$ 7,909.39, US$ 5,559.33 and US$ 4,458.92 per DALY avoided, respectively. ML diagnostic tests based on PCR are cost-effective strategies, regardless of the level of clinical suspicion. PCR-kDNA was the most cost-effective strategy in the competitive scenario with the parameters included in the present model.

Project description:In the Americas, visceral leishmaniasis (VL) is caused by the protozoan Leishmania infantum, leading to death if not promptly diagnosed and treated. In Brazil, the disease reaches all regions, and in 2020, 1,933 VL cases were reported with 9.5% lethality. Thus, an accurate diagnosis is essential to provide the appropriate treatment. Serological VL diagnosis is based mainly on immunochromatographic tests, but their performance may vary by location, and evaluation of diagnostic alternatives is necessary. In this study, we aimed to evaluate the performance of ELISA with the scantily studied recombinant antigens, K18 and KR95, comparing their performance with the already known rK28 and rK39. Sera from parasitologically confirmed symptomatic VL patients (n = 90) and healthy endemic controls (n = 90) were submitted to ELISA with rK18 and rKR95. Sensitivity (95% CI) was, respectively, 83.3% (74.2-89.7) and 95.6% (88.8-98.6), and specificity (95% CI) was 93.3% (85.9-97.2) and 97.8% (91.8-99.9). For validation of ELISA with the recombinant antigens, we included samples from 122 VL patients and 83 healthy controls collected in three regions in Brazil (Northeast, Southeast, and Midwest). When comparing the results obtained with the VL patients' samples, significantly lower sensitivity was obtained by rK18-ELISA (88.5%, 95% CI: 81.5-93.2) compared with rK28-ELISA (95.9%, 95% CI: 90.5-98.5), but the sensitivity was similar comparing rKR95-ELISA (95.1%, 95% CI: 89.5-98.0), rK28-ELISA (95.9%, 95% CI: 90.5-98.5), and rK39-ELISA (94.3%, 95% CI: 88.4-97.4). Analyzing the specificity, it was lowest with rK18-ELISA (62.7%, 95% CI: 51.9-72.3) with 83 healthy control samples. Conversely, higher and similar specificity was obtained by rKR95-ELISA (96.4%, 95% CI: 89.5-99.2), rK28-ELISA (95.2%, 95% CI: 87.9-98.5), and rK39-ELISA (95.2%, 95% CI: 87.9-98.5). There was no difference in sensitivity and specificity across localities. Cross-reactivity assessment, performed with sera of patients diagnosed with inflammatory disorders and other infectious diseases, was 34.2% with rK18-ELISA and 3.1% with rKR95-ELISA. Based on these data, we suggest using recombinant antigen KR95 in serological assays for VL diagnosis.

Dataset Information

Cost-effectiveness of serological tests for human visceral leishmaniasis in the Brazilian scenario.

Publications

Cost-effectiveness of serological tests for human visceral leishmaniasis in the Brazilian scenario.

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