ABSTRACT Timely and accurate diagnosis is one of the strategies for managing visceral leishmaniasis (VL). Given the specificities of this infection, which affects different vulnerable populations, the local assessment of the accuracy of the available diagnostic test is a requirement for the good use of resources. In Brazil, performance data are required for test registration with the National Regulatory Agency (ANVISA), but there are no minimum requirements established for performance evaluation. Here, we compared the accuracy reported in the manufacturer’s instructions of commercially available VL-diagnostic tests in Brazil, and the accuracies reported in the scientific literature which were obtained after test commercialization. The tests were identified via the electronic database of ANVISA, and their accuracy was obtained from the manufacturer’s instructions. A literature search for test accuracy was performed using two databases. A total of 28 VL diagnostic tests were identified through the ANVISA database. However, only 13 presented performance data in the manufacturer’s instructions, with five immunoenzymatic tests, three indirect immunofluorescence tests, one chemiluminescence test, and four rapid tests. For most tests, the manufacturers did not provide the relevant information, such as sample size, reference standards, and study site. The literature review identified accuracy data for only 61.5% of diagnostic tests registered in Brazil. These observations confirmed that there are significant flaws in the process of registering health technologies and highlighted one of the reasons for the insufficient control of policies, namely, the use of potentially inaccurate and inappropriate diagnostic tools for a given scenario. VL. . (VL) infection populations resources Brazil , (ANVISA) evaluation Here manufacturer s VLdiagnostic commercialization databases 2 However 1 information size standards site 615 61 5 61.5 policies namely scenario (VL (ANVISA 6 61.

Abstract Over the years, aircraft and spacecraft designs incorporated highly integrated and/or complex systems that can manage complex scenarios during its operation. In addition to the inherent complexity and/or high level of integration of those systems, the development process applied to aerospace programs is also challenged by other factors: program schedule, budget, multidisciplinary teams, new industry emerging technologies, large number of different processes and procedures that guide the activities along the development life cycle, and others. Given the fact many tasks executed during the development of such systems require human interaction, that yields the introduction of design errors that can contribute to the occurrence of non-desired system behaviors during operation phase. It is already recognized by the civil aviation industry that it is unfeasible to have a deterministic test set to demonstrate that such systems are completely free of such design errors. In that context, a huge effort is applied by the industry, by using qualitative methods to mitigate the occurrence of design errors during the development phases. This paper discusses how MBSE methodology applied together with a design assurance process could prevent such design errors, and presents an analysis showing how some events in aerospace industry where a design error was one of the contributing factors could be avoided.

ABSTRACT Neglected tropical diseases (NTDs) are those affecting vulnerable people and causing additional social and economic burden. The aim of this study was to carry out a general overview of the health economic assessments involving the diagnosis and treatment of six NTDs: cutaneous leishmaniasis (CL), Chagas disease, cysticercosis, filariasis, schistosomiasis and visceral leishmaniasis (VL). The literature search was based on two of the main medical literature databases (Medline and SciELO) and identified 46 studies. Twenty-six studies (57%) addressed therapeutic strategies, while other 20 (43%) assessed diagnostic or both diagnostic and therapeutic approaches. The studies were published between 1994 and 2021, and 57% of them (26/46) were carried out in four countries. Cost-effectiveness analyses were conducted in 59% (27/46) of the studies. Economic studies of NTDs have timidly increased in recent years. Despite the improvement of analytical methods, completeness and accuracy of information, there are few new technologies applied to NTDs and public health systems. In addition, economic studies for NTDs are concentrated in a few countries. Thus, this review points out the need for investment in research, development and training of human resources dedicated to the economic analysis in health, especially on NTDs, as a strategy to reduce inequalities by optimizing the use of health resources.

A leishmaniose cutânea (LC) é uma doença associada a populações de baixa renda. Portanto, a inclusão do impacto financeiro sobre os pacientes é muito importante para avaliar a carga dessa doença. Tivemos como objetivo avaliar o impacto econômico da LC em pacientes afetados pela doença e tratados em um centro de referência para LC no Estado de Minas Gerais, Brasil. Foi um estudo transversal com base em análise de entrevistas e prontuários médicos para compilação dos gastos médicos e não médicos diretos relacionados à LC, desde uma perspectiva societal. Foram incluídos cem pacientes; 50% tinham renda mensal per capita de até USD 259,60. O gasto médio na doença foi de USD 187,32, o que representa um impacto mensal médio de 22,5% (USD 133,80). A doença impôs custos médicos diretos, como o pagamento por consultas médicas particulares, exames médicos, material para curativos e co-participação em seguro de saúde. Os custos não médicos diretos estiveram relacionados ao transporte dos pacientes até os centros de saúde, cuidados adicionais, alimentação e contratos com serviços terceirizados para atividades domésticas e laborais. O transporte dos pacientes para as consultas médicas representava a principal parcela dos gastos (USD 4.911,00). Embora o acesso à assistência à saúde seja um direito garantido pelo Sistema Único de Saúde, a LC ainda gera um impacto financeiro substancial para os pacientes. A descentralização dos serviços diagnósticos e terapêuticos para LC e o aumento de sua eficiência são as principais medidas que podem reduzir os gastos com essa doença.

Cutaneous leishmaniasis (CL) is a disease associated with low-income populations. Thus, in assessing the burden of this disease, it is important to include its economic impact on individuals. We aimed to evaluate CL economic impact on patients treated at a referral service in the State of Minas Gerais, Brazil. This is a cross-sectional study based on the analysis of interviews and medical records from which we assembled direct medical and non-medical costs related to CL, from a societal perspective. One hundred patients were included; 50% had a monthly per capita income of up to USD 259.60 and spent on average USD 187.32 with the disease, representing an average monthly impact of 22.5% (USD 133.80). The disease imposed direct medical costs, such as: private medical appointments, medications, medical exams, dressing material, and co-participation in health insurances. Direct non-medical costs were mainly related to patients’ transportation to health centers (USD 4,911.00), but also included medically-necessary care, food, and domestic and business outsourcing services. Although the Brazilian public health system guarantees access to health care, CL still represents a substantial economic impact for patients. The main action to reduce the expenses with this disease is decentralizing services for CL diagnosis and therapeutic approach, as well as increasing their efficiency.

La leishmaniosis cutánea (LC) es una enfermedad asociada a poblaciones con ingresos bajos. Por ello, incluir el impacto financiero para las personas es muy importante a la hora de evaluar la carga de esta enfermedad. Nuestro objetivo fue evaluar el impacto económico de la LC, de pacientes afectados por esta enfermedad, que fueron tratados por un servicio de referencia para el tratamiento de la LC en el Estado de Minas Gerais, Brasil. Este estudio transversal basado en entrevistas y análisis de registros médicos para la recopilación de gastos médicos y no-médicos directos, relacionados con la LC desde una a perspectiva social. Se incluyeron a cien pacientes; el 50% contaba con ingresos mensuales per cápita de hasta USD 259,60 y gastaban un promedio de USD 187,32 en la enfermedad, representando un impacto promedio mensual de 22,5% (USD 133,80). La enfermedad supuso costes médicos directos, como el pago de citas médicas privadas, medicamentos, exámenes médicos, material para vendajes, y coparticipación en seguros médicos. Los costes directos no-médicos estaban relacionados con el transporte de los pacientes a los centros de salud, el cuidado necesario, comida, y contratos con servicios externalizados para actividades domésticas y laborales. El transporte de los pacientes para citas médicas representó la principal razón para los gastos (USD 4.911,00). A pesar de que el acceso a los cuidados de salud es un derecho garantizado por el sistema de salud público brasileño, la LC todavía supone un impacto financiero importante para los pacientes. La descentralización de los servicios para el diagnóstico de LC, la aproximación terapéutica, y el incremento de su eficiencia, son las acciones con principal potencial para reducir los gastos financieros de esta enfermedad.

A leishmaniose cutânea (LC) é uma doença associada a populações de baixa renda. Portanto, a inclusão do impacto financeiro sobre os pacientes é muito importante para avaliar a carga dessa doença. Tivemos como objetivo avaliar o impacto econômico da LC em pacientes afetados pela doença e tratados em um centro de referência para LC no Estado de Minas Gerais, Brasil. Foi um estudo transversal com base em análise de entrevistas e prontuários médicos para compilação dos gastos médicos e não médicos diretos relacionados à LC, desde uma perspectiva societal. Foram incluídos cem pacientes; 50% tinham renda mensal per capita de até USD 259,60. O gasto médio na doença foi de USD 187,32, o que representa um impacto mensal médio de 22,5% (USD 133,80). A doença impôs custos médicos diretos, como o pagamento por consultas médicas particulares, exames médicos, material para curativos e co-participação em seguro de saúde. Os custos não médicos diretos estiveram relacionados ao transporte dos pacientes até os centros de saúde, cuidados adicionais, alimentação e contratos com serviços terceirizados para atividades domésticas e laborais. O transporte dos pacientes para as consultas médicas representava a principal parcela dos gastos (USD 4.911,00). Embora o acesso à assistência à saúde seja um direito garantido pelo Sistema Único de Saúde, a LC ainda gera um impacto financeiro substancial para os pacientes. A descentralização dos serviços diagnósticos e terapêuticos para LC e o aumento de sua eficiência são as principais medidas que podem reduzir os gastos com essa doença.

La leishmaniosis cutánea (LC) es una enfermedad asociada a poblaciones con ingresos bajos. Por ello, incluir el impacto financiero para las personas es muy importante a la hora de evaluar la carga de esta enfermedad. Nuestro objetivo fue evaluar el impacto económico de la LC, de pacientes afectados por esta enfermedad, que fueron tratados por un servicio de referencia para el tratamiento de la LC en el Estado de Minas Gerais, Brasil. Este estudio transversal basado en entrevistas y análisis de registros médicos para la recopilación de gastos médicos y no-médicos directos, relacionados con la LC desde una a perspectiva social. Se incluyeron a cien pacientes; el 50% contaba con ingresos mensuales per cápita de hasta USD 259,60 y gastaban un promedio de USD 187,32 en la enfermedad, representando un impacto promedio mensual de 22,5% (USD 133,80). La enfermedad supuso costes médicos directos, como el pago de citas médicas privadas, medicamentos, exámenes médicos, material para vendajes, y coparticipación en seguros médicos. Los costes directos no-médicos estaban relacionados con el transporte de los pacientes a los centros de salud, el cuidado necesario, comida, y contratos con servicios externalizados para actividades domésticas y laborales. El transporte de los pacientes para citas médicas representó la principal razón para los gastos (USD 4.911,00). A pesar de que el acceso a los cuidados de salud es un derecho garantizado por el sistema de salud público brasileño, la LC todavía supone un impacto financiero importante para los pacientes. La descentralización de los servicios para el diagnóstico de LC, la aproximación terapéutica, y el incremento de su eficiencia, son las acciones con principal potencial para reducir los gastos financieros de esta enfermedad.

Cutaneous leishmaniasis (CL) is a disease associated with low-income populations. Thus, in assessing the burden of this disease, it is important to include its economic impact on individuals. We aimed to evaluate CL economic impact on patients treated at a referral service in the State of Minas Gerais, Brazil. This is a cross-sectional study based on the analysis of interviews and medical records from which we assembled direct medical and non-medical costs related to CL, from a societal perspective. One hundred patients were included; 50% had a monthly per capita income of up to USD 259.60 and spent on average USD 187.32 with the disease, representing an average monthly impact of 22.5% (USD 133.80). The disease imposed direct medical costs, such as: private medical appointments, medications, medical exams, dressing material, and co-participation in health insurances. Direct non-medical costs were mainly related to patients’ transportation to health centers (USD 4,911.00), but also included medically-necessary care, food, and domestic and business outsourcing services. Although the Brazilian public health system guarantees access to health care, CL still represents a substantial economic impact for patients. The main action to reduce the expenses with this disease is decentralizing services for CL diagnosis and therapeutic approach, as well as increasing their efficiency.

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.

Abstract INTRODUCTION: Visceral leishmaniasis (VL) is fatal if not diagnosed and treated. This study aimed to estimate the cost-effectiveness of diagnostic-therapeutic alternatives for VL in Brazil. METHODS: A decision model estimated the life expectancy and costs of six diagnostic-therapeutic strategies. RESULTS: IT LEISH + liposomal amphotericin B emerged the best option, presenting lower costs and higher effectiveness. DAT-LPC + liposomal amphotericin B showed an incremental cost-effectiveness ratio of US$ 326.31 per life year. CONCLUSIONS: These findings indicate the feasibility of incorporating DAT and designating liposomal amphotericin B as the first-line drug for VL in Brazil.

The population of Brazil is currently characterised by many individuals harbouring low-intensity Schistosoma mansoni infections. The Kato-Katz technique is the diagnostic method recommended by the World Health Organization (WHO) to assess these infections, but this method is not sensitive enough in the context of low egg excretion. In this regard, potential alternatives are being employed to overcome the limits of the Kato-Katz technique. In the present review, we evaluated the performance of parasitological and immunological approaches adopted in Brazilian areas. Currently, the diagnostic choices involve a combination of strategies, including the utilisation of antibody methods to screen individuals and then subsequent confirmation of positive cases by intensive parasitological investigations.

Abstract INTRODUCTION Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to report therapeutic responses with different available options for ML. METHODS This study was based on a review of clinical records of 35 patients (24 men and 11 women) treated between 2009 and 2015. RESULTS The median age of patients was 63 years, and the median duration of the disease was 24 months. Seventeen patients received Sbv, while nine patients were treated with liposomal amphotericin B (AmB), and another nine patients were treated with fluconazole. Patients treated with AmB received a total median accumulated dose of 2550mg. The mean duration of azole use was 120 days, and the daily dose ranged from 450 to 900mg. At the three-month follow-up visit, the cure rate was 35%, 67%, and 22% for Sbv, AmB, and azole groups, respectively. At the six-month follow-up visit, the cure rates for Sbv, AmB, and azole groups were 71%, 78%, and 33%, respectively. CONCLUSIONS There is a scarcity of effective ML treatment alternatives, and based on our observations, fluconazole is not a valid treatment option.

BACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure. METHODS The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed. FINDINGS The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result. CONCLUSIONS The procedure is reproducible and can be used by professionals without previous training with high success and safety rates.

BACKGROUND Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).

ABSTRACT Immunochromatographic tests based on the recombinant antigen K39 represent a major advance in diagnosing visceral leishmaniasis (VL) in recent years. Some performance variations are expected and have occurred in the use of several commercial rapid tests, especially in different geographical settings. This is the first evaluation in the Americas of the test recently provided by the public health system in Brazil for the diagnostic of VL, the OnSite™ Leishmania IgG/IgM Combo. In this first clinical test evaluation, 113 VL-positive patient samples and 73 negative controls were tested and a sensitivity of 91.2% and specificity of 94.5% were observed. These results indicate the need for further analysis and comparisons with the performance of other available commercial tests in order to define the impact of this new test on the quality of VL diagnosis in Brazil.

Abstract INTRODUCTION: The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The aim of this study was to estimate the direct costs of therapies recommended by the Ministry of Health (MH) for VL treatment in Brazil. METHODS: The analytical perspective used was that adopted by the Brazilian Public Health System. Three drugs and four regimens were included: 1) N-methyl glucamine antimoniate intramuscularly at 20mg per kg per day for 30 days; 2) N-methyl glucamine antimoniate intravenously at 20mg per kg per day for 30 days; 3) amphotericin B deoxycholate at 1mg per kg per day for 21 days; and 4) liposomal amphotericin B at 3mg per kg per day for a 7 days treatment. RESULTS: The estimated direct costs of treatment for an adult patient using N-methylglucamine antimoniate administered via the intramuscular and intravenous routes were USD 418.52 and USD 669.40, respectively. The estimated cost of treatment with amphotericin B deoxycholate was USD 1,522.70. Finally, the estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. CONCLUSIONS: This analysis indicates the economic feasibility of replacing N-methyl glucamine antimoniate with liposomal amphotericin B, which allows a shorter treatment period with less toxicity compared with other treatments, provided that the purchase value used by the WHO and transferred to the MH is maintained.

Resumo: O estudo teve como objetivo estimar os custos financeiros da incorporação e/ou substituição dos testes diagnósticos para a leishmaniose visceral (LV) humana no Brasil. A análise foi realizada na perspectiva do Sistema Único de Saúde (SUS) ao longo de três anos. Foram avaliados seis testes diagnósticos: reação de imunofluorescência indireta (RIFI), teste rápido IT LEISH, exame parasitológico de aspirado de medula óssea, teste de aglutinação direta DAT-LPC padronizado pelo Laboratório de Pesquisas Clínicas do Instituto René Rachou, Fundação Oswaldo Cruz, teste rápido Kalazar Detect e reação em cadeia da polimerase (PCR). Os parâmetros utilizados foram o número de casos suspeitos de LV notificados ao Ministério da Saúde em 2014 e o custo direto dos testes diagnósticos. Os custos do diagnóstico de casos suspeitos de LV ao longo de três anos usando o RIFI e DAT-LPC foram estimados em USD 280.979,91 e USD 121.371,48, respectivamente. De acordo com a análise, comparado ao uso do RIFI, a incorporação do DAT-LPC pelo SUS resultaria numa economia de USD 159.608,43. Com relação ao impacto dos testes rápidos, o uso do IT LEISH resultou em economia de USD 21.708,72 ao longo de três anos. Comparado ao exame parasitológico, o diagnóstico com PCR resultou em economia de USD 3.125.068,92 ao longo de três anos. Neste estudo, a substituição do RIFI pelo DAT-LPC mostrou ser financeiramente vantajosa. Além disso, a substituição do teste rápido Kalazar Detect com o IT LEISH em 2015 foi economicamente apropriada, e a substituição do exame parasitológico pela PCR está economicamente indicada.

Abstract: The aim of the present study was to estimate the financial costs of the incorporation and/or replacement of diagnostic tests for human visceral leishmaniasis (VL) in Brazil. The analysis was conducted from the perspective of the Brazilian Unified National Health System (SUS) over a period of three years. Six diagnostic tests were evaluated: the indirect immunofluorescence antibody test (IFAT), the IT LEISH rapid test, the parasitological examination of bone marrow aspirate, the direct agglutination test (DAT-LPC) standardized in the Clinical Research Laboratory, René Rachou Institute of the Oswaldo Cruz Foundation, the Kalazar Detect rapid test, and polymerase chain reaction (PCR). The assumptions used were the number of suspected cases of VL reported to the Brazilian Ministry of Health in 2014 and the direct cost of diagnostic tests. The costs to diagnose suspected cases of VL over three years using the IFAT and the DAT-LPC were estimated at USD 280,979.91 and USD 121,371.48, respectively. The analysis indicated that compared with the use of the IFAT, the incorporation of the DAT-LPC into the SUS would result in savings of USD 159,608.43. With regard to the budgetary impact of rapid tests, the use of IT LEISH resulted in savings of USD 21.708,72 over three years. Compared with a parasitological examination, diagnosis using PCR resulted in savings of USD 3,125,068.92 over three years. In this study, the replacement of the IFAT with the DAT-LPC proved financially advantageous. In addition, the replacement of the Kalazar Detect rapid test with the IT LEISH in 2015 was economically valuable, and the replacement of parasitological examination with PCR was indicated.

Resumen: El objetivo del estudio fue estimar los costes financieros de la incorporación y/o sustitución de las pruebas diagnósticas para la leishmaniasis visceral (LV) humana en Brasil. El análisis se realizó desde la perspectiva del Sistema Único de Salud (SUS) a lo largo de tres años. Se evaluaron seis pruebas diagnósticas: reacción de inmunofluorescencia indirecta (RIFI), test rápido IT LEISH, examen parasitológico de aspirado de medula ósea, test de aglutinación directa DAT-LPC, estandarizado por el Laboratorio de Investigación Clínica del Centro de Investigación René Rachou, Fundación Oswaldo Cruz, test rápido Kalazar Detect y la reacción en cadena de la polimerasa (PCR). Los parámetros utilizados fueron el número de casos sospechosos de LV notificados al Ministerio de Salud en 2014 y el coste directo de los test diagnósticos. Los costes del diagnóstico de casos sospechosos de LV a lo largo de tres años, usando el RIFI y DAT-LPC, se estimaron en USD 280.979,91 y USD 121.371,48, respectivamente. De acuerdo con el análisis, comparado con el uso del RIFI, la incorporación del DAT-LPC por el SUS resultaría en un ahorro de USD 159.608,43. En relación con el impacto de los test rápidos, el uso del IT LEISH aportaba un ahorro de USD 21.708,72 a lo largo de tres años. Comparado con el examen parasitológico, el diagnóstico con PCR suponía un ahorro de USD 3.125.068,92 a lo largo de tres años. De acuerdo con el estudio, la sustitución del RIFI con el DAT-LPC mostró ser financieramente ventajosa. Asimismo, la sustitución del test rápido Kalazar Detect con el IT LEISH en 2015 representó un ahorro económico, y los resultados favorecieron la sustitución del examen parasitológico con PCR.

Resumo: O estudo teve como objetivo estimar os custos financeiros da incorporação e/ou substituição dos testes diagnósticos para a leishmaniose visceral (LV) humana no Brasil. A análise foi realizada na perspectiva do Sistema Único de Saúde (SUS) ao longo de três anos. Foram avaliados seis testes diagnósticos: reação de imunofluorescência indireta (RIFI), teste rápido IT LEISH, exame parasitológico de aspirado de medula óssea, teste de aglutinação direta DAT-LPC padronizado pelo Laboratório de Pesquisas Clínicas do Instituto René Rachou, Fundação Oswaldo Cruz, teste rápido Kalazar Detect e reação em cadeia da polimerase (PCR). Os parâmetros utilizados foram o número de casos suspeitos de LV notificados ao Ministério da Saúde em 2014 e o custo direto dos testes diagnósticos. Os custos do diagnóstico de casos suspeitos de LV ao longo de três anos usando o RIFI e DAT-LPC foram estimados em USD 280.979,91 e USD 121.371,48, respectivamente. De acordo com a análise, comparado ao uso do RIFI, a incorporação do DAT-LPC pelo SUS resultaria numa economia de USD 159.608,43. Com relação ao impacto dos testes rápidos, o uso do IT LEISH resultou em economia de USD 21.708,72 ao longo de três anos. Comparado ao exame parasitológico, o diagnóstico com PCR resultou em economia de USD 3.125.068,92 ao longo de três anos. Neste estudo, a substituição do RIFI pelo DAT-LPC mostrou ser financeiramente vantajosa. Além disso, a substituição do teste rápido Kalazar Detect com o IT LEISH em 2015 foi economicamente apropriada, e a substituição do exame parasitológico pela PCR está economicamente indicada.

Resumen: El objetivo del estudio fue estimar los costes financieros de la incorporación y/o sustitución de las pruebas diagnósticas para la leishmaniasis visceral (LV) humana en Brasil. El análisis se realizó desde la perspectiva del Sistema Único de Salud (SUS) a lo largo de tres años. Se evaluaron seis pruebas diagnósticas: reacción de inmunofluorescencia indirecta (RIFI), test rápido IT LEISH, examen parasitológico de aspirado de medula ósea, test de aglutinación directa DAT-LPC, estandarizado por el Laboratorio de Investigación Clínica del Centro de Investigación René Rachou, Fundación Oswaldo Cruz, test rápido Kalazar Detect y la reacción en cadena de la polimerasa (PCR). Los parámetros utilizados fueron el número de casos sospechosos de LV notificados al Ministerio de Salud en 2014 y el coste directo de los test diagnósticos. Los costes del diagnóstico de casos sospechosos de LV a lo largo de tres años, usando el RIFI y DAT-LPC, se estimaron en USD 280.979,91 y USD 121.371,48, respectivamente. De acuerdo con el análisis, comparado con el uso del RIFI, la incorporación del DAT-LPC por el SUS resultaría en un ahorro de USD 159.608,43. En relación con el impacto de los test rápidos, el uso del IT LEISH aportaba un ahorro de USD 21.708,72 a lo largo de tres años. Comparado con el examen parasitológico, el diagnóstico con PCR suponía un ahorro de USD 3.125.068,92 a lo largo de tres años. De acuerdo con el estudio, la sustitución del RIFI con el DAT-LPC mostró ser financieramente ventajosa. Asimismo, la sustitución del test rápido Kalazar Detect con el IT LEISH en 2015 representó un ahorro económico, y los resultados favorecieron la sustitución del examen parasitológico con PCR.

Abstract: The aim of the present study was to estimate the financial costs of the incorporation and/or replacement of diagnostic tests for human visceral leishmaniasis (VL) in Brazil. The analysis was conducted from the perspective of the Brazilian Unified National Health System (SUS) over a period of three years. Six diagnostic tests were evaluated: the indirect immunofluorescence antibody test (IFAT), the IT LEISH rapid test, the parasitological examination of bone marrow aspirate, the direct agglutination test (DAT-LPC) standardized in the Clinical Research Laboratory, René Rachou Institute of the Oswaldo Cruz Foundation, the Kalazar Detect rapid test, and polymerase chain reaction (PCR). The assumptions used were the number of suspected cases of VL reported to the Brazilian Ministry of Health in 2014 and the direct cost of diagnostic tests. The costs to diagnose suspected cases of VL over three years using the IFAT and the DAT-LPC were estimated at USD 280,979.91 and USD 121,371.48, respectively. The analysis indicated that compared with the use of the IFAT, the incorporation of the DAT-LPC into the SUS would result in savings of USD 159,608.43. With regard to the budgetary impact of rapid tests, the use of IT LEISH resulted in savings of USD 21.708,72 over three years. Compared with a parasitological examination, diagnosis using PCR resulted in savings of USD 3,125,068.92 over three years. In this study, the replacement of the IFAT with the DAT-LPC proved financially advantageous. In addition, the replacement of the Kalazar Detect rapid test with the IT LEISH in 2015 was economically valuable, and the replacement of parasitological examination with PCR was indicated.