Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?

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.

Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?

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.

Economic impact of localized cutaneous leishmaniasis on adult patients of a referral service in Belo Horizonte, Minas Gerais State, Brazil.

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.

Economic impact of localized cutaneous leishmaniasis on adult patients of a referral service in Belo Horizonte, Minas Gerais State, Brazil / Impacto econômico da leishmaniose cutânea localizada em pacientes adultos em um serviço de referência em Belo Horizonte, Minas Gerais, Brasil / Impacto económico de la leishmaniosis cutánea localizada que afecta a pacientes adultos en un servicio de referencia en Belo Horizonte, Minas Gerais, Brasil

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.

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.

Cost-effectiveness analysis of diagnostic-therapeutic strategies for visceral leishmaniasis in Brazil.

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.

Desafios da implantação de testes rápidos para o diagnóstico da leishmaniose visceral em serviços de saúde de município endêmico para a doença / Challenges of the implantation of rapid tests for the diagnosis of visceral leishmaniasis in health services of a municipality endemic to the disease

O objetivo deste estudo foi descrever e discutir fatores facilitadores e desafios enfrentados durante o processo de incorporação de um teste rápido para o diagnóstico da leishmaniose visceral (LV) humana em serviços de saúde de município endêmico para a doença no Brasil. Este estudo foi dividido em quatro eixos de análise, seguindo as etapas de execução do estudo: 1) Descrição do sistema de saúde local e da tecnologia a ser implantada; 2) Contexto e atividades preparatórias; 3) Resultados da avaliação da implantação, da aceitação e do desempenho do algoritmo diagnóstico; 4) Conclusões, considerações e recomendações. O estudo foi conduzido em Ribeirão das Neves, no estado de Minas Gerais; o teste rápido implantado, o IT LEISH®, executado a partir de sangue capilar. Impasses e desafios estiveram relacionados à recusa de profissionais de saúde em realizar o IT LEISH® durante as capacitações, como dificuldade no processo de compra do teste rápido e atraso na entrega, dificuldades para coleta do sangue capilar relatada por pacientes e profissionais de saúde e falta de clareza entre os profissionais sobre suas atribuições e responsabilidades nas unidades de saúde, além de evasão de pacientes para cidade de maior porte. Este estudo apontou para a viabilidade da implantação de um teste rápido que descentralizasse e favorecesse o acesso ao diagnóstico laboratorial da LV. No entanto, no período do estudo, a maioria dos casos de LV residentes em Ribeirão das Neves foi diagnosticada em outro município, Belo Horizonte. Tal constatação aponta para desarticulação interna envolvendo os serviços de saúde do município, seja no acolhimento e na identificação dos suspeitos de LV, seja na efetiva utilização dos recursos disponíveis. Mesmo assim, identificamos dois aspectos determinantes para a realização da implantação: o engajamento de profissionais lotados em setores estratégicos da gestão municipal e a existência de financiamento. Estes resultados demonstram a complexidade do processo de implantação de uma nova tecnologia e apontam para a necessidade de trabalho integrado. Do contrário, a disponibilidade de testes rápidos para LV não será suficiente para garantir acesso e redução da letalidade pela doença.

This study aims to describe and discuss facilitating factors and challenges faced during the process of incorporating a rapid test for the diagnosis of human visceral leishmaniasis (VL) in health services of a municipality endemic to the disease in Brazil. This study was divided in four axis of analysis, following the study stages of execution: 1) Description of the local health system and the technology to be implemented; 2) Context and preparatory activities; 3) Results of evaluation of the implementation, acceptance and performance of the diagnostic algorithm; 4) Conclusions, considerations and recommendations. The study was conducted in Ribeirão das Neves, Minas Gerais and the rapid test implanted was IT LEISH®, performed from capillary blood. Impasses and challenges were related to the refusal of health professionals to perform IT LEISH® during training, difficulty in purchasing the rapid test and its delayed delivery, difficulties in capillary blood collection reported by patients and health professionals, lack of clarity among the professionals regarding their duties and responsibilities in health units, as well as avoidance of patients to a larger city. This study pointed to the feasibility of the implantation of a rapid test that decentralizes and favors the access to laboratory diagnosis of VL. However, in the study period, the majority of VL cases residing in Ribeirão das Neves were diagnosed in another municipality, Belo Horizonte. This finding points to internal disarticulation involving the health services of the municipality, either in the reception and identification of suspected LV, or in the effective use of available resources. Even so, we identified two determinant aspects for the implementation: the engagement of crowded professionals in strategic sectors of municipal management and the existence of financing. These results demonstrate the complexity of the process of implementing a new technology and point to the necessity of integrated work. Otherwise, the availability of rapid tests for LV will not be enough to guarantee access and reduction of disease lethality.

Cost-effectiveness analysis of diagnostic-therapeutic strategies for visceral leishmaniasis 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.

Evaluation of a new brand of immunochromatographic test for visceral leishmaniasis in Brazil made available from 2018.

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.

Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil.

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.

The direct costs of treating human visceral leishmaniasis in Brazil.

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.

The direct costs of treating human visceral leishmaniasis 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.

Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil / Impacto orçamentário dos testes diagnósticos para leishmaniose visceral no Brasil / Impacto presupuestario de las pruebas diagnósticas para la leishmaniosis visceral en Brasil

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.

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.

Study of implementation and direct cost estimates for diagnostic tests for human visceral leishmaniasis in an urban area in Brazil / Estudo da implantação e estimativas de custo direto de testes diagnósticos para leishmaniose visceral humana em uma área urbana no Brasil / Estudio de la implementación y el costo directo estimado de pruebas de diagnóstico de la leishmaniasis visceral humana en una zona urbana en Brasil

Abstract This work reports the process and costs of comprehensively implementing two tests to decentralize the diagnosis of visceral leishmaniasis (VL) in an endemic city in Brazil: a rapid test (IT LEISH) and a direct agglutination test (DAT-LPC). The implementation began by training health professionals to perform the tests. Estimation of the training costs considered the proportional remuneration of all professionals involved and the direct costs of the tests used for training. The study was conducted between November 2011 and November 2013. During that time, 17 training sessions were held, and 175 professionals were trained. The training cost for each professional was US$ 7.13 for the IT LEISH and US$ 9.93 for the DAT-LPC. The direct costs of the IT LEISH and DAT-LPC were estimated to be US$ 6.62 and US$ 5.44, respectively. This first evaluation of the implementation of these diagnostic tests indicates the feasibility of decentralizing both methods to extend access to VL diagnosis in Brazil.

Resumo Este trabalho relata o processo e os custos da implantação de dois testes para descentralizar o diagnóstico da leishmaniose visceral (LV) em um município endêmico no Brasil: um teste rápido (IT LEISH) e um teste de aglutinação direta (DAT-LPC). A implantação iniciou com o treinamento dos profissionais de saúde do município na realização dos testes diagnósticos. Os itens incluídos nas estimativas de custo das capacitações foram a remuneração proporcional de todos os profissionais envolvidos e os custos diretos dos testes usados. O estudo foi conduzido entre novembro de 2011 e novembro de 2013. Durante esse período, 17 capacitações foram realizadas e 175 profissionais treinados. O custo relacionado a cada profissional de saúde capacitado na realização do IT LEISH foi de US$ 7,13 e na realização do DAT-LPC, de US$ 9,93. O custo direto do IT LEISH e do DAT-LPC foi estimado em US$ 6,62 e US$ 5,44, respectivamente. Esta primeira avaliação da implantação desses dois testes aponta para a viabilidade da descentralização de ambos os métodos, que aumentam o acesso ao diagnóstico da LV no Brasil.

Resumen Este trabajo relata la puesta en funcionamiento y los costos de pruebas de diagnóstico de VL en un municipio endémico en Brasil: el test rápido (IT LEISH) y la prueba de aglutinación directa (DAT-LPC). Esta puesta en marcha comenzó por capacitar al personal sanitario del municipio para la realización de las pruebas. Para estimar los costos de la capacitación, se consideró la remuneración proporcional de todo el personal involucrado y los costos directos derivados de la aplicación de las pruebas. El estudio fue realizado entre noviembre de 2011 y noviembre de 2013. En ese periodo se realizaron 17 capacitaciones y se formaron 175 profesionales. Se calcula que el costo derivado de capacitar cada profesional para realizar el IT LEISH fue de 7.13 US$ y 9.93 US$ para el DAT-LPC. Los costos directos del IT LEISH y del DAT-LPC se estimaron en 6,62 US$ y 5,44 US$ respectivamente. La primera evaluación de la puesta en funcionamiento de las dos pruebas en este municipio señala que es viable descentralizar su realización, lo que amplía el acceso al diagnóstico de la VL en Brasil.

Study of implementation and direct cost estimates for diagnostic tests for human visceral leishmaniasis in an urban area in Brazil.

This work reports the process and costs of comprehensively implementing two tests to decentralize the diagnosis of visceral leishmaniasis (VL) in an endemic city in Brazil: a rapid test (IT LEISH) and a direct agglutination test (DAT-LPC). The implementation began by training health professionals to perform the tests. Estimation of the training costs considered the proportional remuneration of all professionals involved and the direct costs of the tests used for training. The study was conducted between November 2011 and November 2013. During that time, 17 training sessions were held, and 175 professionals were trained. The training cost for each professional was US$ 7.13 for the IT LEISH and US$ 9.93 for the DAT-LPC. The direct costs of the IT LEISH and DAT-LPC were estimated to be US$ 6.62 and US$ 5.44, respectively. This first evaluation of the implementation of these diagnostic tests indicates the feasibility of decentralizing both methods to extend access to VL diagnosis in Brazil.

Validação de teste rápido para o diagnóstico da leishmaniose visceral humana

O teste imunocromatográfico rápido IT-LEISH® (DiaMed IT-LEISH®) foi validado para o diagnóstico da leishmaniose visceral (LV) em quatro áreas endêmicas do Brasil. O desempenho do IT-LEISH® foi comparado ao da reação de imunofluorescência indireta e da reação imunoenzimática utilizando os antígenos solúveis de Leishmania chagasi e o recombinante K39. Foram incluídos no estudo 332 pacientes com quadro clínico sugestivo de LV, sendo 213 casos de LV confirmados parasitologicamente e 119 não-casos com confirmação de outra etiologia. O teste IT-LEISH® apresentou sensibilidade de 93% e especificidade de 97%. As técnicas RIFI, ELISA L. chagasi e ELISA rK39 apresentaram sensibilidade de 88%, 92% e 97% e especificidades de 81%, 77% e 84%, respectivamente. Os resultados confirmam a validade do teste IT-LEISH® para o diagnóstico da LV no Brasil

Validação do teste imunocromatográfico rápido IT-LEISH® para o diagnóstico da leishmaniose visceral humana / Validation of the rapid immunochromatographic test IT-LEISH® for the diagnosis of human visceral leishmaniasis

O teste imunocromatográfico rápido IT-LEISH® (DiaMed IT-LEISH®) foi validado para o diagnóstico da leishmaniose visceral (LV) em quatro áreas endêmicas do Brasil. O desempenho do IT-LEISH® foi comparado ao da reação de imunofluorescência indireta; e ao da reação imunoenzimática, usando-se antígeno solúvel de Leishmania chagasi e recombinante K39 (rK39). O estudo incluiu 332 pacientes com quadro clínico sugestivo de LV: 213 casos de LV confirmados parasitologicamente; e 119 não-casos, com confirmação de outra etiologia. O teste IT-LEISH® apresentou sensibilidade de 93 por cento e especificidade de 97 por cento. As técnicas RIFI (imunofluorescência indireta), ELISA L. chagasi e ELISA rK39 apresentaram sensibilidade de 88 por cento, 92 por cento e 97 por cento e especificidades de 81 por cento, 77 por cento e 84 por cento, respectivamente. Os resultados confirmam a validade do teste IT-LEISH® para o diagnóstico da LV no Brasil...

Validação de teste rápido para o diagnóstico da leishmaniose visceral humana / Validation testing for the diagnosis of human visceral leishmaniasis

O teste imunocromatográfico rápido IT-LEISH® (DiaMed IT-LEISH®) foi validado para o diagnóstico da leishmaniose visceral (LV) em quatro áreas endêmicas do Brasil. O desempenho do IT-LEISH® foi comparado ao da reação de imunofluorescência indireta e da reação imunoenzimática utilizando os antígenos solúveis de Leishmania chagasi e o recombinante K39. Foram incluídos no estudo 332 pacientes com quadro clínico sugestivo de LV, sendo 213 casos de LV confirmados parasitologicamente e 119 não-casos com confirmação de outra etiologia. O teste IT-LEISH® apresentou sensibilidade de 93% e especificidade de 97%. As técnicas RIFI, ELISA L. chagasi e ELISA rK39 apresentaram sensibilidade de 88%, 92% e 97% e especificidades de 81%, 77% e 84%, respectivamente. Os resultados confirmam a validade do teste IT-LEISH® para o diagnóstico da LV no Brasil