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.

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.