Mariana Lourenço Freire, Maria Clara de Oliveira Gonçalves, Allana Carolina Marques da Silva, Gláucia Cota, Ana Rabello, Tália Santana Machado de Assis
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...
2023: Revista da Sociedade Brasileira de Medicina Tropical