Evaluation Of Rapid Diagnostic Tests For Dengue In Brazil

Introduction: The increasing number of dengue cases worldwide has stimulated the interest to develop products for the diagnosis of this disease in national and international markets. Objective: To evaluate the sensitivity and diagnostic specificity of immunochromatographic Rapid Tests (RT) for the detection of NS1 antigen (Ag), antibodies (Ab) IgG and IgM of dengue virus (DENV), and for the detection of combined AgNS1/AbIgG/IgM received from May 2016 to December 2018 at the National Institute for Quality Control in Health from Oswaldo Cruz Foundation for previous analysis and registration by the National Health Surveillance Agency (Anvisa) from Brazil. Method: The evaluation was performed using true positive and true negative samples for Ag NS1, Ab IgM and IgG to DENV, commercial performance panels and international standard of the National Institute for Biological Standards and Control/World Health Organization (NIBSC/WHO). RT that presented sensitivity and/or specificity values higher than or equal to those stated by the manufacturers were considered satisfactory and those with lower values were unsatisfactory. Results: A total of 32 RT were evaluated, 23 (71.9%) were satisfactory for sensitivity and specificity, 9 (39.1%) for NS1, 11 (47.8%) for IgG/IgM and 3 (13.0%) for the combined detection NS1/IgG/IgM. From 9 RT considered unsatisfactory, 4 (44.4%) were for the detection of NS1; 2 (22.2%) for IgG/IgM and 3 (33.3%) for NS1/IgG/IgM. Unsatisfactory RT were not registered by Anvisa in Brazil. Conclusions: The previous analysis as foreseen in Brazilian regulation is important for the maintenance of RT quality offered to the national market.