What question did this study set out to answer?

Assess the performance of rapid dengue tests for NS1 antigen and antibodies received by INCQS/Fiocruz in 2025.

May 9, 20260 citationsOpen Access

Quality assessment of rapid tests for serological diagnosis of dengue fever

MOMariana B. OliveiraUniversity of Aveiro CFCarolina Ferreira ÁRÁlvaro Ribeiro

Key Points

Assess the performance of rapid dengue tests for NS1 antigen and antibodies received by INCQS/Fiocruz in 2025.
Analyzed performance results of rapid tests received from January 1 to December 31, 2025.
Sensitivity and specificity values were compared to those declared in product instructions.
Included analysis of 56 batches with categorization based on detection type: Ag, Ab, and Ag/Ab.
Out of 56 batches, 48 (85.7%) were satisfactory and 8 (14.3%) were unsatisfactory.
NS1 detection effective for acute phase diagnosis, particularly within 5 days of symptom onset.
62.5% of unsatisfactory tests were Ag/Ab detection and 37.5% were Ab tests.

Abstract

Introduction:The dengue fever epidemic that occurred in Brazil in 2024 resulted in more than 6.5 million cases.The demand for high-performance, fast, and accessible tests highlights the challenges, in the context of Sanitary Surveillance, to offer the population adequate diagnosis and treatment, based on the quality of tests offered in the country.Rapid tests (RT) are simple and quick to perform, and do not require complex infrastructure.In this context, the National Institute for Quality Control in Health (INCQS/Fiocruz) analyzes in vitro dengue diagnostic devices as part of the registration process for these products with Anvisa (Brazilian Health Regulatory Agency).Objectives: Assess the performance of rapid dengue tests received by INCQS/Fiocruz between January 1 and December 31, 2025. Methodology:The performance results of batches of RTs for the detection of NS1 antigen (Ag), IgM/IgG antibodies (Ab), and dengue Ag/Ab, received in 2025, were analyzed using the HARPYA sample management system.The sensitivity and specificity values obtained in the analyses were compared to those declared in the product instructions for use.RTs with values equal to or higher than those declared were considered satisfactory, and those with lower values were considered unsatisfactory.Results: Of the 56 batches received, 23 (41.1%) corresponded to the detection of Ag, 18 (32.1%) of Ab, and 15 (26.8%) of Ag/Ab.Regarding origin, 13 (23.2%)were domestic and 43 (76.8%) were imported.A total of 48 (85.7%) batches showed satisfactory results and 8 (14.3%) unsatisfactory results.RTs for Ag/ Ab detection accounted for 5 (62.5%) and Ab RTs for 3 (37.5%) of the unsatisfactory tests.NS1 detection is effective for diagnosing the acute phase, especially up to 5 days after the onset of symptoms.After this period, false negative results may occur, especially in asymptomatic individuals, compromising early diagnosis and treatment.Therefore, all tests should be interpreted with caution, considering the clinical picture and the stage of infection. Conclusion:Maintaining the analysis of RTs contributes to the quality, safety, and efficacy of the devices, enabling accurate diagnosis and appropriate treatment, which are crucial for the effective implementation of prevention and control measures.

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