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Clinical Trial
. 2018 Jun 25;113(8):e170433.
doi: 10.1590/0074-02760170433.

Validation and reliability of the rapid diagnostic test 'SD Bioeasy Dengue Duo' for dengue diagnosis in Brazil: a phase III study

Paulo Sousa Prado  1   2 , José Teófilo Duarte Almeida Júnior  1 , Lanna Takada de Abreu  1 , Cristina Gabriel Silva  2 , Larissa da Costa Souza  2 , Marizoneide Cavalcante Gomes  2 , Lucinda Malheiros Teixeira Mendes  2 , Eliane Maria Dos Santos  2 , Gustavo Adolfo Sierra Romero  1
Affiliations
Clinical Trial

Validation and reliability of the rapid diagnostic test 'SD Bioeasy Dengue Duo' for dengue diagnosis in Brazil: a phase III study

Paulo Sousa Prado et al. Mem Inst Oswaldo Cruz. .

Abstract

Background: The diagnosis of dengue is complex. Until recently, only specialised laboratories were able to confirm dengue infection. However, this has changed with the newly available immunochromatographic rapid tests. Early diagnosis is of great interest, and point-of-care rapid tests have been increasingly used in Brazil. Most of those tests have not undergone validation in the Brazilian population. In this context, we decided to evaluate a rapid test introduced in the Federal District (FD).

Objectives: To estimate the accuracy and reliability of the SD Bioeasy Dengue Duo rapid test and its components to detect dengue infections in a consecutive sample of symptomatic residents in the FD, Brazil.

Methods: In total, 1353 venous blood samples were collected between 2013 and 2014. Two hundred and six positive samples (cases) and 246 negative samples (non cases) were required for sensitivity and specificity estimation, respectively; for agreement evaluation, we used 401 samples. The reference standard used was a composite of MAC-ELISA, virus isolation and real-time polymerase chain reaction (RT-qPCR). The evaluation was conducted prospectively under field conditions in the public health units of the FD.

Findings: The results for the overall accuracy of the rapid test (NS1/IgM combined) showed 76% sensitivity and 98% specificity. The sensitivity for the NS1 component (67%) was better than that for the IgM component (35%). The positive likelihood ratio was 46, and the negative likelihood ratio was 0.24. The reliability of the test (NS1/IgM combined) demonstrated crude agreement of 98% (Kappa index 0.94).

Main conclusions: The present phase III, large-scale validation study demonstrates that the rapid test SD Bioeasy Dengue Duo has moderate sensitivity (NS1/IgM combined) and high specificity. Therefore, the test is useful in confirming the diagnosis of dengue, but not enough to rule out the diagnosis. Our results also suggest that Dengue virus (DENV) viral load estimated through the RT-qPCR and antibody level measured through the MAC-ELISA could have had a direct influence on the accuracy of the rapid test.

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Figures

Fig. 1
Fig. 1. flow diagram for the study of the accuracy of the SD Bioeasy Dengue Duo rapid test. Federal District (FD), Brazil, 2014.
Fig. 2
Fig. 2. sensitivity evaluation of the NS1 component, IgM component and the combination of both NS1 and IgM components of the SD Bioeasy Dengue Duo test according to the time from onset of symptoms to collection of the serum sample. Federal District (FD), Brazil, 2014.
Fig. 3
Fig. 3. sensitivity evaluation of the NS1 component, IgM component and the combination of both NS1 and IgM components of the SD Bioeasy Dengue Duo test according to the absorbance intensity of the reference standard test MAC-ELISA-IgM. Federal District (FD), Brazil, 2014.
Fig. 4
Fig. 4. sensitivity evaluation of the NS1 component, IgM component and the combination of both NS1 and IgM components of the SD Bioeasy Dengue Duo test according to the Ct of the reference pattern real-time polymerase chain reaction (RT-qPCR). Federal District (FD), Brazil, 2014.
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