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

Abstract

BACKGROUNDThe 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).OBJECTIVESTo 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.METHODSIn 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.FINDINGSThe 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 CONCLUSIONSThe 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.

Accuracy of the SD BIOLINE Dengue Duo for rapid point-of-care diagnosis of dengue

“…Previous evaluations of this RDT found much greater sensitivities, ranging between 75.5–97.5% [5–8,16–20]. The diversity in patients’ clinical characteristics, frequency of primary and secondary infections, infecting DENV serotypes, and reference dengue diagnostic methods used between our study and other investigations may explain the observed differences in the measured sensitivities [15,16,21].…”

Potential neuroprotective and anti-inflammatory effects provided by omega-3 (DHA) against Zika virus infection in human SH-SY5Y cells

“…al. 48 ) was made by High Pure Viral Nucleic Acid Version 18 Kit (Roche Diagnosis), with a single step reaction provided by LightCycler Multiplex RNA Virus Master Version 03 (Roche Diagnosis). RNA standards, in a final volume of 20 µl, were reverse transcribed; Primer concentration was 0.5 µM and probe was used in a concentration of 200 nM.…”

Evaluation of novel rapid detection kits for dengue virus NS1 antigen in Dhaka, Bangladesh, in 2017

“…Such pre-existing antibodies would compete with the monoclonal antibodies (MAbs) of RDTs [29] and interfere with the reaction monitored by RDTs. RDT signals upon secondary infection usually are weaker than those detected upon primary infection [14, 15, 20, 23, 25, 26, 30, 31]. Therefore, it would be desirable to have more-sensitive and less-cross-reactive antigen-detecting RDTs for accurate DENV diagnosis.…”