Evidence map›Paper›PMID 29947711›Full record

Trial reportMemorias do Instituto Oswaldo Cruz2018

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

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

Open access · diamondAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Memorias do Instituto Oswaldo Cruz, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Diagnostic performance of the bioline dengue duo rapid test on symptomatic patients assisted at Armed Forces Hospital (Hfa) in Brasília, Brazil.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2024
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Paulo Sousa PradoUniversidade de Brasília, Núcleo de Medicina Tropical, Brasília, DF, Brasil.
José Teófilo Duarte Almeida JúniorUniversidade de Brasília, Núcleo de Medicina Tropical, Brasília, DF, Brasil.
Lanna Takada de AbreuUniversidade de Brasília, Núcleo de Medicina Tropical, Brasília, DF, Brasil.
Cristina Gabriel SilvaLaboratório Central de Saúde Pública, Brasília, DF, Brasil.
Larissa da Costa SouzaLaboratório Central de Saúde Pública, Brasília, DF, Brasil.
Marizoneide Cavalcante GomesLaboratório Central de Saúde Pública, Brasília, DF, Brasil.
Lucinda Malheiros Teixeira MendesLaboratório Central de Saúde Pública, Brasília, DF, Brasil.
Eliane Maria Dos SantosLaboratório Central de Saúde Pública, Brasília, DF, Brasil.
Gustavo Adolfo Sierra RomeroUniversidade de Brasília, Núcleo de Medicina Tropical, Brasília, DF, Brasil.
Universidade de Brasília · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Early DiagnosisAdolescentAdultAgedAged, 80 and overAntibodies, ViralBrazilChildChild, PreschoolDengueDengue VirusDiagnostic Tests, RoutineFemaleHumansImmunoglobulin MInfantAntibodies, ViralImmunoglobulin M

Identifiers

PMID29947711
PMCPMC6014722
OpenAlexW2810468755

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.