Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.

The live attenuated tetravalent CYD-TDV vaccine (Dengvaxia) is effective but has scarcely been used due to safety concerns among seronegative recipients. Rapid diagnostic tests (RDTs) which can accurately determine individual dengue serostatus are needed for use in pre-vaccination screening. This st...

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Main Authors: Paul Arkell, Maria Tanesi, Nelia Gomes, Josefina C Joao, Tessa Oakley, Frederico Bosco, Jennifer Yan, Nicholas S S Fancourt, Joshua R Francis
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-11-01
Series:PLoS Neglected Tropical Diseases
Online Access:https://doi.org/10.1371/journal.pntd.0010877
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author Paul Arkell
Maria Tanesi
Nelia Gomes
Josefina C Joao
Tessa Oakley
Frederico Bosco
Jennifer Yan
Nicholas S S Fancourt
Joshua R Francis
author_facet Paul Arkell
Maria Tanesi
Nelia Gomes
Josefina C Joao
Tessa Oakley
Frederico Bosco
Jennifer Yan
Nicholas S S Fancourt
Joshua R Francis
author_sort Paul Arkell
collection DOAJ
description The live attenuated tetravalent CYD-TDV vaccine (Dengvaxia) is effective but has scarcely been used due to safety concerns among seronegative recipients. Rapid diagnostic tests (RDTs) which can accurately determine individual dengue serostatus are needed for use in pre-vaccination screening. This study aimed to determine the performance of existing RDTs (which have been designed to detect levels of immunoglobulin G, IgG, associated with acute post-primary dengue) when repurposed for detection of previous dengue infection (where concentrations of IgG are typically lower). A convenience sample of four-hundred-and-six participants including 217 children were recruited during a community serosurvey. Whole blood was collected by phlebotomy and tested using Bioline Dengue IgG/IgM (Abbott) and Standard Q Dengue IgM/IgG (SD Biosensor) RDTs in the field. Serum samples from the same individuals were also tested at National Health Laboratory. The Panbio indirect IgG ELISA was used as a reference test. Reference testing determined that 370 (91.1%) participants were dengue IgG seropositive. Both assays were highly specific (100.0%) but had low sensitivity (Bioline = 21.1% and Standard Q = 4.6%) when used in the field. Sensitivity was improved when RDTs were used under laboratory conditions, and when assays were allowed to run beyond manufacturer recommendations and read at a delayed time-point, but specificity was reduced. Efforts to develop RDTs with high sensitivity and specificity for prior dengue infection which can be operationalised for pre-vaccination screening are ongoing. Performance of forthcoming candidate assays should be tested under field conditions with blood samples, as well as in the laboratory.
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spelling doaj.art-76c291fffcc942108820b307faf7b9022022-12-22T04:41:18ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352022-11-011611e001087710.1371/journal.pntd.0010877Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.Paul ArkellMaria TanesiNelia GomesJosefina C JoaoTessa OakleyFrederico BoscoJennifer YanNicholas S S FancourtJoshua R FrancisThe live attenuated tetravalent CYD-TDV vaccine (Dengvaxia) is effective but has scarcely been used due to safety concerns among seronegative recipients. Rapid diagnostic tests (RDTs) which can accurately determine individual dengue serostatus are needed for use in pre-vaccination screening. This study aimed to determine the performance of existing RDTs (which have been designed to detect levels of immunoglobulin G, IgG, associated with acute post-primary dengue) when repurposed for detection of previous dengue infection (where concentrations of IgG are typically lower). A convenience sample of four-hundred-and-six participants including 217 children were recruited during a community serosurvey. Whole blood was collected by phlebotomy and tested using Bioline Dengue IgG/IgM (Abbott) and Standard Q Dengue IgM/IgG (SD Biosensor) RDTs in the field. Serum samples from the same individuals were also tested at National Health Laboratory. The Panbio indirect IgG ELISA was used as a reference test. Reference testing determined that 370 (91.1%) participants were dengue IgG seropositive. Both assays were highly specific (100.0%) but had low sensitivity (Bioline = 21.1% and Standard Q = 4.6%) when used in the field. Sensitivity was improved when RDTs were used under laboratory conditions, and when assays were allowed to run beyond manufacturer recommendations and read at a delayed time-point, but specificity was reduced. Efforts to develop RDTs with high sensitivity and specificity for prior dengue infection which can be operationalised for pre-vaccination screening are ongoing. Performance of forthcoming candidate assays should be tested under field conditions with blood samples, as well as in the laboratory.https://doi.org/10.1371/journal.pntd.0010877
spellingShingle Paul Arkell
Maria Tanesi
Nelia Gomes
Josefina C Joao
Tessa Oakley
Frederico Bosco
Jennifer Yan
Nicholas S S Fancourt
Joshua R Francis
Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.
PLoS Neglected Tropical Diseases
title Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.
title_full Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.
title_fullStr Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.
title_full_unstemmed Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.
title_short Field evaluation of rapid diagnostic tests to determine dengue serostatus in Timor-Leste.
title_sort field evaluation of rapid diagnostic tests to determine dengue serostatus in timor leste
url https://doi.org/10.1371/journal.pntd.0010877
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