Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.

<h4>Background</h4>Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combin...

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Main Authors: Anne-Claire Andries, Veasna Duong, Chantha Ngan, Sivuth Ong, Rekol Huy, Kim Kim Sroin, Vantha Te, Bunthin Y, Patrich Lorn Try, Philippe Buchy
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2012-01-01
Series:PLoS Neglected Tropical Diseases
Online Access:https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0001993&type=printable
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author Anne-Claire Andries
Veasna Duong
Chantha Ngan
Sivuth Ong
Rekol Huy
Kim Kim Sroin
Vantha Te
Bunthin Y
Patrich Lorn Try
Philippe Buchy
author_facet Anne-Claire Andries
Veasna Duong
Chantha Ngan
Sivuth Ong
Rekol Huy
Kim Kim Sroin
Vantha Te
Bunthin Y
Patrich Lorn Try
Philippe Buchy
author_sort Anne-Claire Andries
collection DOAJ
description <h4>Background</h4>Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.<h4>Methodology/principal findings</h4>During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.<h4>Conclusions</h4>In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.
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spelling doaj.art-82a463a96e6e483fbdcf2f0a02c5ce132025-02-21T05:43:02ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352012-01-01612e199310.1371/journal.pntd.0001993Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.Anne-Claire AndriesVeasna DuongChantha NganSivuth OngRekol HuyKim Kim SroinVantha TeBunthin YPatrich Lorn TryPhilippe Buchy<h4>Background</h4>Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.<h4>Methodology/principal findings</h4>During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.<h4>Conclusions</h4>In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0001993&type=printable
spellingShingle Anne-Claire Andries
Veasna Duong
Chantha Ngan
Sivuth Ong
Rekol Huy
Kim Kim Sroin
Vantha Te
Bunthin Y
Patrich Lorn Try
Philippe Buchy
Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
PLoS Neglected Tropical Diseases
title Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
title_full Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
title_fullStr Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
title_full_unstemmed Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
title_short Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG.
title_sort field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue ns1 igm and igg
url https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0001993&type=printable
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