Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever

Subhamoy Pal, Allison L. Dauner, Andrea Valks, Brett M. Forshey, Kanya C. Long, Butsaya Thaisomboonsuk, Gloria Sierra, Victor Picos, Sara Talmage, Amy C. Morrison, Eric S. Halsey, Guillermo Comach, Chadwick Yasuda, Michael Loeffelholz, Richard G. Jarman, Stefan Fernandez, Ung Sam An, Tadeusz J. Kochel, Louis E. Jasper, Shuenn Jue L Wu

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

Original languageEnglish (US)
Pages (from-to)1092-1102
Number of pages11
JournalJournal of Clinical Microbiology
Volume53
Issue number4
DOIs
StatePublished - Apr 1 2015

Fingerprint

Dengue
Routine Diagnostic Tests
Enzyme-Linked Immunosorbent Assay
Immunoglobulin M
Immunoglobulin G
Fever
Confidence Intervals
Cambodia
Neutralization Tests
Equipment and Supplies
Venezuela
Peru
Thailand
Coinfection
Multicenter Studies
Disease Outbreaks
Patient Care
Prospective Studies
Viruses
Sensitivity and Specificity

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever. / Pal, Subhamoy; Dauner, Allison L.; Valks, Andrea; Forshey, Brett M.; Long, Kanya C.; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C.; Halsey, Eric S.; Comach, Guillermo; Yasuda, Chadwick; Loeffelholz, Michael; Jarman, Richard G.; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J.; Jasper, Louis E.; Wu, Shuenn Jue L.

In: Journal of Clinical Microbiology, Vol. 53, No. 4, 01.04.2015, p. 1092-1102.

Research output: Contribution to journalArticle

Pal, S, Dauner, AL, Valks, A, Forshey, BM, Long, KC, Thaisomboonsuk, B, Sierra, G, Picos, V, Talmage, S, Morrison, AC, Halsey, ES, Comach, G, Yasuda, C, Loeffelholz, M, Jarman, RG, Fernandez, S, An, US, Kochel, TJ, Jasper, LE & Wu, SJL 2015, 'Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever', Journal of Clinical Microbiology, vol. 53, no. 4, pp. 1092-1102. https://doi.org/10.1128/JCM.03042-14
Pal, Subhamoy ; Dauner, Allison L. ; Valks, Andrea ; Forshey, Brett M. ; Long, Kanya C. ; Thaisomboonsuk, Butsaya ; Sierra, Gloria ; Picos, Victor ; Talmage, Sara ; Morrison, Amy C. ; Halsey, Eric S. ; Comach, Guillermo ; Yasuda, Chadwick ; Loeffelholz, Michael ; Jarman, Richard G. ; Fernandez, Stefan ; An, Ung Sam ; Kochel, Tadeusz J. ; Jasper, Louis E. ; Wu, Shuenn Jue L. / Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever. In: Journal of Clinical Microbiology. 2015 ; Vol. 53, No. 4. pp. 1092-1102.
@article{d340d5d34fda45e98efbd91cc02cebc8,
title = "Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever",
abstract = "We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3{\%} (95{\%} confidence interval [CI], 84.1 to 90.2{\%}) and specificity of 86.8{\%} (95{\%} CI, 83.9 to 89.3{\%}) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1{\%} (87.8 to 95.2{\%}) and specificity of 62.2{\%} (54.5 to 69.5{\%}) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6{\%} (82.7 to 91.4{\%}) and specificity of 88.1{\%} (82.2 to 92.6{\%}) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6{\%} (62.1 to 76.4{\%}) and a specificity of 88.4{\%} (82.6 to 92.8{\%}) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.",
author = "Subhamoy Pal and Dauner, {Allison L.} and Andrea Valks and Forshey, {Brett M.} and Long, {Kanya C.} and Butsaya Thaisomboonsuk and Gloria Sierra and Victor Picos and Sara Talmage and Morrison, {Amy C.} and Halsey, {Eric S.} and Guillermo Comach and Chadwick Yasuda and Michael Loeffelholz and Jarman, {Richard G.} and Stefan Fernandez and An, {Ung Sam} and Kochel, {Tadeusz J.} and Jasper, {Louis E.} and Wu, {Shuenn Jue L}",
year = "2015",
month = "4",
day = "1",
doi = "10.1128/JCM.03042-14",
language = "English (US)",
volume = "53",
pages = "1092--1102",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "4",

}

TY - JOUR

T1 - Multicountry prospective clinical evaluation of two enzyme-linked immunosorbent assays and two rapid diagnostic tests for diagnosing dengue fever

AU - Pal, Subhamoy

AU - Dauner, Allison L.

AU - Valks, Andrea

AU - Forshey, Brett M.

AU - Long, Kanya C.

AU - Thaisomboonsuk, Butsaya

AU - Sierra, Gloria

AU - Picos, Victor

AU - Talmage, Sara

AU - Morrison, Amy C.

AU - Halsey, Eric S.

AU - Comach, Guillermo

AU - Yasuda, Chadwick

AU - Loeffelholz, Michael

AU - Jarman, Richard G.

AU - Fernandez, Stefan

AU - An, Ung Sam

AU - Kochel, Tadeusz J.

AU - Jasper, Louis E.

AU - Wu, Shuenn Jue L

PY - 2015/4/1

Y1 - 2015/4/1

N2 - We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

AB - We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

UR - http://www.scopus.com/inward/record.url?scp=84925238976&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84925238976&partnerID=8YFLogxK

U2 - 10.1128/JCM.03042-14

DO - 10.1128/JCM.03042-14

M3 - Article

VL - 53

SP - 1092

EP - 1102

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

SN - 0095-1137

IS - 4

ER -