Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection
Abstract Background In September 2018, the World Health Organization recommended that prevaccination screening be used with the tetravalent dengue vaccine (CYD-TDV), to ensure that only individuals with evidence of prior dengue infection (PDI) are vaccinated. Dengue rapid diagnostic tests (RDTs) wou...
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| creator | Bonaparte, Matthew Zheng, Lingyi Garg, Sanjay Guy, Bruno Lustig, Yaniv Schwartz, Eli DiazGranados, Carlos A Savarino, Stephen Ataman-Önal, Yasemin |
| description | Abstract
Background
In September 2018, the World Health Organization recommended that prevaccination screening be used with the tetravalent dengue vaccine (CYD-TDV), to ensure that only individuals with evidence of prior dengue infection (PDI) are vaccinated. Dengue rapid diagnostic tests (RDTs) would offer a potential solution for prevaccination screening at the point-of-care, but data on performance of available RDTs for identifying PDI are limited. We determined the suitability of four dengue RDTs and two conventional enzyme-linked immunosorbent assays (ELISAs) to identify PDI and evaluated cross-reactivity with co-circulating flaviviruses.
Methods: Specificity was assessed using 534 dengue-negative [determined by 50% plaque reduction neutralization test (PRNT50)] serum samples from USA (n = 229) and dengue-endemic regions (n = 305). Sensitivity was assessed using 270 samples from recent (n = 90) or remote (n = 90) virologically confirmed prior dengue cases, and dengue PRNT50-positive samples (n = 90). Cross-reactivity was assessed in dengue-seronegative samples that were seropositive for yellow fever (n = 57), Japanese encephalitis (n = 37), West Nile (n = 59) or Zika (n = 41).
Results: Dengue IgG RDTs and the Panbio ELISA exhibited favourable specificities (99–100%), higher than the Focus ELISA (95%). The RDTs had variable sensitivities (40–70%) that were lower than those of the ELISAs (≥90%). Cross-reactivity to other flaviviruses was low with RDTs (≤7%), but more significant with ELISAs (up to 51% for West Nile and 34% for Zika). No cross-reactivity to any of the four closely related flaviviruses was observed with the CTK Biotech RDT. For each SeroTest, sensitivity appeared similar in samples from individuals with recent ( |
| doi_str_mv | 10.1093/jtm/taz078 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2306215810</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/jtm/taz078</oup_id><sourcerecordid>2306215810</sourcerecordid><originalsourceid>FETCH-LOGICAL-c345t-e977e9f95276ce51b966d62dfeda5a70af16f2d3c135e1083a5f06b4e8ecceb43</originalsourceid><addsrcrecordid>eNp90U1rFTEYBeAgiq3VjT9AAiKIMDYfk0yyLKV-QMGNrodM8qbkdia5TTIXbumPN5fbuujCVd7Aw4HDQeg9JV8p0fx8U5fzau7JoF6gUzoQ1SlOxMt2Uy06qhU7QW9K2RBCmGLsNTrhVFKpe32KHq52Zl5NDSni5HE22-CwC-YmplKDxRVKLdhEh22KO4gHaGYM8X6_QDeHeAsOh2VZm095agCbUsy-4Jqwgwp5CRHwNoeU2z_erIBD9GAPQW_RK2_mAu8e3zP059vV78sf3fWv7z8vL647y3tRO9DDANprwQZpQdBJS-kkcx6cEWYgxlPpmeOWcgGUKG6EJ3LqQYG1MPX8DH0-5m5zultbo3EJxcI8mwhpLSPjRDIqFCWNfnxGN2nNrXJTPel7qrSkTX05KptTKRn82AouJu9HSsbDJmPbZDxu0vCHx8h1WsD9o08jNPDpCNK6_V_QXzpTmGg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2404418961</pqid></control><display><type>article</type><title>Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Alma/SFX Local Collection</source><creator>Bonaparte, Matthew ; Zheng, Lingyi ; Garg, Sanjay ; Guy, Bruno ; Lustig, Yaniv ; Schwartz, Eli ; DiazGranados, Carlos A ; Savarino, Stephen ; Ataman-Önal, Yasemin</creator><creatorcontrib>Bonaparte, Matthew ; Zheng, Lingyi ; Garg, Sanjay ; Guy, Bruno ; Lustig, Yaniv ; Schwartz, Eli ; DiazGranados, Carlos A ; Savarino, Stephen ; Ataman-Önal, Yasemin</creatorcontrib><description>Abstract
Background
In September 2018, the World Health Organization recommended that prevaccination screening be used with the tetravalent dengue vaccine (CYD-TDV), to ensure that only individuals with evidence of prior dengue infection (PDI) are vaccinated. Dengue rapid diagnostic tests (RDTs) would offer a potential solution for prevaccination screening at the point-of-care, but data on performance of available RDTs for identifying PDI are limited. We determined the suitability of four dengue RDTs and two conventional enzyme-linked immunosorbent assays (ELISAs) to identify PDI and evaluated cross-reactivity with co-circulating flaviviruses.
Methods: Specificity was assessed using 534 dengue-negative [determined by 50% plaque reduction neutralization test (PRNT50)] serum samples from USA (n = 229) and dengue-endemic regions (n = 305). Sensitivity was assessed using 270 samples from recent (n = 90) or remote (n = 90) virologically confirmed prior dengue cases, and dengue PRNT50-positive samples (n = 90). Cross-reactivity was assessed in dengue-seronegative samples that were seropositive for yellow fever (n = 57), Japanese encephalitis (n = 37), West Nile (n = 59) or Zika (n = 41).
Results: Dengue IgG RDTs and the Panbio ELISA exhibited favourable specificities (99–100%), higher than the Focus ELISA (95%). The RDTs had variable sensitivities (40–70%) that were lower than those of the ELISAs (≥90%). Cross-reactivity to other flaviviruses was low with RDTs (≤7%), but more significant with ELISAs (up to 51% for West Nile and 34% for Zika). No cross-reactivity to any of the four closely related flaviviruses was observed with the CTK Biotech RDT. For each SeroTest, sensitivity appeared similar in samples from individuals with recent (<13 months) vs remote (3–4 years) virologically confirmed PDI.
Conclusions: In general, dengue IgG RDTs were found to be more specific and less cross-reactive than the ELISAs, but the latter were more sensitive for identifying PDI cases. Currently available RDTs could be temporizing tools for rapid and safe prevaccination screening until improved RDTs with increased sensitivity become available.</description><identifier>ISSN: 1195-1982</identifier><identifier>EISSN: 1708-8305</identifier><identifier>DOI: 10.1093/jtm/taz078</identifier><identifier>PMID: 31616949</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Cross-reactivity ; Dengue fever ; Diagnostic systems ; Diagnostic tests ; Encephalitis ; Enzyme-linked immunosorbent assay ; Enzymes ; Flaviviridae ; Immunoassays ; Immunoglobulin G ; Infections ; Medical diagnosis ; Neutralization ; Reactivity ; Screening ; Sensitivity analysis ; Vaccines ; Vector-borne diseases ; Yellow fever</subject><ispartof>Journal of travel medicine, 2019-12, Vol.26 (8)</ispartof><rights>International Society of Travel Medicine 2019. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com. 2019</rights><rights>International Society of Travel Medicine 2019. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c345t-e977e9f95276ce51b966d62dfeda5a70af16f2d3c135e1083a5f06b4e8ecceb43</citedby><cites>FETCH-LOGICAL-c345t-e977e9f95276ce51b966d62dfeda5a70af16f2d3c135e1083a5f06b4e8ecceb43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1578,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31616949$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bonaparte, Matthew</creatorcontrib><creatorcontrib>Zheng, Lingyi</creatorcontrib><creatorcontrib>Garg, Sanjay</creatorcontrib><creatorcontrib>Guy, Bruno</creatorcontrib><creatorcontrib>Lustig, Yaniv</creatorcontrib><creatorcontrib>Schwartz, Eli</creatorcontrib><creatorcontrib>DiazGranados, Carlos A</creatorcontrib><creatorcontrib>Savarino, Stephen</creatorcontrib><creatorcontrib>Ataman-Önal, Yasemin</creatorcontrib><title>Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection</title><title>Journal of travel medicine</title><addtitle>J Travel Med</addtitle><description>Abstract
Background
In September 2018, the World Health Organization recommended that prevaccination screening be used with the tetravalent dengue vaccine (CYD-TDV), to ensure that only individuals with evidence of prior dengue infection (PDI) are vaccinated. Dengue rapid diagnostic tests (RDTs) would offer a potential solution for prevaccination screening at the point-of-care, but data on performance of available RDTs for identifying PDI are limited. We determined the suitability of four dengue RDTs and two conventional enzyme-linked immunosorbent assays (ELISAs) to identify PDI and evaluated cross-reactivity with co-circulating flaviviruses.
Methods: Specificity was assessed using 534 dengue-negative [determined by 50% plaque reduction neutralization test (PRNT50)] serum samples from USA (n = 229) and dengue-endemic regions (n = 305). Sensitivity was assessed using 270 samples from recent (n = 90) or remote (n = 90) virologically confirmed prior dengue cases, and dengue PRNT50-positive samples (n = 90). Cross-reactivity was assessed in dengue-seronegative samples that were seropositive for yellow fever (n = 57), Japanese encephalitis (n = 37), West Nile (n = 59) or Zika (n = 41).
Results: Dengue IgG RDTs and the Panbio ELISA exhibited favourable specificities (99–100%), higher than the Focus ELISA (95%). The RDTs had variable sensitivities (40–70%) that were lower than those of the ELISAs (≥90%). Cross-reactivity to other flaviviruses was low with RDTs (≤7%), but more significant with ELISAs (up to 51% for West Nile and 34% for Zika). No cross-reactivity to any of the four closely related flaviviruses was observed with the CTK Biotech RDT. For each SeroTest, sensitivity appeared similar in samples from individuals with recent (<13 months) vs remote (3–4 years) virologically confirmed PDI.
Conclusions: In general, dengue IgG RDTs were found to be more specific and less cross-reactive than the ELISAs, but the latter were more sensitive for identifying PDI cases. Currently available RDTs could be temporizing tools for rapid and safe prevaccination screening until improved RDTs with increased sensitivity become available.</description><subject>Cross-reactivity</subject><subject>Dengue fever</subject><subject>Diagnostic systems</subject><subject>Diagnostic tests</subject><subject>Encephalitis</subject><subject>Enzyme-linked immunosorbent assay</subject><subject>Enzymes</subject><subject>Flaviviridae</subject><subject>Immunoassays</subject><subject>Immunoglobulin G</subject><subject>Infections</subject><subject>Medical diagnosis</subject><subject>Neutralization</subject><subject>Reactivity</subject><subject>Screening</subject><subject>Sensitivity analysis</subject><subject>Vaccines</subject><subject>Vector-borne diseases</subject><subject>Yellow fever</subject><issn>1195-1982</issn><issn>1708-8305</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp90U1rFTEYBeAgiq3VjT9AAiKIMDYfk0yyLKV-QMGNrodM8qbkdia5TTIXbumPN5fbuujCVd7Aw4HDQeg9JV8p0fx8U5fzau7JoF6gUzoQ1SlOxMt2Uy06qhU7QW9K2RBCmGLsNTrhVFKpe32KHq52Zl5NDSni5HE22-CwC-YmplKDxRVKLdhEh22KO4gHaGYM8X6_QDeHeAsOh2VZm095agCbUsy-4Jqwgwp5CRHwNoeU2z_erIBD9GAPQW_RK2_mAu8e3zP059vV78sf3fWv7z8vL647y3tRO9DDANprwQZpQdBJS-kkcx6cEWYgxlPpmeOWcgGUKG6EJ3LqQYG1MPX8DH0-5m5zultbo3EJxcI8mwhpLSPjRDIqFCWNfnxGN2nNrXJTPel7qrSkTX05KptTKRn82AouJu9HSsbDJmPbZDxu0vCHx8h1WsD9o08jNPDpCNK6_V_QXzpTmGg</recordid><startdate>20191223</startdate><enddate>20191223</enddate><creator>Bonaparte, Matthew</creator><creator>Zheng, Lingyi</creator><creator>Garg, Sanjay</creator><creator>Guy, Bruno</creator><creator>Lustig, Yaniv</creator><creator>Schwartz, Eli</creator><creator>DiazGranados, Carlos A</creator><creator>Savarino, Stephen</creator><creator>Ataman-Önal, Yasemin</creator><general>Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FQ</scope><scope>8FV</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M3G</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20191223</creationdate><title>Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection</title><author>Bonaparte, Matthew ; Zheng, Lingyi ; Garg, Sanjay ; Guy, Bruno ; Lustig, Yaniv ; Schwartz, Eli ; DiazGranados, Carlos A ; Savarino, Stephen ; Ataman-Önal, Yasemin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c345t-e977e9f95276ce51b966d62dfeda5a70af16f2d3c135e1083a5f06b4e8ecceb43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Cross-reactivity</topic><topic>Dengue fever</topic><topic>Diagnostic systems</topic><topic>Diagnostic tests</topic><topic>Encephalitis</topic><topic>Enzyme-linked immunosorbent assay</topic><topic>Enzymes</topic><topic>Flaviviridae</topic><topic>Immunoassays</topic><topic>Immunoglobulin G</topic><topic>Infections</topic><topic>Medical diagnosis</topic><topic>Neutralization</topic><topic>Reactivity</topic><topic>Screening</topic><topic>Sensitivity analysis</topic><topic>Vaccines</topic><topic>Vector-borne diseases</topic><topic>Yellow fever</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bonaparte, Matthew</creatorcontrib><creatorcontrib>Zheng, Lingyi</creatorcontrib><creatorcontrib>Garg, Sanjay</creatorcontrib><creatorcontrib>Guy, Bruno</creatorcontrib><creatorcontrib>Lustig, Yaniv</creatorcontrib><creatorcontrib>Schwartz, Eli</creatorcontrib><creatorcontrib>DiazGranados, Carlos A</creatorcontrib><creatorcontrib>Savarino, Stephen</creatorcontrib><creatorcontrib>Ataman-Önal, Yasemin</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Canadian Business & Current Affairs Database</collection><collection>Canadian Business & Current Affairs Database (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>CBCA Reference & Current Events</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of travel medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bonaparte, Matthew</au><au>Zheng, Lingyi</au><au>Garg, Sanjay</au><au>Guy, Bruno</au><au>Lustig, Yaniv</au><au>Schwartz, Eli</au><au>DiazGranados, Carlos A</au><au>Savarino, Stephen</au><au>Ataman-Önal, Yasemin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection</atitle><jtitle>Journal of travel medicine</jtitle><addtitle>J Travel Med</addtitle><date>2019-12-23</date><risdate>2019</risdate><volume>26</volume><issue>8</issue><issn>1195-1982</issn><eissn>1708-8305</eissn><abstract>Abstract
Background
In September 2018, the World Health Organization recommended that prevaccination screening be used with the tetravalent dengue vaccine (CYD-TDV), to ensure that only individuals with evidence of prior dengue infection (PDI) are vaccinated. Dengue rapid diagnostic tests (RDTs) would offer a potential solution for prevaccination screening at the point-of-care, but data on performance of available RDTs for identifying PDI are limited. We determined the suitability of four dengue RDTs and two conventional enzyme-linked immunosorbent assays (ELISAs) to identify PDI and evaluated cross-reactivity with co-circulating flaviviruses.
Methods: Specificity was assessed using 534 dengue-negative [determined by 50% plaque reduction neutralization test (PRNT50)] serum samples from USA (n = 229) and dengue-endemic regions (n = 305). Sensitivity was assessed using 270 samples from recent (n = 90) or remote (n = 90) virologically confirmed prior dengue cases, and dengue PRNT50-positive samples (n = 90). Cross-reactivity was assessed in dengue-seronegative samples that were seropositive for yellow fever (n = 57), Japanese encephalitis (n = 37), West Nile (n = 59) or Zika (n = 41).
Results: Dengue IgG RDTs and the Panbio ELISA exhibited favourable specificities (99–100%), higher than the Focus ELISA (95%). The RDTs had variable sensitivities (40–70%) that were lower than those of the ELISAs (≥90%). Cross-reactivity to other flaviviruses was low with RDTs (≤7%), but more significant with ELISAs (up to 51% for West Nile and 34% for Zika). No cross-reactivity to any of the four closely related flaviviruses was observed with the CTK Biotech RDT. For each SeroTest, sensitivity appeared similar in samples from individuals with recent (<13 months) vs remote (3–4 years) virologically confirmed PDI.
Conclusions: In general, dengue IgG RDTs were found to be more specific and less cross-reactive than the ELISAs, but the latter were more sensitive for identifying PDI cases. Currently available RDTs could be temporizing tools for rapid and safe prevaccination screening until improved RDTs with increased sensitivity become available.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>31616949</pmid><doi>10.1093/jtm/taz078</doi></addata></record> |
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| subjects | Cross-reactivity Dengue fever Diagnostic systems Diagnostic tests Encephalitis Enzyme-linked immunosorbent assay Enzymes Flaviviridae Immunoassays Immunoglobulin G Infections Medical diagnosis Neutralization Reactivity Screening Sensitivity analysis Vaccines Vector-borne diseases Yellow fever |
| title | Evaluation of rapid diagnostic tests and conventional enzyme-linked immunosorbent assays to determine prior dengue infection |
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