Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus
Dengue is an acute illness caused by the positive-strand RNA dengue virus (DENV). There are four genetically distinct DENVs (DENV-1-4) that cause disease in tropical and subtropical countries. Most patients are viremic when they present with symptoms; therefore, RT-PCR has been increasingly used in...
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| Veröffentlicht in: | PLoS neglected tropical diseases 2013-07, Vol.7 (7), p.e2311-e2311 |
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| creator | Santiago, Gilberto A Vergne, Edgardo Quiles, Yashira Cosme, Joan Vazquez, Jesus Medina, Juan F Medina, Freddy Colón, Candimar Margolis, Harold Muñoz-Jordán, Jorge L |
| description | Dengue is an acute illness caused by the positive-strand RNA dengue virus (DENV). There are four genetically distinct DENVs (DENV-1-4) that cause disease in tropical and subtropical countries. Most patients are viremic when they present with symptoms; therefore, RT-PCR has been increasingly used in dengue diagnosis. The CDC DENV-1-4 RT-PCR Assay has been developed as an in-vitro diagnostic platform and was recently approved by the US Food and Drug Administration (FDA) for detection of dengue in patients with signs or symptoms of mild or severe dengue. The primers and probes of this test have been designed to detect currently circulating strains of DENV-1-4 from around the world at comparable sensitivity. In a retrospective study with 102 dengue cases confirmed by IgM anti-DENV seroconversion in the convalescent sample, the RT-PCR Assay detected DENV RNA in 98.04% of the paired acute samples. Using sequencing as a positive indicator, the RT-PCR Assay had a 97.92% positive agreement in 86 suspected dengue patients with a single acute serum sample. After extensive validations, the RT-PCR Assay performance was highly reproducible when evaluated across three independent testing sites, did not produce false positive results for etiologic agents of other febrile illnesses, and was not affected by pathological levels of potentially interfering biomolecules. These results indicate that the CDC DENV-1-4 RT-PCR Assay provides a reliable diagnostic platform capable for confirming dengue in suspected cases. |
| doi_str_mv | 10.1371/journal.pntd.0002311 |
| format | Article |
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There are four genetically distinct DENVs (DENV-1-4) that cause disease in tropical and subtropical countries. Most patients are viremic when they present with symptoms; therefore, RT-PCR has been increasingly used in dengue diagnosis. The CDC DENV-1-4 RT-PCR Assay has been developed as an in-vitro diagnostic platform and was recently approved by the US Food and Drug Administration (FDA) for detection of dengue in patients with signs or symptoms of mild or severe dengue. The primers and probes of this test have been designed to detect currently circulating strains of DENV-1-4 from around the world at comparable sensitivity. In a retrospective study with 102 dengue cases confirmed by IgM anti-DENV seroconversion in the convalescent sample, the RT-PCR Assay detected DENV RNA in 98.04% of the paired acute samples. Using sequencing as a positive indicator, the RT-PCR Assay had a 97.92% positive agreement in 86 suspected dengue patients with a single acute serum sample. After extensive validations, the RT-PCR Assay performance was highly reproducible when evaluated across three independent testing sites, did not produce false positive results for etiologic agents of other febrile illnesses, and was not affected by pathological levels of potentially interfering biomolecules. These results indicate that the CDC DENV-1-4 RT-PCR Assay provides a reliable diagnostic platform capable for confirming dengue in suspected cases.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0002311</identifier><identifier>PMID: 23875046</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adolescent ; Centers for Disease Control and Prevention (U.S.) ; Dengue - diagnosis ; Dengue fever ; Dengue virus ; Dengue Virus - classification ; Dengue Virus - genetics ; Dengue Virus - isolation & purification ; FDA approval ; Gene amplification ; Genomes ; Humans ; Illnesses ; Laboratories ; Medicine ; Microbiology ; Molecular Diagnostic Techniques - methods ; Pain ; Real-Time Polymerase Chain Reaction - methods ; Reproducibility of Results ; Retrospective Studies ; Reverse Transcriptase Polymerase Chain Reaction - methods ; Sensitivity and Specificity ; Studies ; United States ; Virology - methods</subject><ispartof>PLoS neglected tropical diseases, 2013-07, Vol.7 (7), p.e2311-e2311</ispartof><rights>2013</rights><rights>2013 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Citation: Santiago GA, Vergne E, Quiles Y, Cosme J, Vazquez J, et al. (2013) Analytical and Clinical Performance of the CDC Real Time RT-PCR Assay for Detection and Typing of Dengue Virus. PLoS Negl Trop Dis 7(7): e2311. doi:10.1371/journal.pntd.0002311</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c597t-dcb8b12f7072a7e559e2cc7649955d58ad1707d7a34f35d40f7d0fa692504d7f3</citedby><cites>FETCH-LOGICAL-c597t-dcb8b12f7072a7e559e2cc7649955d58ad1707d7a34f35d40f7d0fa692504d7f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708876/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708876/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23875046$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santiago, Gilberto A</creatorcontrib><creatorcontrib>Vergne, Edgardo</creatorcontrib><creatorcontrib>Quiles, Yashira</creatorcontrib><creatorcontrib>Cosme, Joan</creatorcontrib><creatorcontrib>Vazquez, Jesus</creatorcontrib><creatorcontrib>Medina, Juan F</creatorcontrib><creatorcontrib>Medina, Freddy</creatorcontrib><creatorcontrib>Colón, Candimar</creatorcontrib><creatorcontrib>Margolis, Harold</creatorcontrib><creatorcontrib>Muñoz-Jordán, Jorge L</creatorcontrib><title>Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>Dengue is an acute illness caused by the positive-strand RNA dengue virus (DENV). 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After extensive validations, the RT-PCR Assay performance was highly reproducible when evaluated across three independent testing sites, did not produce false positive results for etiologic agents of other febrile illnesses, and was not affected by pathological levels of potentially interfering biomolecules. These results indicate that the CDC DENV-1-4 RT-PCR Assay provides a reliable diagnostic platform capable for confirming dengue in suspected cases.</description><subject>Adolescent</subject><subject>Centers for Disease Control and Prevention (U.S.)</subject><subject>Dengue - diagnosis</subject><subject>Dengue fever</subject><subject>Dengue virus</subject><subject>Dengue Virus - classification</subject><subject>Dengue Virus - genetics</subject><subject>Dengue Virus - isolation & purification</subject><subject>FDA approval</subject><subject>Gene amplification</subject><subject>Genomes</subject><subject>Humans</subject><subject>Illnesses</subject><subject>Laboratories</subject><subject>Medicine</subject><subject>Microbiology</subject><subject>Molecular Diagnostic Techniques - methods</subject><subject>Pain</subject><subject>Real-Time Polymerase Chain Reaction - methods</subject><subject>Reproducibility of Results</subject><subject>Retrospective Studies</subject><subject>Reverse Transcriptase Polymerase Chain Reaction - methods</subject><subject>Sensitivity and Specificity</subject><subject>Studies</subject><subject>United States</subject><subject>Virology - methods</subject><issn>1935-2735</issn><issn>1935-2727</issn><issn>1935-2735</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>DOA</sourceid><recordid>eNqNkstu1DAUhiMEou3AGyDwkk0GX-JLNkhVoFCpEqgqa8uxT6YZJfZgJ5Xm7fHMpFW7Y-XL-c93LvqL4gPBa8Ik-bINc_RmWO_85NYYY8oIeVWck5rxkkrGXz-7nxUXKW0x5jVX5G1xRpmSHFfivPCXmbGfemsGZLxDduj98bGD2IU4Gm8BhQ5N94Cabw2KkGNTPwK6vSt_N7fIpGT2KEuRgwns1Ad_BE37Xe83h1QHfjMDeujjnN4VbzozJHi_nKviz9X3u-ZnefPrx3VzeVNaXsupdLZVLaGdxJIaCZzXQK2Voqprzh1XxpEcctKwqmPcVbiTDndG1DRP5WTHVsWnE3c3hKSXVSVNKoalEhXmWXF9UrhgtnoX-9HEvQ6m18ePEDfaxLyXATRuGVjFgBraVdhKI5yQIBmtuGBtKzPr61JtbkdwFvwUzfAC-jLi-3u9CQ-aSayUFBnweQHE8HeGNOmxTxaGwXgI86HvWiilcsH_kBIiWEXzqKuiOkltDClF6J46IlgfPPS4GH3wkF48lNM-Pp_mKenRNOwfOHrFBA</recordid><startdate>20130711</startdate><enddate>20130711</enddate><creator>Santiago, Gilberto A</creator><creator>Vergne, Edgardo</creator><creator>Quiles, Yashira</creator><creator>Cosme, Joan</creator><creator>Vazquez, Jesus</creator><creator>Medina, Juan F</creator><creator>Medina, Freddy</creator><creator>Colón, Candimar</creator><creator>Margolis, Harold</creator><creator>Muñoz-Jordán, Jorge L</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T2</scope><scope>7U2</scope><scope>7U9</scope><scope>C1K</scope><scope>F1W</scope><scope>H94</scope><scope>H95</scope><scope>H97</scope><scope>L.G</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20130711</creationdate><title>Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus</title><author>Santiago, Gilberto A ; 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There are four genetically distinct DENVs (DENV-1-4) that cause disease in tropical and subtropical countries. Most patients are viremic when they present with symptoms; therefore, RT-PCR has been increasingly used in dengue diagnosis. The CDC DENV-1-4 RT-PCR Assay has been developed as an in-vitro diagnostic platform and was recently approved by the US Food and Drug Administration (FDA) for detection of dengue in patients with signs or symptoms of mild or severe dengue. The primers and probes of this test have been designed to detect currently circulating strains of DENV-1-4 from around the world at comparable sensitivity. In a retrospective study with 102 dengue cases confirmed by IgM anti-DENV seroconversion in the convalescent sample, the RT-PCR Assay detected DENV RNA in 98.04% of the paired acute samples. Using sequencing as a positive indicator, the RT-PCR Assay had a 97.92% positive agreement in 86 suspected dengue patients with a single acute serum sample. After extensive validations, the RT-PCR Assay performance was highly reproducible when evaluated across three independent testing sites, did not produce false positive results for etiologic agents of other febrile illnesses, and was not affected by pathological levels of potentially interfering biomolecules. These results indicate that the CDC DENV-1-4 RT-PCR Assay provides a reliable diagnostic platform capable for confirming dengue in suspected cases.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>23875046</pmid><doi>10.1371/journal.pntd.0002311</doi><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access; Public Library of Science (PLoS) |
| subjects | Adolescent Centers for Disease Control and Prevention (U.S.) Dengue - diagnosis Dengue fever Dengue virus Dengue Virus - classification Dengue Virus - genetics Dengue Virus - isolation & purification FDA approval Gene amplification Genomes Humans Illnesses Laboratories Medicine Microbiology Molecular Diagnostic Techniques - methods Pain Real-Time Polymerase Chain Reaction - methods Reproducibility of Results Retrospective Studies Reverse Transcriptase Polymerase Chain Reaction - methods Sensitivity and Specificity Studies United States Virology - methods |
| title | Analytical and clinical performance of the CDC real time RT-PCR assay for detection and typing of dengue virus |
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