Evaluation of Two New Commercial Tests for the Diagnosis of Acute Dengue Virus Infection Using NS1 Antigen Detection in Human Serum 英文参考文献.docVIP
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Evaluation of Two New Commercial Tests for the Diagnosis of Acute Dengue Virus Infection Using NS1 Antigen Detection in Human Serum 英文参考文献
EvaluationofTwoNewCommercialTestsforthe
DiagnosisofAcuteDengueVirusInfectionUsingNS1
AntigenDetectioninHumanSerum
PhilippeDussart1*,LaurePetit2,BhetyLabeau1,LaetitiaBremand1,AlexandreLeduc1,DavidMoua1,
Se′verineMatheus1,LaurenceBaril3
1CentreNationaldeRe′fe′rencedesArbovirusetVirusInfluenza,Re′gionAntilles-Guyane,InstitutPasteurdelaGuyane,Cayenne,FrenchGuiana,2Unite′ d’Epide′miologie
desMaladiesEmergentes,InstitutPasteur,Paris,France,3Unite′ d’Epide′miologie desMaladiesInfectieuses,InstitutPasteurdeDakar,Dakar,Se′ne′gal
Abstract
Background:WecomparedtheperformanceoftwonewcommercialtestsforthedetectionofdengueNS1proteinduring
theclinicalphaseofdenguevirus(DENV)infection—animmunochromatographictestallowingrapiddetectionoftheNS1
antigen, Dengue NS1 Ag STRIP (Bio-Rad Laboratories - Marnes La Coquette, France), and a two-step sandwich-format
microplateenzyme-linkedimmunosorbentassay(ELISA),pan-EDengueEarlyELISA(Panbio-Brisbane,Australia)—witha
one-stepsandwich-formatmicroplateELISA,thePlateliaDengueNS1Agtest(Bio-Rad).
Methods:Wetested272serumsamplesfrompatientswithdenguedisease.Ofthese,222werefrompatientswithacute
infectionofoneofthefourdengueserotypes,detectedbyRT-PCRand/orvirusisolation.Forty-eightacute-phaseserum
samplesfrompatientsnotinfectedwithdengueviruswerealsoincluded.
Results:ThesensitivityofthePlateliaDengueNS1Agtestonacuteserumsamples(n=222)was87.4%(95%confidence
interval:82.3%to91.5%);thatofDengueNS1AgSTRIPwas81.5%(95%CI:75.8%to86.4%)after15minutesand82.4%
(95%CI:76.8%to87.2%)after30minutes.Bothtestshadaspecificityof100%(97.5%CI,one-sidedtest:92.6%to100.0%).
Thepan-EDengueEarlyELISAhadasensitivityof60.4%(95%CI:53.4%to66.8%)andaspecificityof97.9%(95%CI:88.9%
to99.9%).
Conclusion:OurfindingssupporttheuseofdiagnostictoolsbasedontheNS1antigendetectionforthediagnosisofacute
DENV infection. The immunochromatographic test, Dengue NS1 Ag STRIP—the first rapid diagnostic test for DENV
infection—washighlysensitiveandspecific,andwouldthereforebeasuitabl
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