First International External Quality Assessment Study on Molecular and Serological Methods for Yellow Fever Diagnosis 英文参考文献.docVIP

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First International External Quality Assessment Study on Molecular and Serological Methods for Yellow Fever Diagnosis 英文参考文献.doc

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First International External Quality Assessment Study on Molecular and Serological Methods for Yellow Fever Diagnosis 英文参考文献

FirstInternationalExternalQualityAssessmentStudyon MolecularandSerologicalMethodsforYellowFever Diagnosis CristinaDomingo1*,CamilleEscadafal1,LeonidRumer1,JairoA.Me′ndez2,PaquitaGarc?′a3, AmadouA.Sall4,AnetteTeichmann1,OliverDonoso-Mantke1,MatthiasNiedrig1 1Centre for Biological Security, Robert Koch Institute, Berlin, Germany, 2Laboratorio de Virolog?′a, Instituto Nacional de Salud, Bogota′, Colombia, 3Laboratorio de EnfermedadesMetaxe′nicas,InstitutoNacionaldeSalud,Lima,Peru′,4InstitutPasteurdeDakar,Dakar,Senegal Abstract Objective: We describe an external quality assurance (EQA) study designed to assess the efficiency and accurateness of molecularandserologicalmethodsusedbyexpertlaboratoriesperformingYFdiagnosis. StudyDesign:Formoleculardiagnosisevaluation,apanelwaspreparedof14humanplasmasamplescontainingspecific RNAofdifferentYFVstrains(YFV-17D,YFVSouthAmericanstrain[Brazil],YFVIvoryC1999strain),andspecificitysamples containing other flaviviruses and negative controls. For the serological panel, 13 human plasma samples with anti-YFV- specificantibodiesagainstdifferentstrainsofYFV(YFV-17Dstrain,YFVIvoryC1999strain,andYFVBrazilianstrain),aswellas specificityandnegativecontrols,wereincluded. Results:Thirty-sixlaboratoriesfromEurope,theAmericas,MiddleEast,andAfricaparticipatedintheseEQAactivities.Only 16%oftheanalysesreportedmetallevaluationcriteriawithoptimalperformance.SerialdilutionsofYFV-17Dshowedthat ingeneralthemethodologiesreportedprovidedasuitablesensitivity.Failuresweremainlyduetotheinabilitytodetect wild-typestrainsorthepresenceoffalsepositives.Performanceintheserologicaldiagnosisvaried,mainlydependingon the methodology used. Anti-YFV IgM detection was not performed in 16% of the reports using IIF or ELISA techniques, although it is preferable for the diagnosis of YFV acute infections. A good sensitivity profile was achieved in general; however,inthedetectionofIgMantibodiesalackofsensitivityofanti-YFVantibodiesagainstthevaccinestrain17Dwas observed, and