Interim WHO guidance for the surveillance of human infection

with swine influenza A(H1N1) virus

27April2009

Introduction
TheaudiencesforthisguidancedocumentaretheNationalFocalPointsfortheInternational
HealthRegulations(IHR(2005))andcompetentnationalpublichealthauthorities.Theprimary
focusofthisguidancedocumentisglobalsurveillance.Italsogivessomesuggestionsonthe
typesofsignalsthatMemberStatesandIHRStatesPartiescancaptureintheireventbased
surveillance.Thesesignalscanaididentificationofindividualsforwhominvestigationofswine
influenzaA(H1N1)virusinfectioniswarranted.

ThisisaninterimWHOguidanceontheglobalsurveillanceoftheemergingswineinfluenza
A(H1N1)virusinfection.Thisisalivingdocumentthatwillbereviewedonaweeklybasisand
modifiedinaccordancewithchangesintheepidemiologyofthisvirus.Astheeventevolves,
therewillbeaneedtoswitchsurveillanceactivitiestothelongertermmonitoringofthe
disease.WHOwillalertcountrieswhenachangeinsurveillanceobjectivesandmethodsoccurs.
WHOsdatarequirementswillremainasflexibleaspossibletoaccommodatedifferent
surveillancesystemsandreportingcapacityaroundtheworld.

ThisdocumentwillformpartofasuiteofguidancedocumentsbeingproducedbyWHOin
responsetothispublichealthemergencyofinternationalconcernasdeterminedbytheDirector
GeneralofWHOon25April2009.Newinfluenzavirussubtypesandclustersofunknownand
unusualdiseasearenotifiabletoWHOinaccordancewiththeAnnex2decisioninstrumentof
theIHR(2005).

AtthisearlystageoftheoutbreakofswineinfluenzaA(H1N1)virus,themainaimsof
surveillancearetheearlywarningofvirusspreadandlaboratoryconfirmationofvirus
circulatinginnewgeographicalareasandcountries.Accordingly,WHOencouragesallMember
StatesandIHRStatesPartiestoenhancetheirsurveillanceanddiagnosticcapacityforinfluenza
andotheracuterespiratoryinfections,buildingonexitingsurveillancestructureandresources.

Objectivesofenhancedglobalsurveillanceforhumaninfectionswithswineinfluenza
A(H1N1)virus

Specificobjectivesofthissurveillanceactivityaretoguideglobalpreventionandcontrol
activitiesthroughthefollowingactions:

1. DetectandconfirmcasesofswineinfluenzaA(H1N1)virusinfection
2. EstablishtheextentofinternationalspreadofswineinfluenzaA(H1N1)virusinfection
3. Assistintheearlyseverityassessmentofthedisease

CasedefinitionsforinfectionswithswineinfluenzaA(H1N1)Virus
In order to understand the spectrum of severity of the disease caused by swine influenza
A(H1N1) virus infection , the clinical case description includes both mild form of influenzalike
illness(ILI)andmoresevereforms(lowerrespiratorytractinfectionsincludingpneumoniaand
severe acute respiratory illness (SARI)). In addition, asymptomatic laboratoryconfirmed
infectionsshouldbereported.

Thefollowingcasedefinitionsareforthepurposeofreportingprobableandconfirmedcasesof
swineinfluenzaA(H1N1)virusinfectiontoWHO.

Clinicalcasedescription
Acutefebrilerespiratoryillness(fever>38C)withthespectrumofdiseasefrominfluenzalike
illnesstopneumonia.

1. AConfirmedcaseofswineinfluenzaA(H1N1)virusinfectionisdefinedasanindividual
withlaboratoryconfirmedswineinfluenzaA(H1N1)virusinfectionbyoneormoreof
thefollowingtests*:
realtimeRTPCR
viralculture
fourfoldriseinswineinfluenzaA(H1N1)virusspecificneutralizingantibodies.

2. AProbablecaseofswineinfluenzaA(H1N1)virusinfectionisdefinedasanindividual
withaninfluenzatestthatispositiveforinfluenzaA,butisunsubtypablebyreagents
usedtodetectseasonalinfluenzavirusinfectionOR
Aindividualwithaclinicallycompatibleillnessorwhodiedofanunexplainedacute
respiratoryillnesswhoisconsideredtobeepidemiologicallylinkedtoaprobableor
confirmedcase.
*Note:Thetest(s)shouldbeperformedaccordingtothemostcurrentlyavailableguidanceon
testing(http://www.who.int/csr/disease/swineflu/en/index.html).

ReportingrequirementsforconfirmedandprobablecasesofswineinfluenzaA(H1N1)

Under the IHR (2005), immediate reporting to WHO is required for human influenza due to a
newinfluenzavirussubtype.AllinformationwillbetreatedinaccordancewiththeIHR(2005)
provisions.

ReportsshouldbesentbytheNationalIHRFocalPointtotherelevantWHOIHRContactPointat
the WHO Regional Office, the WHO Country Representative, where applicable, and WHO
headquarters
in
Geneva
should
be
copied
on
the
correspondence
(http://www.who.int/csr/alertresponse/ihreventinfo/).

Reportingofindividual(s)orclustersunderinvestigationforswineinfluenzaA(H1N1)
virusinfection

Countries that identify unusual clusters of acute respiratory illness should immediately notify
WHO. These consultations will not be reflected in global statistics until their investigation
confirmsthattheyarelaboratoryconfirmedorprobablecases.

Definitionofcluster
A cluster is defined as two or more persons presenting with manifestations of unexplained,
acuterespiratoryillnesswithfever>38Corwhodiedofanunexplainedrespiratoryillnessand
thataredetectedwithonsetofillnesswithinaperiodof14daysandinthesamegeographical
areaand/orareepidemiologicallylinked.

Triggers/signalsfortheinvestigationofpossiblecasesofswineinfluenzaA(H1N1)
The primary focus of early investigation is to trigger the initial investigation. Specific triggers
include:

ClustersofcasesofunexplainedILIoracutelowerrespiratorydisease

Severe, unexplained respiratory illness occurring in one or more health care worker(s)
whoprovidecareforpatientswithrespiratorydisease

ChangesintheepidemiologyofmortalityassociatedwiththeoccurrenceofILIorlower
respiratory tract illness, an increase in deaths observed from respiratory illness or an
increaseintheoccurrenceofsevererespiratorydiseaseinpreviouslyhealthyadultsor
adolescents

Persistent changes noted in the treatment response or outcome of severe lower

respiratoryillness.

EpidemiologicalriskfactorsthatshouldraisesuspicionofswineinfluenzaA(H1N1)include:

Closecontact#toaconfirmedcaseofswineinfluenzaA(H1N1)virusinfectionwhilethe
casewasill

RecenttraveltoanareawherethereareconfirmedcasesofswineinfluenzaA(H1N1)

#
Closecontact:havingcaredfor,livedwith,orhaddirectcontactwithrespiratorysecretionsor
bodyfluidsofaprobableorconfirmedcaseofswineinfluenzaA(H1N1).

MemberStatesreportingcasesofswineinfluenzaA(H1N1)virusinfectionforthefirsttime

AssoonasatheNationalIHRFocalPointorcompetentnationalpublichealthauthoritynotifies
WHOofthefirstlaboratoryconfirmedorprobablecase(s)ofswineinfluenzaA(H1N1),WHOwill
make available the case summary form and database for the recording of detailed clinical,
laboratoryandepidemiologicaldatainaccordancewithWHOpandemicsurveillanceguidelines.
Member States where cases of swine influenza A(H1N1) virus infection have already been
reported

Until further notice, the National IHR Focal Points or competent national public health
authorities should report to WHO all probable and confirmed cases on a daily basis. Deaths
shouldbereportedforbothprobableandconfirmedcases.

WHOwillpresentthecumulativenumberofcasesforglobalreportingbacktoMemberStates
andthepublic.Thisactivitywillonlycontinuefortheinitialperiodofdatacollection.

Inordertounderstandtheseverityofthediseaseitisveryimportantthatcomprehensivedata
collectionandfollowupiscarriedoutforallprobableandconfirmedcasesofswineinfluenza
A(H1N1)virusinfection.WHOsdatarequirementsaredetailedintheGlobalSurveillanceduring
anInfluenzaPandemicVersion1UpdateddraftApril2009(ComprehensiveAssessment,Clinical
characteristics:Databaseofinformationfor100cases).Manycountriesandterritorieswillhave
already developed questionnaires for influenza A(H5N1) related investigation. These can be
adapted and used for the investigation of individuals for whom swine influenza A(H1N1) virus
infectionisconsidered.

Confirmedandprobablecasesreportedaretobeattributedtothecountryorterritoryinwhich
theyarecurrentlylocatedorwheretheyhavedied.Changesincaseclassificationfromprobable
toconfirmed,aswellasdeterminationofthefinaloutcomeofthedisease,shouldbesignalled
whenreportingandwillbereflectedintheupdatestobepublishedbyWHO.

The reported casebased data will be used by WHO to compile daily global surveillance
summaries. These summaries will be presented on the WHO headquarters website
(http://www.who.int)asthelatestcumulativecasecountandmapsofgeographicaldistribution.

AccesstoLaboratoryConfirmation

CountrieswithoutcurrentcapacitytoconfirmswineinfluenzaA(H1N1)shouldcontactWHOto
arrangeaccesstoalaboratorywiththiscapability.