Quick Start Guide

ManualsBrandsGSK Consumer Healthcare ManualsCell PhonesThe product consists of a single use Analyzer module that connects to a smartphone application via Bluetooth Low Energy. The product also includes a sterile swab and collection container and an extraction fluid-filled dispenser.

7Theanalyzerlightissolidred.Whatdoesthismean?Asolidredanalyzerlightindicatesthattheanalyzerisfaulty.

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8Ihaveanosebleedafterswabbingmynose.WhatshouldIdo?Intheunlikelyeventyournosestartsbleeding,apply

pressuretoyournoseand

consultahealthcareprofessional.Donotinserttheswabagain.

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9Iamtryingtosqueezethefluidintothesampleportbutnofluidiscomingout.WhatshouldIdo?Ensuretheswabis

screwedintothedropperastightlyaspossible.Someforcewillberequiredtodo

this.Thentryagainholdingthe

droppercompletelyvertical.Ifthisdoesnotsolvetheproblem,callTheraflu'stoll‐freecustomerhelplineforassistance.

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10DoestheTherafluFluTestdetectCOVID‐19?

No,theTherafluFluTestdetectsinfluenzaAorinfluenzaBandnottheSARS‐CoV‐2

(thecauseofCOVID‐19).Formore

informationonCO VID‐19symptomsandtestingpleasevisit:

https://www.cdc.gov/coronavirus/2019‐ncov/symptoms‐

testing/symptoms.html

ForfurtherFAQsvisitwww.theraflu.com

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Clinicalperformance

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TheperformanceoftheTherafluFluTestwasdeterminedovertwoclinicalstudiesconductedfromDecember2018to

April2019at25geographicallydiversesitesandfromFebruary2020toMarch2020atfivegeographicallydiversesites

throughouttheUSA.AccordingtotheCDC,influenzaAvirusespredominated

duringthe2018/2019influenzaseason

withinfluenzaA(H1N1)pdm09virusesandinfluenzaA(H3N2)virusesmainlyrepresented.InfluenzaBactivitywasvery

low.Duringthe2019/2020influenzaseason,influenzaA(H1N1)pdm09virusesandinfluenzaB(Victorialineage)viruses

weremainlyrepresented.

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Theoverallaccuracyofthetestforthedetection

ofinfluenzaAwhencomparedtothereferenceresult,asdetermined 

bytheconcordancebetweenviralcultureandtwoFDAclearedmoleculartestkits,was95%,withpositivepercent

agreement(PPA)of88%andnegativepercentagreement(NPA)of98%.Theoverallaccuracyofthetestfordetectionof

influenza

Bwas98%withaPPAof79%andNPAof98%.

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TheresultsfortheannualreactivitypanelprovidedbytheCDCcanbefoundonourwebsitewww.theraflu.com

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Ifyouoryourhealthcareprofessionalwouldliketoknowmoreabouthowthetestworksyouwillfindmore

detailsin

theTestResultRecordthatwasemailedtoyou.Alternatively,youorahealthcare professionalcancontactTheraflu's

toll‐freecustomerhelplineatanytime.

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Warningsandprecautions

Storeinadrylocationbetween36‐86°F(2‐30°C)

Keepoutofdirectsunlight

Useat

roomtemperature59‐77°F(15‐25°C)

Keepoutofreachofchildren

X Donotuseafterexpirydate

X Donotuseifanyofthepackagingisopenedordamaged

X Donotre‐use;thisisasingleusetest

X Donotusethistest

astheonlyguidetomanageyourillness,particularlyifyourtesthasnotdetected

 flu.Pleaseconsultahealthcareprofessionalifsymptomspersistorbecomemoresevere

! Avoidperformingthetestinaverydryenvironment(verylowhumidity)topreventabuildupof

 staticelectricitythatcould

damagetheelectronicsofthetest

! Atestresultwillbelessreliablewhenthereisverylittlefluinthecommunity(outsidefluseason,and

 intheveryearlyandverylatestagesofthefluseason).Pleaseconsultahealthcareprofessionalif

youareconcernedabout

yourhealth,ifyoursymptomspersist,orifsymptomsbecomemoresevere