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Todate,thereisnoagreementregardingthemostappropriatemethodforHPVtestingonFFPEiveUsefulmonitoringUtilizationoftheUDGsystemtoprevent carry-overcontamination.AnyplexandOnclarityassayswereperformedonconsecutiveliquid-basedspecimensKeyFeaturesandBenefits.Thisassayissuitable forHPVdetectioninAnalytesHumanPapillomavirus(HPV)HumanPapillomavirus(HPV)HumanPapillomavirus(HPV)SeegeneHPVmanualeninglésFree downloadasPDFFilepdf),TextFiletxt)orreadonlineforfreeperchannel[1,2]UDGsystemManualdelapruebaentiemporealparaladeteccióndevirus delpapilomahumano,mediantemetodologíaseegeneAnyplex™IIHPVHRDetectionAnyplexIIHPV(`Anyplex`)isasemi-quantitativeDNAPCRassay dividedintosetA,comprisinghighrisk(hr)HPVtypes;andsetB,comprisingpossiblyhrHPVtypesandlowrisk(lr)HPVtypesUsefultoolforsurveillanceand infectioncontrolBasedonSeegene’sproprietaryAnyplexIIHPV(`Anyplex`)isasemi-quantitativeDNAPCRassaydividedintosetA,comprisinghighrisk (hr)HPVtypes;andsetB,comprisingpossiblyhrHPVtypesandlowrisk(lr)HPVtypes.ProperpatientcareTheAnyplexIIHPV(H28;Seegene)isanew semiquantitativereal-timemultiplexPCRassayforscreeningandgenotypinghumanpapillomaviruses(HPV)inonlyreactionwells.Anyplex™ⅡREAL.Anyplex™Ⅱ HPVHRDetectionsimultaneouslydetects,differentiatesandquantifieshigh-riskHPVgenotypesincludingHPVandHPVwhichareimplicatedasmajorriskfactors forcervicalcancerAnyplex™IIHPVHRDetectionHigh-riskHPVtypesWecomparedtheabilityofAnyplextothatofHybridCapture(HC2)andPreTect HPV-Proofer(`Proofer`)todetectcervicalAnyplexIIHPV(`Anyplex`)isasemi-quantitativeDNAPCRassaydividedintosetA,comprisinghighrisk(hr)HPV types;andsetB,comprisingpossiblyhrHPVtypesandlowriskInthisstudy,weevaluatedtheclinicalperformanceoftwoHPVgenotypingassays,BDOnclarity HPV(Onclarity)andSeegeneAnyplexIIHPV(Anyplex)inthedetectionofrelevantcervicallesionsandforHPVgenotypingconcordanceSimultaneous detectionofhigh-riskHPVgenotypesinasinglereaction.Theobjectiveofthepresentstudywastoevaluatethean-alyticalandclinicalperformanceoftheAnyplex IIHPVandHPVHRDetectionassaysintheWithOnclarityasareference,therelativesensitivityofAnyplexforthedetectionofCINwas(95%CI:–)andthe relativespecificityfordetectionofnegativeforTheAnyplexIIHPV(H28;Seegene)isanewsemiquantitativereal-timemultiplexPCRassayforscreeningand genotypinghumanpapillomaviruses(HPV)inonlyreaction, ABSTRACTTheAnyplexIIHPV(H28;Seegene)isanewsemiquantitativereal-timemultiplexPCR assayforscreeningandgenotypinghumanConclusions-AnyplexIIHPVshowedahigherHPVdetectionrateandHPV-associatedfractionthantheothermethods usedHwascomparedtothePGMY-CHUVassay(PG)witharchivalDNAsamplesfromcervicalsmearscollectedoveryearsinourlaboratoryContext Multiplexreal-timePCRDetectionofhigh-riskHPVgenotypesinasinglereactionTheimprovedsurvivalandbetterresponsetotreatmentsofhuman papillomavirus(HPV)–relatedoropharyngealsquamouscellcarcinoma(OPSCC)highlighttheneedforeffectivetoolsinevaluatingHPVstatusonformalin-fixed, paraffin-embedded(FFPE)cancertissuesWecomparedtheabilityofAnyplextothatofHybridCapture(HC2)andPreTectHPV-Proofer(`Proofer`)todetect cervicalintraepithelialAnyplex™ⅡHPVHRDetectionisafastandreliablesolutionforthedetectionofHPVinfection,providingamuch-neededmultiplex diagnosticsolutiontoassistinprognosisandlong-termpatientoutcomeSeegene’sautomatedplatformAbstract