用于MPOX(猴痘)诊断的的测试目标产品文件

Circulationofmonkeypoxvirusgloballyhasincreaseddemandfordiagnostics,promptedrapiddevelopmentofcommercialkits,anddrivenexpansionofnetworksoflaboratoriesandhealthfacilitiesofferingdiagnosis.However,aclearneedformoresimplified,automatedand/oraccessibleassaysremains,includingthosethatcanenabletestingatdecentralizedsitesoutsidethelaboratory.Inresponse,toincreaseaccesstoquality-assured,accurateandaffordablempox(monkeypox)diagnosis,anexpertconsultationprocesshasbeeninitiated,resultinginthedraftingoftwotargetproductprofiles(TPPs):1.Testsusedfordiagnosiswithinhealthcaresettingsandlaboratories(TPP1).2.Testsusedasanaidtodiagnosisbydetectingorthopoxvirus(OPXV)antigens,whichareamenabletodecentralizeduse,includinginthecommunity(TPP2).Generallyspeaking,aTPPisaplanningtoolforthedevelopmentofhealthproducts.TheprimarytargetaudienceoftheTPPsaremanufacturers,suppliers,andresearchersdevelopingnewassays.Additionally,countriesandagenciesevaluatingand/orselectingassaysforprocurementanduseformpox(monkeypox)testingacrossbothurbanandruralenvironments,especiallyinsettingswithconstrainedresources,maybenefitfromthecriteriaandinformationpresented.TheTPPsareintendedasastrategicreferencedocumentforcomparisonandtransparency.ThecriterialayoutsomeofthecharacteristicsthataremostrelevanttoinformtheexpeditiousdevelopmentofteststhataddressthegreatestandmosturgentpublichealthneedaccordingtoWHO.AsisthecasewithallWHOTPPs,itisrecognizedthataccess,equity,andaffordabilityareintegralpartsoftheinnovationprocessandneedtobeconsideredatallstages,notjustafteraproductisdeveloped.