用于MPOX(猴痘)诊断的的测试目标产品文件
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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.
提供机构：
世界卫生组织（WHO）
