Pan-HIVIncidenceAssayDevelopment Abstract HIV-1continuestocausethelargestnumberofyearlydeathsfromasingleinfectiousagentintheworldtoday. Despite considerable advances in treatment of HIV-1 infection and AIDS, which it causes, there is an urgent needforbettermethodsofpreventionandtreatmentofHIV-1infectionandAIDS.Aspartofthiseffort,theWorld HealthOrganization(WHO)andtheJointUnitedNationsProgramonHIV/AIDS(UNAIDS)conductworldwide surveysofHIVinfectionincidence,prevalenceandmortality.Incidencedataarevitallyneededbygovernments and non-governmental organizations to best direct efforts and limited resources aimed at prevention of HIV transmissionandtreatmentofHIVinfection.Thelimitingantigenavidityenzymeimmunoassay(Lagassay)is currentlywidelyusedtotestforHIVincidencebutthisassayonlydetectsveryrecentinfectionsanddoesnot workwellforallsubtypesofHIV-1. AntigenDiscoveryInc.(ADI),ofIrvineCalifornia,hascreatedapan-HIVproteomicmicroarray(pan-HIVchip) that contains all proteins and many protein fragments and epitopes from nine HIV-1 subtypes and circulating recombinantformsaswellasbothmajorgroupsofHIV-2,whichtogethercompriseover90%ofHIVinfections worldwide. We also added glycosylated and disulfide-bound forms of HIV glycoproteins and glycoprotein fragments resulting in a total of over 280 immunoreactive HIV proteins, proteins fragments and epitopes. Moreover,weassayedthereactivityofthisHIVproteinmicroarraywithIgG,IgAandIgMinapanelof125sera andsalivasamples,obtainedfromtheConsortiumfortheEvaluationandPerformanceofHIVIncidenceAssays (CEPHIA), that comprise the HIV Recency Biomarker Screening (HRBS) set. Our preliminary data show that certainHIVantigens,Vif,Vpu,p6,Tat,Rev,EnvandEnvfragmentsaremuchlessstronglyrecognizedbyIgG inseraandsalivafromrecentlyinfectedindividualscomparedtothosewithlonger-terminfection.Incontrast, Env,Envfragments,Tat,Rev,CAandPRaremorestronglyrecognizedbyIgMinseraandsalivafromrecently infectedindividualscomparedtothosewithlonger-terminfection.Basedontheseextensivepreliminarydata, we hypothesize that we can develop a highly sensitive and specific HIV recency of infection testing algorithm(RITA)thatwillbeusefulforindividualsinfectedwithalltypesandsubtypesofHIV.