Point-of-Care Rapid RNA test for HIV

Point of Care Rapid RNA test for HIV PhaseCrossLife Technologies IncProject Summary Abstract Current antibody point of care tests cannot distinguish between a motherandapos s and babyandapos s antibodies to detect if an infant has become infected with Human Immunodeficiency VirusHIVAccording to a recent WHO UNAIDS UNICEF reportonly a predictedpercent of babies born to HIV positive mothers obtained an HIV test within the first two monthsThereforethere are unmet needs for new and renovated test that can be applied at the point of care to detect HIV infectionsA rapidsensitivespecific simple and cost effective paper strip molecular test that detects HIV at the point of care was developed by integrating TARA chemical and device innovationsThe target sequences are amplified using the TARATemplate Assisted Rapid Assaytechnology which is composed of a template dependent chemical transfer reaction with high turnovergold nanoparticle HRPand lateral flow readoutThe test should be rapidandltminutesand results in the appearance of colored bands that are detectable by eyeThe resulting cartridge similar to a pregnancy test will automate all steps of molecular analysis and amplification for detection of HIV RNAs in blood finger stick without sample preparationIn Phasewe demonstratedsensitivity and specificity for our assay on a small number of simulated clinical samplesThis is well above levels reported in studies of the Alere Q and SAMBA point of care HIV assaysThe goal of this Phaseproposal is toPaper microfluidics for TARA assay automationverify the performance of our TARA HIV test using a large number of clinical samplesnand thenpursue World Health OrganizationWHOexpedited review approval and recommendation for procurement on our productAfter initial marketing of the test developed in Phasewe plan to pursue CLIA waiver in order to allow for untrainedlay persons to operate the testThis approach is largely due to the extended budget and timeline that will be required to cover further development of our test to make it CLIA waivedOur test will be more rapid than the RT PCR tests because the results will be available at the point of need and not in a laboratory where the instrument is located Point of Care Rapid RNA test for HIV PhaseCrossLife TechnologiesIncRESEARCH andampRELATED Other Project Information Narrative Globallyit is estimated that more thanmillion people living with the human immunodeficiency virusHIVinover half of them were womenEarly Infant DiagnosisEIDof HIV has become a new priority for the US President Emergency Plan for AIDS ReliefPEPFARsinceThe rapid antibody test is difficult to interpret in infants and young children due to the continuance of maternal HIV antibodiesThe proposed research will enable sensitiveaccurate point of care RNA detection for HIV