Development of two simple and robust point-of-care assays for detection and therapy monitoring of hepatitis B in resource-limited settings

SBIR Direct Phase II Application Development of two simple and robust point of care assays for detection and therapy monitoring ofhepatitis B in resource limited settings Project Summary Abstract Diagnostics for the Real WorldLtdDRWaims to develop and evaluate two point of carePOCnucleic acid amplification testsNAATfor Hepatitis B virusHBVHBV qualitative detection at a high sensitivity andHBV semi quantitative detection above or below a clinically significant cut off for monitoring antiviral therapyAVTThe test will be useful primarily in Sub Saharan AfricaSSAand other developing countries where HBV has a high prevalence and often exists as co infection with Human Immunodeficiency virusHIVThe tests will be developed and based on DRW s existing SAMBA systemwhich was designed to allow NAAT use in POC settings in developing countriesby minimally trained staff and without the need for expensive equipment or temperature controlled transport and storageDRW has SAMBA HIVQualitative and Semi quantitative tests on the market with the latter in use in Malawi and Uganda by M decins Sans Fronti resMSFwhere oversamples have been run on SAMBA in rural areasThe development of the HBV qualitative test will be based on the SAMBA HIVQualitative testThe HBV semi quantitative test will be developed based on the SAMBA HIVSemi quantitative testbut with a cutoff ofIU mlrecommended internationally for indication of AVT for chronic Hepatitis BCHBand for monitoring of therapeutic efficacyrather than theIU ml cutoff used for HIVtreatment efficacy monitoringPreliminary evaluation on panels covering all HBV genotypes and a range of HBV viral loads in left over clinical samples will be conducted in houseThe tests will then be evaluated in Ghana and Zimbabweexamples of environments where the tests are intended for use and where HBV prevalence is highAfter evaluationsDRW will submit the tests for WHO prequalificationCE marking and in country approvals in AfricaUse of the SAMBA HBV tests will allow diagnosis and AVT monitoring of HBV infections in lower level remote health care settingsIn addition to allowing therapy for more patientsit will reduce the massive loss to follow upLTFUexperienced in SSA with HIV Anti retroviral therapyARTIt will also be a way of addressing the neglected health impact of chronic hepatitis BCHBat an early stage to prevent frequently fatal cirrhosis and hepatocellular carcinomaWHO has stated in their document WHAthat hepatitis is a significant health care issue that needs to be addresses in the same way that HIVis being addressed and recommends provisions be made to diagnosetreat and monitor hepatitisespecially in the developing worldwhich does not have the same access to care as the developed worldThe SAMBA HBV tests proposed in this application will support these WHO recommendations