DIAGNOSTICS FOR THE REAL WORLD LIMITED — Department of Health and Human Services SBIR Phase I: NIAID

Description

Phase I ApplicationDevelopment of a simple and robust point of care test for detection of Hepatitis C RNA fromfinger prick whole blood in resource limited settingsProject Summary Diagnostics for the Real WorldLtdDRWaims to develop a point of carePOCnucleic acid amplification test for the qualitative detection of Hepatitis C virusHCVThe test will be useful primarily in low and middle income countries with high prevalence of HCVThe tests will be developed and based on DRW s existing SAMBA II systemwhich was designed to allow nucleic acid testing 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 overpatients in rural areas have been tested and received their HIVviral load results on the same dayThe development of the proposed SAMBA II HCV Qualitative Test will be based on the SAMBA II HIVQualitative TestSpecific primers and probes for HCV will be designed and evaluated in the SAMBA II system for sensitivityspecificity and subtype coverageSample preparationamplification and detection steps will be optimized to maximize sensitivity and specificity of the assayDuring the second stage of the projectan internal control will be integratedThis internal control is to control for false negative results and should be present in all to tests to demonstrate that the assay was performed correctlyThe internal control is extractedamplified and detected with the target HCV RNA and controls for all steps of the assayUse of the proposed SAMBA HCV test will allow diagnosis and AVT treatment monitoring of HCV infections in lower level remote health care settingsIn addition to allowing therapy for more patientsit will reduce the massive loss to follow upLTFUexperienced in many countriesIt will also be a way of addressing the neglected health impact of chronic hepatitis C at an early stage to prevent frequently fatal cirrhosis and hepatocellular carcinomaWith the availability of curative HCV treatment and strong desire by the drug manufacturers to increase the testing and diagnosis of HCV infected people coupled with commitment by WHOgovernment agencies around the world and NGOs to testtreat and eliminate HCVa perfect storm is forming and the proposed SAMBA II HCV Qualitative Test is well positioned to support the collective effort Phase I ApplicationDevelopment of a simple and robust point of care test for detection of Hepatitis C RNA fromfinger prick whole blood in resource limited settingsProject Narrative At presentno point of carePOCnucleic acid amplification test exist for hepatitis C virusHCVthat is simple and robust enough to be used by non specialist health care workers in lower level healthcare settings in developing countries with a finger prick whole blood sampleThis Phase I proposal aims to determine the feasibility of developing a simple HCV RNA test to allow diagnosis and monitoring of antiviral therapyAVTfor patients chronically infected with HCV using the SAMBA II POC systemDRW has already developed and CEmarked the SAMBA II POC system and two HIV tests and these will form the basis for the development of the proposed SAMBA II HCV Qual Whole Blood Test