Research Project
9559232
Phase I Application: Development of a simple and robust point-of-care test for detection of Hepatitis C RNA from finger prick whole blood in resource-limited settings. Project Summary Diagnostics for the Real World, Ltd (DRW) aims to develop a point-of-care (POC) nucleic acid amplification test for the qualitative detection of Hepatitis C virus (HCV). The test will be useful primarily in low and middle-income countries with high prevalence of HCV. The tests will be developed and based on DRW?s existing SAMBA II system, which was designed to allow nucleic acid testing in POC settings in developing countries, by minimally trained staff and without the need for expensive equipment or temperature controlled transport and storage. DRW has SAMBA HIV-1 qualitative and semi-quantitative tests on the market with the latter in use in Malawi and Uganda by Médecins Sans Frontières (MSF), where over 60,000 patients in rural areas have been tested and received their HIV-1 viral load results on the same day. The development of the proposed SAMBA II HCV Qualitative Test will be based on the SAMBA II HIV-1 Qualitative Test. Specific primers and probes for HCV will be designed and evaluated in the SAMBA II system for sensitivity, specificity and subtype coverage. Sample preparation, amplification and detection steps will be optimized to maximize sensitivity and specificity of the assay. During the second stage of the project, an internal control will be integrated. This internal control is to control for false negative results and should be present in all to tests to demonstrate that the assay was performed correctly. The internal control is extracted, amplified and detected with the target HCV RNA and controls for all steps of the assay. Use of the proposed SAMBA HCV test will allow diagnosis and AVT treatment monitoring of HCV infections in lower-level remote health care settings. In addition to allowing therapy for more patients, it will reduce the massive loss to follow-up (LTFU) experienced in many countries. It 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 carcinoma. With 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 WHO, government agencies around the world and NGOs to test, treat and eliminate HCV, a perfect storm is forming and the proposed SAMBA II HCV Qualitative Test is well positioned to support the collective effort.
