Hepatitis C infection is among the major public health concerns in the US and worldwide. According to the CDC, 3 million individuals in the US (170M worldwide) are infected with HCV. As most HCV cases are asymptomatic only 45% of the patients in the US (and about 15% worldwide) are aware of their infection status. With the recent availability of effective oral therapies providing cure for HCV, interest over currently available diagnostics has increased. With this interest the unmet needs in the HCV diagnosis became more apparent. Unfortunately low cost, easy to operate antibody serological assays cannot detect early infection and cannot differentiate self-healed cases. PCR based nucleic acid amplification tests are highly sensitive but also costly and infrastructure dependent. HCV core Antigen is another biomarker that is highly correlated with the Hepatitis C viral load. In this research project we aim to develop an affordable, rapid, highly sensitive and automated Hepatitis C diagnostic test to be performed at the point of care and low resource settings with 5-10ul sample blood obtained via finger prick. The novel diagnostics platform will enable quantitative detection of HCV core antigen to provide clinically relevant viral load information accompanying a positive assay result. In the development of highly sensitive assay, Correlia?s novel hydrogel based assay platform will be utilized. This novel method enables rapid operation of protein assays in an automatable and portable platform such that traditional assays could be run in 10-100x times faster. For HCV antibodies we have demonstrated 12x faster assays.
The specific aims of the Phase I project are tailored to address more risk bearing tasks first. These tasks will include, 1) Selection of capture and detection antibodies that provide highest specific signal with lowest background and nonspecific signal. 2) Characterization of assay parameters to achieve highest sensitivity within a 20 minute assay runtime, and determination of dynamic range, lower and upper limits of detection along with incorporation of signal amplification methods to further increase the sensitivity. 3) Assessment of the preliminary clinical sensitivity and specificity with de-identified, commercially available HCV positive and negative patient samples. Successful completion of the SBIR Phase I research will demonstrate the feasibility for detecting HCVcAg in our platform within 20 minutes with high sensitivities that can be correlated to the status of the infection (i.e. the viral load). During phase II studies, remaining technical tasks that do not require new feasibility assessments will be addressed. The outcome of this project will have a global impact enabling millions of individuals have access to an affordable, rapid and assured diagnostics capability against HCV at their close proximity.
The goal of this project is to develop an affordable, rapid, highly sensitive and automated Hepatitis C diagnostic test to be performed at the point of care and low resource settings with sample blood is obtained via finger prick. The novel diagnostics platform will enable quantitative detection of HCV core antigen to provide clinically relevant viral load information accompanying a positive assay result.