Rapid point-of-care test for hepatitis C virus (HCV) core antigen to screen active HCV infection

Project Summary / Abstract The number of people testing positive for hepatitis C virus (HCV) has increased significantly in the last decade and younger adults contracting the virus has become more common. Now, roughly 50,000 infections are expected each year and about 40% of the people are not aware of their infections.

Although, about half of these acute infections can be cleared by the individual, the remainder will become chronically infected. If hepatitis C is undiagnosed and remains untreated, severe liver damage and death can occur. HCV related liver damage is now a leading cause of death in the U.S., claiming ~15,000 lives annually.

Although no vaccine for HCV is currently available, effective anti-retroviral treatment does exist to treat the disease with over 95% cure rate. Hence, identifying people with hepatitis C (chronic infection) is a critical task to treat and stop the spread of HCV. Currently, screening and diagnosing active HCV infection requires two tests.

One antibody test to determine prior exposure and one nucleic acid test (NAT) to confirm an active infection.

However, this two-step procedure is cumbersome and heavily relies on clinical laboratories; additionally, the antibody is not sensitive in the first two months of a new HCV infection and missing these cases. Hence, the current testing procedure has become the bottleneck for screening hepatitis C.

Besides the current two-step approach, HCV core antigen (cAg) test has been proposed as an equally effective approach for screening and diagnosing active HCV infections.

Numerous clinical studies since the 2000s have demonstrated a highly sensitive cAg test can be used to screen active HCV infection as effectively as NAT.

However, all currently available HCV cAg test can only be performed in a laboratory setting and require trained personnel for operation and maintenance.

As a result, this Phase I project is proposed to demonstrate the feasibility of developing a highly sensitive cAg test that can be performed quickly and accurately at the point-of- care (POC) by utilizing a detection platform based on the existing Blood Glucose Meter (BGM) hardware and a disposable microfluidic assay cartridge.

Today?s BGM is the culmination of decades of R&D, designed for small footprint, simple operation, low cost and large-scale production.

Leveraging the BGM technology with a familiar assay format for new applications allows us to reduce the risk and costs associated with device development and scale-up production.

The final product will be a POC system composed of a BGM based meter and disposable cartridges for HCV cAg for measuring cAg levels in high risk individuals.

The new POC HCV cAg test will be able to quickly identify individuals with chronic HCV infection and allow early curative treatment.

The proposed product will also greatly benefit developing countries with high HCV prevalence but lacking testing infrastructure.

The project will include three development goals, including 1) develop and optimize a highly sensitive cAg test using the BGM platform; 2) validate the BGM based cAg test in biological samples; and 3) integrating the optimized assay with an existing prototype system.