HIV, Hepatitis B, hepatitis C

 BACKGROUND

According to WHO’s 2022–2030 global health sector strategies (GHSS) aimed at ending AIDS, viral hepatitis B and C, and other sexually transmitted infections by 2030, HIV and viral hepatitis continue to impose a major public health burden, with hundreds of millions of people already infectred worldwide, as well as 4.5 million new infections with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV) and over 1.1 million deaths each year. Available literature suggests that there is a faster progression of HIV infection in those co-infected with either HBV or HCV, progressively worsening patient prognosis and shortening life span. An estimated 80-90% of all people living with HBV or HCV, and potentially co-infected with HIV, remain undiagnosed and untreated each year, leading to increased morbidity and death due to cirrhosis and hepatocellular carcinoma (HCC). In the United States alone, it is estimated that only 15% of all people living with HBV are aware of their status, and of these, only 4.5% are treated. These global gaps highlight the critical need for new and better integrated strategies for screening and diagnosis both of HIV and viral hepatitis infections, which will be critical to an effective global health response.

A NEW SEROLOGICAL TRIPLEX TEST FOR HIV, HBV, AND HCV

Numerous tests to determine infection by HBV, HCV, or HIV have been developed and commercialized, many of which are FDA-approved, CE-marked, or WHO pre-qualified (PQ). The majority of these tests are not multiplexed, hence limited to the diagnosis of one disease at a time. A few multiplex tests exist, among which dual HBV/HCV or HIV/HCV tests, as well as triplex HBV/HCV/HIV tests, the majority of which are mixed antigen/antibody tests that are based on detecting an HBV surface antigen as well as the antibodies raised by the human host against HCV and HIV. In contrast, our triplex test will be a pure serological test capable of separately detecting antibodies against specific antigens each of HIV, HBV, and HCV. Our test will differentiate itself from the only directly comparable serological competitor test by a 5- to 10-fold lower cost and a better thermal stability allowing it to work perfectly in extreme tropical climates. Finally, it will come with our smartphone-based reader app to help end users interpret the results more easily and store them in a cloud-based repository for later retrieval.

An NIH Phase I Contract has allowed us to develop, optimize, and validate highly sensitive and specific monoplex tests for HIV, HBV, and HCV. The assay conditions of the monoplex tests were purposely optimized in such a way as to facilitate their subsequent consolidation into a single triplex test in future work.