RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis B Virus Surface Antigen (HBsAg) Point-of-Care (POC)* Diagnostics

Overview

In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for hepatitis B virus surface antigen (HBsAg) detection.

Hepatitis B is a viral infection that can cause both acute and chronic liver disease. The virus is transmitted through contact with infected blood or body fluids, including from mother to child during pregnancy and delivery, sex with an infected partner, injection drug use, or exposures to contaminated sharp instruments. Chronic hepatitis B is a major cause of liver cirrhosis and hepatocellular carcinoma (primary liver cancer). In 2022, an estimated 1.6 million individuals in the United States tested positive for HBsAg, and approximately 3,100 deaths were attributed to hepatitis B. Hepatitis B virus (HBV) infection can be prevented by vaccines that are safe, available, and effective. Treatment for hepatitis B include antivirals and interferon injections which must be taken for life.

More than half of individuals with hepatitis B are unaware of their infection status. Approximately 50%–70% of individuals with acute hepatitis B are asymptomatic, and those who progress to chronic hepatitis B are typically asymptomatic for several years to decades until the development of HBV-related complications including cirrhosis, hepatocellular carcinoma, or extra-hepatic manifestations. Without testing, individuals with HBV infection can unknowingly transmit the virus to others. Routine monitoring and treatment for chronic HBV infection can reduce morbidity and mortality, supporting the importance of early detection of HBV infection.

After infection with HBV, HBsAg is the first antigenic marker, appearing 1 to 12 weeks after exposure and 2 to 6 weeks before the onset of clinical symptoms. HBsAg persists during this acute phase and clears late in the convalescent period. Failure to clear HBsAg within 6 months indicates a chronic HBV infection.

Because of overlapping risk factors, individuals with HIV or hepatitis C virus (HCV) infection are recommended to be tested for HBV. Further, people who are co-infected with HBV infection plus HIV and/or HCV infection are at higher-risk for HBV-related complications. For example, taking direct-acting antivirals (DAAs) to treat HCV can cause HBV to reactivate in individuals who have had or are carriers of HBV. This reactivation can lead to serious liver problems, including liver failure and death. For this reason, HBV testing is recommended (along with HIV and pregnancy testing) for all people with hepatitis C prior to initiating DAA treatment. While FDA approved/cleared POC tests already exist for HIV and pregnancy, there are currently no POC tests available in the United States to detect HBV infection. The intended use for HBsAg tests is for the testing of individuals at risk or with signs and symptoms for HBV infection.

NIH is mobilizing and expanding the focus of the RADx Tech Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable HBsAg tests. ITAP plans to provide support required to accelerate test validation and regulatory review of POC tests utilizing fingerstick blood samples. These efforts will facilitate rapid production and commercialization of HBsAg POC tests in the US.

ITAP will consider applications from test manufacturers with existing technologies that can quickly enter high volume production and can meet the FDA’s performance/quality standards for authorization.

Evaluation Criteria

Organizations applying to ITAP will be evaluated based on several criteria, including but not strictly limited to:

Demonstrated capacity for high volume manufacturing and distributing high-quality in-vitro diagnostics, AND at least one of the following:

1. An existing technology adapted for POC detection of HBsAg, at or near design lock, with analytical and clinical performance data available
2. An existing HBsAg test kit, available for POC diagnostic use in international markets

Begin your application here.

Questions? Please visit the FAQs page or send inquiries to itapnibib@mail.nih.gov.

*Point-of-care (POC) typically refers to patient care settings where testing can be completed near the patient, such as at the bedside in a hospital or at a health clinic, physician office, or pharmacy. POC settings performing clinical testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS).