QOOLABS INC — Department of Health and Human Services SBIR Phase II: ODCDC

Description

Hepatitis B virus HBV infection is a global health burden with more than million chronically infected individuals around the world In WHO launched the first Guidelines for the prevention care and treatment of persons living with chronic hepatitis B infection promoting the use of simple non invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment Sensitive PCR assays for the detection of HBV nucleic acid including HBV DNA peripheral and intrahepatic HBV DNA and or covalently closed circulating DNA cccDNA are commonly employed to monitor viral replication However these assays are often expensive and cumbersome Serological biomarkers monitoring by immunoassays is a simple and yet efficient way with high throughput potentials It has been demonstrated that the HBV core related antigen HBcrAg p cr has a close correlation with peripheral HBV DNA in untreated patients and the natural course of viral loads in patients under treatment with nucleotide analogue However in the current US market there is no FDA approved HBcrAg assays In this proposal we propose to use Qoolabs proprietary technology to generate antibodies specific to HBcrAg and further use these antibodies to develop sensitive and quantitative immunoassays for serological detection of HBcrAg