Analytical and clinical performance of the high sensitive Simoa qHBsAg assay

2016 Biomarkers & Diagnostics World Congress, Philadelphia, PA

Célia Galien, Camila Rocaboy, Françoise Forge, Catherine Pretis, Véronique Lugaz and Mylène Lesénéchal, bioMérieux S.A., Marcy l’Etoile, France

Background & Objectives Hepatitis B Virus (HBV) infection is still a serious global health problem and HBV infection is a leading cause of chronic hepatitis, liver cirrhosis and hepatocellular carcinoma. The qualitative measurement of Hepatitis B surface Antigen (HBsAg) is routinely used for the diagnosis of HBV infection and the screening of blood from donors, whereas the quantitative measurement of HBsAg monitors the progress of chronic hepatitis B, and its rapid decline may be a predictor of the efficacy of the antiviral therapy. However, despite a high sensitivity of the commercial HBsAg assays (0.05 IU/ml using the 2nd WHO standard) there is a continuous need to develop more sensitive assays capable of reducing the window period, detecting occult HBV carriage and monitoring patients receiving innovative treatment concepts that should offer an increased rate of functional cure. SimoaTM (Single Molecule Array) technology provides the ability to measure protein analytes with unprecedented sensitivity, down to the femtomolar range. Quanterix’s HD-1 system offers full automation of Simoa digital immunoassay technology for life science research applications. In this study, a high sensitive quantitative immunoassay for HBsAg was developed as a prototype and analytical as well as clinical usefulness was assessed on the RUO (Research Use Only) system.