The GB HBsAg ELISA kit (SURASE B-96) for detecting Hepatitis B surface antigen calculates intra-assay CVs ranging between 3.7% and 11.36%, and inter-assay CVs between 30.4% for an HBsAg negative sample and 23.1% for an HBsAg low positive sample. The kit with 96 tests and a shelf life of 18 months is CE marked and TFDA certified, and also fulfills the new Common Technical Specifications (CTS) of the European IVD Directive (2009 / 108 / EC).