INTRODUCTION

The Hepatitis B Five Rapid Test kit is a serological, lateral flow chromatographic immunoassay for the qualitative detection of Hepatitis B Surface Antigen (HBsAg), Hepatitis B Surface Antibody (HBsAb), Hepatitis B Envelope Antigen (HBeAg), Hepatitis B Envelope Antibody (HBeAb), and Hepatitis Core Antibody (HBcAb) in human whole blood, serum, or plasma specimens to aid in the diagnosis of infection with hepatitis B virus (HBV). The test only provides preliminary analysis results but not critical diagnosis criteria. Any reactive specimen with the Hepatitis B Five Rapid Test kit must be analyzed and confirmed with alternative testing method(s) and clinical findings. The test is intended for healthcare professional use.

INTENDED USE

Hepatitis B virus (HBV) is the most common cause of persistent viremia and the most important cause of chronic liver disease and hepatocellular carcinoma. Clinically apparent HBV infections may have been in existence for several millennia. It is estimated that there are 300 million chronic carriers of HBV in the world. The carrier rates vary from as little as 0.3% (Western countries) to 20% (Asia, Africa). HBV is a hepatotropic DNA virus. The core of the virus contains a DNA polymerase, the core antigen (HBcAg) and the e antigen (HBeAg). The core of HBV is enclosed in a coat that contains lipid, carbohydrate and protein including an antigen termed hepatitis B surface antigen (HBsAg). Most people fight off the infection themselves, but approximately 5-10 percent of those infected with the virus become carriers, and an additional 5-10 percent of those infected each year will progress to chronic liver disease, cirrhosis and possibly liver cancer.

The Hepatitis B Five Rapid Test kit utilizes specific antigens and antibodies to detect the presence of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb qualitatively in human whole blood, serum, or plasma specimens. This assay can be performed to get test result at 15-20 minutes by minimally trained personnel and without cumbersome laboratory equipment.