Infection Disease Hepatitis B HbsAg Rapid Test Device

For professional in vitro diagnostic use only

INTENDED USE

The HBsAg Rapid Test Strip (Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.

INTRODUCTION

Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. In the lipid envelope of this small DNA virus the hepatitis B surface antigen (HBsAg) is located. During the replicative phase of the virus this surface antigen is produced in excess and detectable in the blood of infected person. The antigens HBcAg and HBeAg are parts of the nucleocapsid. The incubation period of HBV is 6 weeks to 6 months.

PRINCIPLE

The HBsAg Rapid Test Strip (Serum/Plasma) has been designed to detect the HBsAg through visual interpretation of color development in the strip. The membrane was immobilized with anti-HBsAg antibodies on the test region. During the test, the specimen is allowed to react with colored anti-HBsAg antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough HBsAg in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products.

With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of abuse, our research and development team continues to grow.

Based in Hangzhou, the company has long-term cooperation with various R&D institutions in greater China, the United States and Europe, offering the strongest technical support for the development of the company.

We are also a certified ISO and CE organization. By employing strict quality control system, our management team assures exceptional customer service and high quality products.