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The TRUSTwell HBsAg ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HBV. Any reactive specimen with the TRUSTwell HBsAg ELISA Kit must be confirmed with alternative testing method(s) and clinical findings.
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INTRODUCTION
Hepatitis virus B (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 extant 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 polymerase2 , the core antigen (HBcAg)3 and the e antigen (HBeAg)4 . The core of HBV is enclosed in a coat that contains lipid, protein and carbohydrate and expresses an antigen terms hepatitis B surface antigen (HBsAg).
HBsAg is the first marker to appear in the blood in acute hepatitis B, being detected 1 week to 2 months after exposure and 2 weeks to 2 months before the onset of symptoms. Three weeks after the onset of acute hepatitis almost half of the patients will still be positive for HBsAg. In the chronic carrier state, the HBsAg persists for long periods (6-12 months) with no seroconversion to the corresponding antibodies. Therefore, screening for HBsAg is highly desirable for all donors, pregnant women and people in high-risk groups.
STORAGE AND STABILITY
All reagents except the concentrated wash buffer are ready to use as supplied. Return all reagents requiring refrigeration immediately after use. Reseal the microwells after removing the desired number of wells. Ensure that the reagents are brought to room temperature before opening. All the reagents are stable through the expiration date printed on the label if not opened. Do not freeze the kit or expose the kit over 8°C.
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