The Determine HBsAg is an in Vitro, visually read, qualitative immunoassay for the detection of Hepatitis B Surface Antigen (HBsAg) in human serum, plasma or whole blood. The test is intended as an aid to detect HBsAg from infected individuals.
SUMMARY AND EXPLANATION OF THE TEST Assays for HBsAg are used to screen blood and blood products for the presence of HBsAg to prevent transmission of hepatitis B virus (HBV) to recipients of these products. HBsAg assays are also routinely used to diagnose suspected HBV infection and to monitor the status of infected individuals;i.e.,whether the patient's infection has resolved or the patient has become a chronic carrier of the virus.
BIOLOGICAL PRINCIPLES OF THE PROCEDURE Determine HBsAg is an immunochromatographic test for the qualitative detection of Hepatitis B Surface Antigen (HBsAg).
Sample is added to the sample pad. As the sample migrates through the conjugate pad, it reconstitutes and mixes with the selenium colloid-antibody conjugate. This mixture continues to migrate through the solid phase to the immobilized antibodies at the patient window site.
If HBsAg is present in the sample, the antigen binds to the antibody-selenium colloid and to the antibody at the patient window, forming a red line at the patient window site.
If HBsAg is absent, the antibody-selenium colloid flows past the patient window and no red line is formed at the patient window site.
To insure assay validity, a procedural control bar is incorporated in the assay device.
HBsAg is an in Vitro, visually read, qualitative immunoassay for the detection of Hepatitis B Surface Antigen (HBsAg) in human serum, plasma or whole blood. The test is intended as an aid to detect HBsAg from infected individuals. 
