INTENDED USE
THE ADVANCED QUALITY™ ONE STEP HBEAG TEST IS A RAPID, ONE STEP, IMMUNOCHRO-MATOGRAPHIC ASSAY FOR THE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM. THE TEST PROVIDES A VISUAL, QUALITATIVE RESULT, AND IS INTENDED FOR PROFESSIONAL USE.
SUMMARY AND PRINCIPLE OF THE ASSAY
The One Step HBeAg Test is a colloidal gold enhanced immunoassay for the determination of HBeAg in human serum. The nitrocellulose membrane was immobilized with mouse anti-HBeAg McAb on the test region. During the assay the serum specimen is allowed to react with the colored conjugate(antibodycolloidal gold conjugate); the mixture then migrate chromatographically on the membrane by the capillary action. For a positive result, a color band with the specific antibody-HBeAg-colored conjugate complex will form on the membrane. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at control region always appears.
STORAGE CONDITIONS
The test kits must be stored at 2-30ć in the sealed pouch and under dry conditions.
PRECAUTIONS
It is recommended that all specimens be handled in accordance with Biosafety Level 2 practices as described in the CDC NIH Publication, Biosafety in Microbiological and Biomedical Laboratories1 or other equivalent guidelines.2-3