Intended use
The Aurora V-Panel is intended for the qualitative detection of HIV 1/2 antibodies, Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies (anti-HCV), and Treponema pallidum antibodies (anti-TP) in human serum or plasma. This chemiluminescence immunoassay (CLIA) panel is designed for in vitro diagnostic use, and is primarily intended to support visa medical examinations, routine screening, and infectious disease diagnostics on compatible automated analyzers.
Principle
The AURORA V-Panel assays are two-step chemiluminescent immunoassays (CLIA) designed for the qualitative detection of specific antigens or antibodies related to HIV, Hepatitis B (HBsAg), Hepatitis C (HCV Ab), and Treponema pallidum (TP Ab) in human serum or plasma. In the first step, magnetic particles coated with specific recombinant antigens or antibodies capture the target analyte. In the second step, the labeled conjugates bind to form immune complexes. The resulting chemiluminescent signal, measured in relative light units (RLUs), is directly proportional to the presence of the target antigen or antibody in the specimen.
Storage
All reagents in the AURORA V-Panel should be stored at 2°C to 8°C and must not be frozen. Keep the reagents in their original, sealed packaging until ready for use to avoid contamination or degradation. Do not use the kit beyond the expiration date indicated on the label. Once opened, reagents should be handled according to standard laboratory procedures to maintain stability and reliability of results.