STN: 125674
Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgG and IgM) and Antibody to Hepatitis B Surface Antigen (Sheep)
Tradename: Alinity s HBsAg and Alinity s HBsAg Confirmatory
Manufacturer: Abbott Ireland Diagnostics Division.
Indication:
- The Alinity s HBsAg Confirmatory assay is used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization on the Alinity s System. The assay is intended to be used for confirmation of samples found to be repeatedly reactive by the Alinity s HBsAg assay.
- The Alinity s HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. The Alinity s HBsAg assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
Product Information
Supporting Documents
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Content current as of:
03/10/2026
