In the screening of blood units for Hepatitis B surface Antigen or HBsAg some false positivity may happen, leading to a misinterpretation of the assay results and a misclassification of the blood unit and the donor.
To confirm the positivity of a screened sample or to confirm the presence of an ongoing HBV infection in a hospitalized patient, a confirmatory test has to be run.
A simple procedure based on an immunoreaction of neutralization is used in combination with the HBsAg assay.
The device has to be used in combination with the product code SAG1.CE for the determination of HBsAg in human sera and plasma.