HBsAg assays are routinely used to aid in the diagnosis of suspected hepatitis B viral (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. For the diagnosis of acute or chronic hepatitis, HBsAg reactivity should be correlated with patient history and the presence of other hepatitis B serological markers. Samples nonreactive by ARCHITECT HBsAg are considered negative for HBsAg and need not be tested further. A reactive sample must be retested in duplicate by ARCHITECT HBsAg to determine whether it is repeatedly reactive. A sample which is found to be repeatedly reactive should be confirmed by a neutralizing confirmatory test utilizing human anti-HBs, such as the ARCHITECT HBsAg Confirmatory assay. If the sample is neutralized, the sample is considered positive for HBsAg. It is recommended that confirmatory testing be performed prior to disclosure of HBV status.
Manufacturer’s reagent package insert, Architect HBsAg, June 2015, Abbott Ireland Diagnostics Division, Finisklin Business Park, Sligo, Ireland.