IVD Department Qualitative HBsAg Test - Vietnam Registration 2300650ĐKLH/BYT-HTTB

- ADVIA Centaur HBsII: The ADVIA Centaur HBsAgII (HBsII) test is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (containing EDTA, lithium heparin, sodium heparin and citrate). The test can be used in combination with other serum and clinical information to diagnose individuals (infants, children, teenagers, adults) with acute or chronic hepatitis B. The test can be used to screen for hepatitis B infection in pregnant women to determine the risk of transmission of hepatitis B to the fetus during the perinatal period. The test can be used to screen blood donors or recipients of blood products intended for transfusion or further processing, or to screen individuals who will receive transplanted cells, tissues and organs. Specimens can be obtained from the beating heart of the donor or from the donor's body (heart no longer beating). - ADVIA Centaur HBsAg Conf: The ADVIA Centaur HBsAg Confirmatory (Conf) test is an in vitro diagnostic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (containing EDTA, lithium heparin, sodium heparin and citrate) using the ADVIA Centaur CP, ADVIA Centaur XP and ADVIA Centaur XPT systems. The test is used in individuals (infants, children, teenagers and adults) to confirm the presence of HBsAg in samples that reacted repeatedly positive when tested with the ADVIA Centaur HBsAgII (HBsII) test. Specimens can be obtained from the beating heart of the donor or from the donor's body (heart no longer beating). - ADVIA Centaur HBsAg QC: To monitor the performance of the ADVIA Centaur HBsAg, HBsAgII and HBsAg Confirmatory tests on the ADVIA Centaur systems. The performance of the ADVIA Centaur HBsAg control material has not been established for any other HBsAg or HBsAg Confirmatory test.