Abbott Labs has announced CE Marking of its new ARCHITECT HBsAg Qualitative II assay for diagnosis of hepatitis B. Like existing Hep B tests, the new assay detects hepatitis B surface antigen (HBsAg) to aid in diagnosis of acute or inactive chronic carrier phase of the infection.
Abbott claims that its new test can also detect HBsAg mutants and is more sensitive than existing tests, which allows for diagnosis of patients who have been infected with a mutant strain of the virus and those with particularly low HBsAg levels.
From the press release:
The ARCHITECT HBsAg Qualitative II assay is intended to be used as an aid in the diagnosis of HBV infection and as a screening test for donated blood and plasma using the ARCHITECT immunochemistry system. It provides qualitative detection of HBsAg, which is the first serological marker after infection with HBV and appears in the blood between one to 10 weeks after exposure to the virus.
The ARCHITECT HBsAg Qualitative II test is a chemiluminescent microparticle immunoassay (CMIA) that offers seroconversion sensitivity for low-volume testing sites that is equivalent to the high-volume HBsAg blood screening assay performed on Abbott’s PRISM system. The analytical sensitivity of the ARCHITECT assay is 0.017 to 0.022 IU/mL, and the specificity on samples from overall blood donors (serum and plasma) is 99.91 percent. Abbott also has a CE-marked ARCHITECT confirmatory test for samples found repeatedly reactive on the HBsAg Qualitative II assay.
Press release: Abbott Receives CE Mark for New Hepatitis Test