The FDA has granted Siemens’ ADVIA Centaur HIV Ag/Ab combo assay 510(k) marketing clearance, the German devicemaker said Friday.
The assay works by detecting an HIV viral protein and antibodies generated in response to the infection. This ability to detect both antigen and antibody can enable earlier detection of infection and lead to reduced transmission, the company says.
The diagnostic test has been available in European markets since 2010.
Siemens also manufactures assays for hepatitis A,B and C, syphilis and other infectious diseases. — Jason Scott