Siemens Healthcare Diagnostics, a global leader in vitro diagnostics, recently submitted a pre-market approval application to the Food and Drug Administration (FDA) for its HIV combo assay, ADVIA Centaur HIV Ag/Ab. This assay is designed to simultaneously detect the presence of the HIV p24 antigen and antibodies to HIV Type 1, including Group O (HIV-1 + “O”) and/or Type 2 (HIV-2) in serum and plasma, which could allow for earlier detection of HIV infection than antibody tests. This combo assay is for use on the ADVIA Centaur® and ADVIA Centaur® XP Immunoassay Systems by Siemens Healthcare Diagnostics, which currently offer a complete HIV screening test menu to clinical laboratories in Europe.
According to CDC, the Centers for Disease Control and Prevention, an estimated 1.1 million people are living with HIV in the United States. The HIV-1 and HIV-2 antibodies bind to the HIV protein soon after infection, hiding the presence of infection and making it difficult to diagnose. The ability of Siemens’ combo assay to detect both the antigen and the responding antibodies simultaneously increases the likelihood of early detection and treatment for HIV patients. Diagnosing HIV infection early allows a person to make more informed decisions.
Siemens’ ADVIA immunoassay system offers comprehensive diagnostic testing, covering screening, diagnosis, risk assessment and monitoring. It can hold up to 180 samples as well as up to 30 reagent packs and its dedicated STAT capabilities maximize productivity, regardless of volume or type of test. It comes with advanced features such as the Smart Algorithm Software that automatically repeats and confirms reactive testing, disposable pipette tips that eliminate sample-to-sample carryover, and high-resolution touch screen for easy interaction.
Dave Hickey, Executive Vice President, Central Laboratory and Global Product Development at Siemens Healthcare Diagnostics said, “Siemens continues to invest in the development of new tests that allow clinical laboratories to reduce costs, while enhancing the quality and timeliness of patient care. The introduction of the ADVIA Centaur HIV Ag/Ab combo assay is an example of our commitment to offer customers a broad range of high performance, fully automated HIV screening tests”.