FDA has recently granted premarket approval (PMA) to Siemens Healthcare Diagnostics for the company’s HIV Ag/Ab combo assay for use on the Advia Centaur immunoassay analyzer.
The Advia Centaur HIV Ag/Ab combo assay simultaneously detects the presence of the HIV viral protein (p24 antigen) and the antibodies produced in response to infection with either HIV-1 or HIV-2.1 The test’s ability to detect both the antigen and the antibody may make it possible to detect acute infection earlier, facilitating both clinical management and behavior modification that can reduce transmission.
“Siemens continues to invest in the development of new solutions that allow clinical laboratories to improve both patient care and workflow efficiency,” says Franz Walt, CEO of the chemistry, immunoassay, automation, and diagnostics IT business unit at Siemens Healthcare Diagnostics. “We are proud to offer our US customers a broad range of high-performance, fully automated infectious disease tests, which now includes the Advia Centaur HIV Ag/Ab combo assay.”
The newly approved assay joins an extensive menu of infectious disease tests performed on the Advia Centaur, including tests for hepatitis A, B, and C; eHIV; syphilis; and other infectious diseases. Its addition to the Advia Centaur menu will enable laboratories using the analyzer to further enhance efficiencies by consolidating their testing onto the platform.
The Advia Centaur HIV Ag/Ab combo assay is intended for use as an aid in the diagnosis of both acute and established HIV-1 and HIV-2 infection (including HIV-1 group O infection). A fourth-generation HIV assay, the test has been available in Europe since 2010. The company’s third-generation enhanced HIV test (eHIV) will also remain available for use on Advia Centaur systems.
For further information, visit Siemens Healthcare Diagnostics.