This new assay is an HIV combination test (or HIV Combo test), a type of assay that detects both the HIV p24 antigen and HIV antibodies, and is increasingly becoming the standard screening technique used by healthcare authorities in many countries within the European Union. The development of the new HIV assay demonstrates the company’s innovative power, one of the goals of Siemens Healthcare Initiative “Agenda 2013”.
The Enzygnost HIV Integral 4 assay delivers both excellent specificity and sensitivity. In a study of 14,169 donor samples tested at three different blood banks, initial specificity was demonstrated at 99.94 percent. Data also show that the HIV Integral 4 assay has higher sensitivity and provides superior seroconversion performance (quicker prevalence of the antibody) compared to other currently available assays, detecting HIV infection up to 14 days earlier.
“Reliable and accurate testing technologies are critical to supporting HIV infection control and optimal patient management,” said Stefan Wolf, CEO, Hemostasis, Hematology and Specialty Business Unit, Siemens Healthcare, Diagnostics Division. "The increased sensitivity of the HIV Integral 4 assay enables clinicians to detect disease and initiate treatment earlier, and its high specificity provides our blood bank customers with confidence that the results are precise, enhancing the accuracy of their donor screening programs.”
The new assay is available on the Siemens laboratory systems Quadriga BeFree and BEP.
Launched in November 2011, “Agenda 2013” is an initiative of the Siemens Healthcare Sector to further strengthen its innovative power and competitiveness. Specific measures, which will be implemented by the end of 2013, have been defined in four fields of action: innovation, competitiveness, regional footprint, and people development.
1. The products/features (here mentioned) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Further details are available from the local Siemens organizations. Not available for sale in the United States.
Photograph Caption: Quadriga BeFree® System for use with Enzygnost®Assays (ELISA)