Siemens is now making the Siemens Healthcare Enzygnost HIV Integral 4 assay, an HIV test mainly intended for use in blood banks or laboratories in Europe. (It is not currently available in the United States.) The new assay is an HIV Combo test, a type of assay that detects both the HIV p24 antigen and HIV antibodies. This type of test is increasingly becoming the standard screening technique used by healthcare authorities in many countries within the European Union. It is designed to deliver accurate results quickly and reliably and enable clinicians to identify HIV infection earlier.
In a study of 14,169 donor samples tested at three blood banks, initial specificity was demonstrated at 99.94%. 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,” says 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 confidence that the results are precise, enhancing the accuracy of donor screening programs.” Learn more about Siemens infectious disease testing.