Saturday, 12 September 2015

FDA approves Diagnostic Test to differentiate Between Types of HIV Infection



The U.S. FDA has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay that could differentiate between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens. The assay may be used in adults or children above the age of two years as well as in pregnant women; and may also be used to screen organ donors for HIV-1/2 when the blood specimen is collected while the donor's heart is still beating. However, the agency has not approved the assay for use in screening blood or plasma donors, except in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.

Source: FDA

Posted by Tim Sandle