FDA approves first NAT test to screen for HIV and HCV

     The Food and Drug Administration has licensed the first nucleic acid test (NAT) system to screen donors of whole blood and blood components intended for use in transfusion.  The test system can simultaneously detect the presence of HIV and HCV in blood using a semi-automated system and is expected to further ensure the safety of whole blood and blood components, including fresh plasma, red cells and platelets, by permitting earliest detection of HIV and HCV infections in donors.

     Also recently licensed by the FDA, the first NAT system for screening donors of plasma for the specific use in products that will be further manufactured, such as clotting factors and immune globulins.

     The test system was developed by Gen-Probe Inc., San Diego, Calif. and will be distributed by Chiron Corporation of Emeryville, Calif.