USE OF LICENSED HTLV-1 TESTS FOR HTLV-2 SCREENING ACCEPTABLE IF ADEQUATE SENSITIVITY SHOWN ON FDA-DEVELOPED HTLV-2 SAMPLE PANEL, BPAC PANEL SAYS
This article was originally published in The Gray Sheet
Executive SummaryUse of licensed human t-cell lymphotrophic virus type I screening tests for HTLV type II blood donor screening should be permitted by FDA if the in vitro diagnostic shows adequate sensitivity to an agency-developed HTLV type II sample panel, FDA's Blood Products Advisory Committee recommended at a Dec. 13 meeting in Bethesda, Maryland. The recommendation followed a unanimous 15-0 vote advising FDA to mandate HTLV-II screening of donor blood.
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