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In Brief: Blood donor screening for HTLV-II

This article was originally published in The Gray Sheet

Executive Summary

Blood donor screening for HTLV-II: FDA should mandate "screening of donor blood for antibodies" to human T-cell lymphotrophic virus type II, the agency's Blood Products Advisory Committee recommends at a Dec. 13 meeting in Bethesda, Maryland. The group also agrees to "permit use of the FDA panel [of reference serum samples] to substantiate claims of HTLV-II detection for kits that contain only HTLV-I antigens." HTLV-I tests could be used for HTLV-II testing during a transition period while labs gear up to use HTLV-II tests, the panel says. FDA called the meeting in anticipation of forthcoming approvals of tests for HTLV-II screening. Abbott Laboratories' combination HTLV-I/HTLV-II enzyme immunoassay, likely to be the first test indicated for HTLV-II screening, is pending at FDA. BioMerieux Vitek subsidiary Cambridge Biotech also has submitted a product licensing application supplement to add the HTLV-II indication to its HTLV-I EIA...
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