Antibody to Human T-Lymphotropic Virus Type I (HTLV-I) Reference Panel 3; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a new FDA reference panel for tests intended to detect antibodies to Human T-Lymphotropic Virus Type I (HTLV-I Reference Panel 3). HTLV-I Reference Panel 3 is a regulatory test panel intended for lot release testing of enzyme-linked immunosorbent assay (ELISA) HTLV-I antibody test kits. The HTLV-I Reference Panel 3 is intended to replace HTLV-I Reference Panel 2F. FDA recommends that manufacturers of currently licensed HTLV-I test kits supplement their approved product license applications by amending their lot release protocols to use the HTLV-I Reference Panel 3.