[Federal Register Volume 63, Number 203 (Wednesday, October 21, 1998)] [Notices] [Pages 56197-56198] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-28219] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Antibody to Human T-Cell Lymphotropic Virus Type II (HTLV-II) Reference Panel 1; Availability
Agency
Food and Drug Administration, HHS.
Action
Notice.
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Summary
The Food and Drug Administration (FDA) is announcing the availability of a new FDA reference panel for tests intended to detect antibody to human T-cell lymphotropic virus Type II (HTLV-II Reference Panel 1). The HTLV-II Reference Panel 1 is used for the qualitative and semiquantitative evaluation of in vitro tests to detect antibody to HTLV-II in human serum or plasma. The HTLV-II Reference Panel 1 is designed to provide a release criterion for lots of HTLV-II antibody detection kits produced by licensed manufacturers of such tests and should not be used for experimental or other reference purposes.
Dates
The HTLV-II Reference Panel 1 was made available to the licensed manufacturers on June 4, 1998.
For Further Information Contact
Charles O. Roberts, Center for Biologics Evaluation and Research (HFM-323), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594- 6721.
Supplementary Information
The HTLV-II Reference Panel 1 is a regulatory test panel intended for lot release testing of enzyme-linked immunosorbent assay (ELISA) HTLV-II antibody test kits produced by licensed manufacturers. The HTLV-II Reference Panel 1 consists of eight samples, six of which are reactive for antibody to HTLV-II. These reactive sera have been prepared by diluting known positive sera into a pool of normal human sera negative for antibodies to HTLV-II. Three of the diluted samples are expected to be repeatedly reactive for antibodies to HTLV-II by ELISA and three have borderline ELISA reactivity. The Center for Biologics Evaluation and
Research will limit the distribution of the HTLV-II Reference Panel 1 to conserve these reagents when necessary. The HTLV-II Reference Panel 1 is available for distribution from the contact person listed above.
Dated: October 9, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-28219 Filed 10-20-98; 8:45 am] BILLING CODE 4160-01-F