98-28219. Antibody to Human T-Cell Lymphotropic Virus Type II (HTLV-II) Reference Panel 1; Availability

[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.

-----------------------------------------------------------------------

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

[[Page 56198]]

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