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MEMORANDUM

Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) Memorandum to Registered Blood and Plasma Establishments May 1996

Final
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

On April 23, 1992, August 5, 1993, and August 19, 1993, FDA issued memoranda to all registered blood and plasma establishments, which provided recommendations for testing for antibody to Hepatitis C Virus Encoded Antigen (anti-HCV). This memorandum supplements those previous memoranda by transmitting additional recommendations for testing for antibody to anti-HCV in blood establishments. (See attached recommendations.)

In a public meeting of the Blood Products Advisory Committee (BPAC) on March 21, 1996, after review and discussion of the relevant information available, concern was expressed that the use of a supplemental test for anti-HCV that uses fewer antigens than the screening test for anti-HCV may cause uncertainties. In particular, the Committee discussed its concern that the use of the Chiron RIBA HCV 2.0 Immunoblot Assay (SIA) as a supplemental test for anti-HCV should not be used for donor re-entry if the Ortho™ HCV Version 3.0 ELISA Test System was used as a screening test. FDA has considered the BPAC concerns and sets forth in the attached recommendations donor re-entry and counseling procedures that should be used in this situation.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
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