Disp. of blood for autologous use - reactive for Anti-HCV

Date:     September 11, 1991

From:     Acting Director, Center for Biologics Evaluation and
          Research :

Subject:  Disposition of Blood Products Intended for Autologous -
          Use That Test Repeatedly Reactive for Anti-HCV

To:       All Registered Blood Establishments

This clarification responds to numerous questions that have
arisen concerning FDA's recommendation for handling autologous
blood products collected from anti-HCV reactive donors. FDA
believes that public health considerations dictate the need for
caution in the distribution and autologous use of anti-HCV
reactive products. Accordingly, when the test for anti-HCV is
repeatedly reactive, the blood product should be permanently
labeled with the "Autologous use only" and special BIOHAZARD
labels described in the current Guideline for the Uniform
Labeling of Blood and Blood Components. The Circular of
Information distributed with blood products should include
appropriate explanation concerning use of the biohazard label 
when an autologous unit tests repeatedly reactive for anti-HCV.

Currently available screening tests for anti-HCV may be falsely
positive, and FDA licensed more specific tests are not yet
available. Additionally, the available tests may fail to detect
HCV infection in a significant proportion of cases. It is
appropriate, therefore, to make autologous units available
regardless of the anti-HCV test results. The patient's physician
should be informed of the repeatedly reactive test results, but
it is not necessary to obtain written documentation of the
physician's concurrence as outlined in the FDA's memorandum of
March 15, 1989, for autologous use of HBsAg reactive or anti
HIV-1 positive blood products. Autologous donors with repeatedly
reactive screening tests for anti-HCV should be indefinitely 
deferred from donating blood for homologous use. In addition,
autologous donors testing repeatedly reactive for anti-HIV-1,
HBsAg, or anti-HTLV-I, should be deferred from donating blood for
homologous use, unless and until the donors are reentered
consistent with the guidance in FDA memoranda of 2 December 1987
(HBsAg), 29 November 1988 (anti HTLV-I), and 5 February 1990 and
5 December 1990 (anti-HIV-1).


                     Gerald V. Quinnan, Jr., M.D.