Unlicensed Anti-HCV Supplemental Test Results (8/19/93)

Date:     August 19, 1993

From:     Acting Director, Office of Blood Research and Review,
          Center for Biologics Evaluation and Research

Subject:  Clarification of the Use of Unlicensed Anti-HCV
          Supplemental Test Results in Regard to Donor
          Notification

To:       All Registered Blood and Plasma Establishments

This memorandum transmits a clarification to the Revised
Recommendations for Testing for Antibody to Hepatitis C Virus
Encoded Antigen (Anti-HCV) in Blood Establishments, August 5,
1993, in regard to donor notification (Section I.A.3.c., page
3a).

A donor who was tested with an unlicensed anti-HCV supplemental
test prior to August 5, 1993, may be notified of those results
providing certain statements are included in the notification.
This notification should state that such results have been
generated from a test which was unlicensed, but similar in
principle, to the currently licensed supplemental test and that
if the donor's physician has concerns regarding the accuracy of
such results, repeat testing using the licensed test could be
considered.

After August 5, 1993, for donor notification (beyond test results
obtained with a licensed ELISA), tests on donors who are
repeatedly reactive by ELISA should be performed with licensed
anti-HCV supplemental tests.

Only licensed supplemental tests should be used for attempting
donor re-entry.


                            Jay S. Epstein, M.D.