A blood donor in Los Angeles has contacted the e-Network Forum wondering if he might once again be eligible to donate. Apparently in 1995 this otherwise healthy individual made a blood donation, but had a positive HCV ELISA screening test. His HCV RIBA was negative. The following tests were also negative: HBsAg, HBcAb, Syphilis serology, HTLV I/II Ab, HIV-I/II Ab. The donor's ALT level was within normal range at the time of the donation (The ALT was 27 International Units, and the upper limit of normal was 50 IU.) No testing for HCV RNA was done at the time of the HCV ELISA screening test. What are colleagues doing presently to re-qualify otherwise healthy donors who have a similar history as the Los Angeles donor who wants to be able to donate again?

The following responses have been received.

ADDENDA June 22, 2004

1. A transfusion medicine physician in Pennsylvania reports that he is not aware of any re-entry protocol for an individual with a repeat reactive HCV antibody screening test.

2. A senior scientist at a research institute in the San Francisco Bay area speculates that the donor under discussion probably had his HCV EIA result obtained using HCV 2.0 EIA since an HCV 3.0 EIA assay was not yet licensed until the summer of 1996. In the January 2000 issue of Transfusion the responding colleague (and several others) published an HCV Lookback article on the use of third-generation hepatitis C virus enzyme immunoassay (HCV 3.0 EIA) to resolve second-generation HCV EIA-reactive recombinant immunoblot assay-indeterminate blood samples. Even though the present situation is not identical, he would not be surprised if a current blood sample from this blood donor would be negative when tested with an HCV 3.0 EIA.

3. A blood banker in California reports that in his opinion the situation described by the inquiring blood donor appears to represent a 'straightforward' anti-HCV donor re-entry, as described in the FDA memo from August 1993, entitled "Revised Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments." Following the re-entry/re-qualification algorithm outlined in that document, the responding colleague's donor center would reinstate this donor as long as the required repeat anti-HCV testing on a current sample was negative. The responding colleague adds that the required repeat anti-HCV testing must be performed by the blood center on a sample collected at least 6 months after the original repeat reactive EIA. He concludes with stating that as some donor centers do not offer re-entry testing for HCV, it might still be best for the donor to contact the donor center that performed the original (repeat reactive) testing.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator