Re-entry of donors who tested positive in an HCV ELISA antibody screen but RIBA-negative, prior to implementation of HCV-RNA testing

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.

4. A repeat blood donor requests updated information regarding possible re-entry as a qualified blood donor after deferral from donation because of false positive screening tests for HCV infection. The prospective donor writes: "A long time ago I was a dedicated blood donor, donating blood every two months for years on-end. At some point I was sent a letter that indicated a donation of mine had been screened for HCV and some kind of red flag had been raised. With this red flag, they tested further with a battery of tests - three or four - and all but one came back negative. The letter indicated that this cumulative result was likely a false positive, but that I should get re-tested through my personal doctor and that I would (might?) be permanently deferred from donating blood. My first question is: I don't remember if the letter said that I would be deferred, or if I just imagined this after subsequent conversations with blood donation professionals. Is there a master deferment list somewhere, and someone I can talk to about it? ...or is deferment instituted on a center-by-center basis? Secondly: assuming I am permanently deferred from donating anywhere ever... Knowing that that was a false positive, which was supported by the tests my physician did, how do I begin donating again? I've spent a lot of time searching for answers on this question, and there does not appear to be a concensus. I've talked to people who said there are no re-entry programs for HCV at this time (this was several years ago), and just this morning I found this draft from the FDA, which appears to recommend such programs should exist. All I want is to be able to donate again. I am a strong, healthy, young man with something to give, and I think its a shame that I would be barred from helping others where there is no real risk."

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

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

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator