Use of nucleic acid amplification testing (NAT) results in notification of blood donors to resolve uncertain results for HIV and HCV

A colleague at an academic institution on the West Coast reports that in his institution all HIV and HCV EIA repeat reactive units are discarded and the donors deferred from donating. He says: "The donors are also notified of their results with the final interpretation of either the HIV-1 Western blot or HCV RIBA as well as the band patterns. Included in the notification is an overall interpretation (i.e. true positive = EIA RR + positive confirmatory results, false positive = EIA RR + negative confirmatory results, and the most problematic for the donor, indeterminate = EIA RR + indeterminate confirmatory results). Depending on the rate of indeterminate confirmatory results this can be a very stressful and potentially irresolvable result for a donor to receive. If the donor goes to their personal physician with this result I believe that the physician will tell them that they are not infected but this experience does not leave the donor with a good feeling about blood banks. Many donors I have talked to feel shamed. Therefore, I think the Israel policy is more user friendly on donors with either false positive or indeterminate confirmatory results. The unfortunate consequence of this policy is that the donors do not know that they have been deferred and will continue to donate needlessly, heightening the costs of blood banking. There are many people who believe in the "right to know". I am not one of them. One solution would be to add nucleic acid amplification testing (NAT) results to the notification process, if universal NAT screening is in place. These results would in most instances correctly resolve indeterminate confirmatory results."

The following comments have been received.

ADDENDA Mar. 11, 2004

1. A transfusion medicine physician who works on the East Coast reports that he directed a blood donor service in Israel for 6 years and that he can assure the questioner that the question raised is not geographically unique, but shared by many others. The East Coast colleague says: "The answer, to me, is straightforward. Donors in both scenarios need a PCR/NAT to clarify the blood center's test results concerning their health status. If the blood center could find a way to finance that occasional extra testing, the donor's health status would be defined definitively and messages to their donors would be medically straightforward. If the blood center can't find a way to finance PCR/NAT to resolve their occasional ambiguous test results, then passing the expense of further testing to the patient will require sending confusing messages. If the laboratory budget can't manage the additional cost for PCR/NAT, find it in budgets for recruiting or public relations, because that's where the impact of sending confusion messages to donors will impact."

ADDENDA Mar. 15, 2004

2. A medical director at a blood center in the South informs us that the role of NAT in HIV and HCV confirmation (and hence donor notification) is on the agenda for BPAC this week (March 18). We hope that after this meeting the FDA will issue guidance allowing the use of NAT results in confirmation, and, with luck, in donor reentry algorithms.

ADDENDA Mar. 16, 2004

3. A colleague from a blood center on the East Coast reports that since NAT testing is now licensed, her facility provides both the antibody (EIA and RIBA) results and the NAT results as well as the interpretation of the combination in a single donor notification letter. This allows donors to assess their status correctly. In addition, the FDA requires that any deferred donor be notified of the deferral status. Since donors with HCV RR EIA results are deferred for at least 6 months (assuming NAT and RIBA testing are negative, they would be eligible for reentry testing) they must be notified.

ADDENDA Mar. 24, 2004

4. A physician/lawyer/blood banker reports that in his opinion, blood collection facilities have a clear ethical responsibility to use all readily available testing including NAT to resolve equivocal results on donor tests. He comments that donors have volunteered blood, time and trust and that donors and their private physicians should not be left to their own devices and expense to do these more definitive tests. Ignoring ethics, the reality is also that a blood center, or drawing hospital, is in a much better position to arrange NAT testing, and at a lower actual cost. He concludes with the opinion that the cost should be borne by the donor facility.

ADDENDA Mar. 30, 2004

5. Editor's Note: In followup to response #2 above, the report of the Mar. 18-19 BPAC meeting is now available thru AABB Regulatory Update (March 2004).

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