Notification of donors who test HIV and/or HCV ELISA positive but confirmatory testing is indeterminate or negative
A colleague in Israel is interested to learn how others handle the following two donor testing scenarios for HCV and HIV in terms of donor product disqualification and donor notification:
- ELISA: positive, confirmatory test: indeterminate
- ELISA: positive, confirmatory test: negative
The Israeli colleague recognizes that the approach taken in each of the above situations may depend on local considerations, such as 'country specific' regulations. With that consideration in mind he asks for each scenario:
- Should donors be informed of test results and referred to their physician for further assessment/follow up?
- Should the donors be requested not to donate in the future since ELISA positive blood will not be acceptable for transfusion?
The Israeli colleague comments that according to the Israeli Ministry of Health regulations, repeat reactive ELISA units are not fit for transfusion, but that only donors with POSITIVE confirmatory tests are notified. He is concerned that the disparity between donor notification and donated blood product disqualification criteria create potential "internal conflicts of logic" or apparent double standards, vis-a-vis a donor is not told about their 'ELISA only' positivity because that unconfirmed result is not considered medically significant, yet a recipient is not transfused with a blood product whose donor was 'ELISA only' positive. How do others handle these issues?
The following comments have been received.
ADDENDA Mar. 12, 2004
- A colleague in the Pacific Northwest reports that the policy at their blood collection center is to notify all donors who test repeat reactive in HIV and/or HCV ELISA screening tests, even if the confirmatory testing is indeterminate or negative. Their exact procedure is as follows:
Notification: All donors are notified of deferrals for testing, regardless of the confirmatory testing. They are told the results of the confirmatory testing, and advised to consult with their physician.
HIV: Donor is indefinitely deferred regardless of confirmatory testing results. In the particular state in which this donor collection center is located, HIV testing results must be communicated face-to-face in conjunction with counseling. ELISA-reactive donors are sent a letter requesting an appointment with a counselor. Test results are not sent with the letter, but given to the donor at the time of the appointment. The counseling program is tailored to the results of the confirmatory testing.
HCV: If the confirmatory test is negative, the donor is sent notification of the results and informed they are eligible for retesting in 6 months. At that time a blood sample is drawn for ELISA testing. The ELISA result must be negative for the donor to be re-entered. If a second ELISA test is ever reactive, no re-entry is possible and the donor is permanently deferred. Donors with indeterminate or positive confirmatory test results are indefinitely deferred.
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