10.5 Reinstatement of donors
Reinstatement of donors (see Figure 10.2) whose serum has been confirmed to be falsely reactive in a microbiology assay.
Where an initial sample taken at donation, and tested at a blood centre, is found repeatedly reactive (RR), materials from that donation must not be used for transfusion, the donor's record must be flagged in accordance with standard operating procedures and the donor removed from the active panel. No further material from the donor must be used for clinical purposes until the donor has been returned to the active panel.
A specimen of the RR sample must be sent for confirmatory testing at a designated reference laboratory. If the specimen is considered to have been falsely reactive, reinstatement may be considered after a period of follow-up. At least 12 weeks must elapse from the date of the first sample before the donor can be retested for consideration for reinstatement.
The specimen, taken at least 12 weeks after the initial bleed, must be sent to a designated reference laboratory. A number of options exist for reinstatement to the active panel depending upon the results of testing the 12-week follow-up sample at the blood centre and the designated reference laboratory. These are:
sample now non-reactive in the current screening assay at the blood centre, and confirmed negative at the designated reference laboratory. Action – return to active panel as eligible for future donations. The next donation may be used if a negative result is obtained in the current screening test
Figure 10.2 Action chart - donor reinstatement
sample now non-reactive in the current screening assay at the blood centre, discordantly reactive but considered falsely so at the designated reference laboratory. Action – return to active panel as eligible for future donations. The next donation may be used if a negative result is obtained in the current screening test
sample still reactive in the current screening assay used at the blood centre, but non-reactive in an alternative assay at blood centre and either non-reactive or discordantly reactive but considered falsely so at the designated reference laboratory. Action – return to active panel as eligible for future donations if negative on an alternative screening test screening test (see next paragraph and Figure 10.2).
In order to reinstate a donor whose serum/plasma remains falsely reactive in the original screening test, the blood centre must run a different assay either as routine practice or as a specific screen for flagged donors whose sera previously have been shown to give a false reaction in one particular assay. The following conditions must be met for this to be acceptable:
at least 12 weeks must elapse between the date of the first RR sample and the follow up sample tested in the alternative assay
the alternative assay must be of equivalent sensitivity to the first assay in which the original serum/plasma gave a repeatable reaction and conform to requirements of microbiology tests, see bullet point two above
the designated reference laboratory must have confirmed the false nature of the serum/plasma reactivity on a sample taken at least 12 weeks after the index donation
where archival samples are held on a donor, the blood centre may adopt the strategy of testing samples taken at least 12 weeks, but not exceeding 12 months, apart in the alternative assay in order to fulfil the criteria retrospectively
donations taken subsequent to the return of the donor to the active panel may be used provided that the donation is non-reactive by the alternative assay. The donor's record must remain flagged with the information identifying previous false reactivity for the marker.
Specific requirements for HBsAg
The designated reference laboratory must, as a minimum, perform specific neutralization tests for HBsAg and determine the anti-HBc status. Samples containing neutralizable HBsAg, with or without anti-HBc, indicate infection with HBV (except in cases where this may be due to recent immunization with HBsAg). Anti-HBc IgM may be useful in identifying a recent infection. Donors whose samples are falsely reactive for HBsAg but which contain anti-HBc cannot be considered for reinstatement unless anti-HBs is also present, or has previously been documented, at more than 100 IU/L.