Background/Case Studies: FDA guidance outlines reentry pathways for donors deferred due to reactivity on serologic and/or nucleic acid tests (NAT) for relevant transfusion-transmitted infections. Most pathways require donors to have negative results on specified tests after a defined waiting period. We evaluated the characteristics of American Red Cross (ARC) blood donors reinstated through the reentry program due to false-positive test results.
Study
Design/Methods: Blood donors who provided a follow-up sample for reentry between January 1, 2010, and December 31, 2024, and blood donations collected during the same period were analyzed. The frequency of returning to donate and median inter-donation interval among reentered repeat (RRP) donors who donated after reinstatement and never-deferred repeat (NDRP) donors were determined. The probability of returning to donate was measured between the time of the first two donations collected from each donor during the study period and evaluated using the cumulative incidence function (CIF). CIFs were compared using Gray’s test.
Results/Findings: During the study period, 25,323 ARC blood donors provided a follow-up sample, and 25,119 (99.2%) were tested, while 204 (0.8%) were deemed unsuitable. Of the tested donors, 19,915 (79%) tested negative and qualified for reinstatement, while 5,204 (21%) tested reactive for at least one test (Table 1). Table 1 shows the number of samples tested via NAT and serology combined for each marker and the rates of non-reactivity. By the end of the study period, 16,375 RRP donors (82%) had returned to donate, providing a cumulative 192,496 donations, including 16,097 power reds, 13,755 platelets/plasma, 524 plasma, 32,488 platelets, and 129,579 whole blood units. Most donors were ≥40 years old at the time of reentry (78%) and white (89%), while sex was equally distributed. The most represented blood type in reentered donors was O+ (41%), and 44% of the donors had previously provided ≥10 donations.
By the end of the study period, RRP donors had a higher probability of providing at least two donations (~89%) compared to NDRP donors (71%; p< 0.0001). Overall, RRP donors had a shorter inter-donation median time interval (69 days; range: 56-123) compared to NDRP donors (112 days; range: 63-213) and donated more frequently (average donation frequency: 2.8 donations/year for RRP vs 2.1 donations/year for NDRP donors).
Conclusions: Blood donors deferred due to false-positive test results who consent to donate a follow-up sample for the purpose of reentry are significantly more likely to donate and at a higher frequency than repeat donors who are never deferred. The blood donor reentry program is a valuable tool to reengage motivated blood donors.
