1. Donations After Reentry
Results of Reentry Processes Based on New 2010 Final FDA Guidelines P Davenport2, L Sutor1, J Chiu2 1University of Texas Southwest Medical Center Dallas, TX and 2Carter BloodCare, Bedford, TX
Background
Methods
Conclusion
Final FDA guidelines for reentering donors deferred for HIV and HCV antibody or nucleic acid tests (NAT) were published in May Under separate, new final guidelines, a process for reentering donors deferred for antibodies to hepatitis B core antigen (anti-HBc) was also published. After implementing these guidelines at our blood center, the results of the new processes over a period of time are presented. These are compared to results from older approved HIV/HCV reentry processes. We also looked at the number of donations the previously deferred donors made after they were reentered to eligible status to assess donor motivation for reentry and to determine whether our efforts were worthwhile.
Contact letters were sent to 288 donors who previously expressed interest in reentry for HIV or HCV, but were not eligible according to older guidelines (indeterminate HIV-1 Western Blot or HCV RIBA) or HIV-1 p24 antigen. A smaller group of donors (72), deferred for more than one positive anti-HBc, was sent contact letters for potential reentry. Donors contacted for anti-HBc reentry were limited to those who had specifically requested reentry testing when available, or had non-sequential repeat reactive (RR) anti-HBc results (non-reactive donations between RR donations). Respondents from both contacted groups and other interested donors deferred for false positive results were tested according to the new guidelines, and records reviewed for eligibility. Donation records of reentered donors were later reviewed to determine donations made after reentry.
Response to the contact letters was surprisingly positive considering that many of the donors had been deferred for 10 years or more. We considered the success rates (eligible for reentry) very positive, especially for HIV reentry, compared to those of an earlier study based on reentry by the old 1992 HIV reentry process. We concluded that the reentry efforts were well worthwhile and that the majority of donors were motivated by desire to resume donating since more than half returned to so, many as repeat donors. Others did not return perhaps because not enough time had passed, or because they may only have wanted the positive result mark removed from their record. Additional data gathered over a longer period of time would yield more conclusive information.
Comparison of Reentry Processes
Reentry Process
Number Tested
Reentered
Denied
2010 HIV 79
75 (94.9 %)) 4
1992 HIV 94
44 (47%) 50
2010 HCV 72
46 (63.9%) 26
1993 HCV
29 (58%) 21
2010 anti-HBc 28
19 (67.8%) 9
Results
References
Of all contact letters sent for potential HIV/HCV/anti-HBc reentry, 35.1% of the donors responded. After all donors were tested by the new guidelines and records reviewed, 94.9% of donors returning for HIV, 63.9% for HCV and 67.8% for anti-HBc reentry were eligible. Lower reentry rates for HCV and anti-HBC were almost entirely due to recurring false positive or repeat reactive results. Within approximately 1 year after the new reentry processes were implemented, 61% of the reentered donors had attempted to donate at least once and 242 whole blood or apheresis products had been collected.
1. FDA Guidance for Industry: Nucleic Acid Testing (NAT) for Human
Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV):
Testing, Product Disposition, and Donor Deferral and Reentry. May 2010.
2. Analysis of the Value of Donor Reentry for False Positive HIV-1/2
Results. K J Land, P Davenport, 2006
3. FDA Memorandum to Blood Establishments: Revised
Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus
Encoded Antigen (Anti-HCV), August 1993
FDA Memorandum to Blood Establishments: Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products. April 1992
Donations After Reentry
Tested
Donors
Reentered Donors
Returned to Donate
After Reentry
Whole Blood/Apheresis Products Collected
Within ~ 1 Year
179
140
86 (61%)
242
Carter BloodCare, AABB 2011