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Abstract

Blood Center/Blood Hospital-Based Donor Center

Plenary Oral Abstract Session

PL6-SN-27 - Implementation of Individual Donor Assessment in the USA and Impact on Rates of Residual Infectious Disease

Sunday, October 20, 2024
9:30 AM - 11:00 AM  
CE: Zero

    Presenting Author(s)

  • Mary Townsend, MD (she/her/hers)

    Vice President, Corporate Medical Director
    Vitalant
    Scottsdale, Arizona, United States

    Disclosure(s): No financial relationships to disclose

    PDF
Disclosure(s):
Mary Townsend, MD: No financial relationships to disclose
Background/Case Studies: In 2023, US FDA introduced new guidelines for implementation of individual donor assessment (IDA) based upon known HIV risk behaviors rather than previous time-based, gender-specific deferrals of specific donor groups. We report deferral rates overall and by sex since IDA implementation and compared infectious disease marker (IDM) rates pre- and post-IDA implementation.

Study

Design/Methods:

Post-IDA allogeneic donor responses 8/20/2023 to 3/31/2024 were analyzed. IDA asked if donors had either a ‘new’ sexual partner or ‘multiple’ sex partners in the past 3 months and if so, if they had anal sex.  Response proportions per interview and per unique donor, also stratified by sex, were reported. We compared confirmed-positive IDM rates for HIV, HBV and syphilis in identical months (2 years’ data) under IDA vs. previous 3-month MSM-based deferrals.

Results/Findings:

A total of 810,828 interviews of 487,836 unique donors were conducted post-IDA. In 1.2% of interviews (9493), donors responded yes to sex with a new partner in the past 3 months. In 3.7% (346/9493) there was a yes response to anal sex, a 0.04% deferral rate. Of all interviews, 0.6% (4674) had yes responses to sex with >1 partner in the past 3 months, of which 4.8% (215/4674) also had a yes response to anal sex, a 0.03% deferral rate. Due to overlapping yes answers, in total, 0.05% (439) of interviews resulted in deferrals involving 0.09% (437) of unique donors.

By sex, 2.13% of female and 2.08% of male unique donors reported yes to either new or multiple sex partners in the past 3 months. Further, 0.08% of female and 0.10% of male respondents reported yes to anal sex and were deferred. Sex-specific deferral rates were not statistically significantly different (p= 0.10).

IDM analysis: Confirmed HIV and HBV rates pre- and post-IDA were similar at 0.19 versus 0.23 per 10K donations (p=0.58) and 0.69 versus 0.61 per 10K (p=0.53), respectively.  Confirmed syphilis rates accompanied by a reactive RPR (active or recently treated infection) pre- and post-IDA were similar at 1.46 versus 1.81 per 10K (p=0.11), while overall syphilis reactivity representative of previous as well as more recent infection increased significantly post-IDA (from 2.81 per 10K to 4.00 per 10K, p=0.0001) (Figure A).

Conclusions:

This is the first impact analysis from a large national US blood collector following IDA implementation. IDA implementation resulted in no significant difference in male vs. female deferral rates with the new questionnaire. While IDA implementation did not increase rates of confirmed IDM reactivity for HIV, HBV and active or recently-treated syphilis as compared to a pre-IDA period, rates for more remote/treated syphilis were likely responsible for statistically significantly higher treponemal Ab test reactivity. Syphilis diagnoses are increasing in the US, confounding interpretation of these findings.