Tracking TRALI Risk in Transgender Donors; Assessing 1-Year Deferral Change for MSM Donors

Dr. Brian Custer speaks during the Donor Deferrals, Reactions and Recruitment oral abstracts session on Monday.

One of the more vexing questions facing blood collection facilities is how to assess anti-HLA antibodies in transgender donors to minimize TRALI risk. Researchers at the American Red Cross (ARC) presented data on the risk of failing to ask transgender (TG) males (birth gender female) about pregnancy. TG males may have had prior pregnancies or conceived after transition from female to male. The researchers identified individuals  in their donation database (or were identified by collections staff) who had changed gender. Donors were contacted to resolve discrepancies. TG male donors who answered yes to the pregnancy question were identified and any HLA test results were reviewed.

From 2013 to 2015, 181 individuals who had changed gender were identified. Of these, 121 donors had changed their gender from female to male. Seven TG male donors (6%) answered Yes to the pregnancy question. One donor tested positive for HLA antibodies; two did not. The remaining four had not been tested, and an HLA test was requested to be performed at the next donation, said Kathleen Grima, MD, who presented the research. Grima is the executive medical director at ARC and medical director of The Brooklyn Hospital Center Blood Bank.

The researchers also identified donors who requested their gender be changed from female to male after May 2016, when FDA’s Final Rule went into effect. In the rule, FDA  recommended to blood establishments that “in the context of the donor history questionnaire, male or female gender should be self-identified and self-reported for the purpose of blood donation.” HLA testing was requested for the next donation, Grima reported. A total of 326 such donors were identified. Five (1.5%) answered Yes to the pregnancy question, 56 answered No and 265 did not answer. Testing for HLA antibodies was performed for 101 TG male donors with 13 positive results. Two of these donors had answered Yes to the pregnancy question, four had answered No, and seven had not answered.

Including both time periods, of 447 identified TG male donors, 3% answered Yes to the pregnancy question. One percent of TG male donors tested positive for HLA antibodies.

When a donor requests a gender change from female to male, an HLA test is requested for the next donation, said Grima. However, because first-time donors are qualified based on their stated gender, unless a transgender donor volunteers information about prior pregnancy, this information can easily be missed. Other possible identification strategies include asking all donors about pregnancy; continuing to ask donors about their birth gender and require answers to both male and female questions; simply opting not to accept donations from transgender individuals; or treating all transgender donors as female donors.

Early Effects of Policy Change to 1-Year Deferral for MSM

During the same session, 2017 Hemphill-Jordan Leadership Award winner Brian Custer, MPH, PhD, director of epidemiology and policy science at Blood Systems Research Institute, shared results from an initial assessment of the effects resulting from FDA’s policy change from an indefinite donor deferral to a 1-year deferral for men who have sex with men (MSM). While the number of MSM donors who met the 1-year deferral requirement was too small to draw conclusions, early data suggest higher rates of prevalent infection in some first-time MSM donors. Additional analyses are needed though, said Custer.

At BSI, where the 1-year deferral has been in place for more than a year, MSM deferral rates have declined. A small number of donors qualified to be reinstated; reinstatement has yet to taper off. Continuous monitoring of MSM deferral rates and infectious disease tracking are key to assessing the effectiveness of the new MSM policy.

— Kerri Wachter

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