Buccheri Renata, Whitaker Barbee, Pollack Lance M, Bhaskar Jahnavi Reddy, Di Germanio Clara, Guillon Geraldine, Haaland Richard, Stramer Susan L, Reik Rita, Pandey Suchitra, Stone Mars, Anderson Steven A, Marks Peter, Custer Brian
Department of Epidemiology, Vitalant Research Institute, San Francisco, California, USA.
Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA.
Transfusion. 2025 Jul;65(7):1273-1283. doi: 10.1111/trf.18275. Epub 2025 May 5.
In 2023, the United States Food and Drug Administration revised its blood donor eligibility policy for men who have sex with men (MSM) from a 3-month deferral to individual assessment. Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis (PrEP) use remains a reason for deferral, and nondisclosure is a concern.
In a cross-sectional study of sexually active MSM from 8 U.S. cities who were interested in future blood donation, we assessed the performance of an enzyme-linked immunosorbent assay for detecting tenofovir (TFV) in whole blood (WB) and plasma and the correlation with self-reported PrEP use.
Of 1548 individuals, 48% reported oral PrEP use. The WB assay identified 95% of PrEP users, while the plasma assay detected 88%. The WB assay performed well up to 14 days after the last reported dose. Receiver operating characteristics curve analysis showed an area under the curve of 0.96 (95% confidence interval [CI]: 0.95-0.97) using WB and 0.88 (95% CI: 0.86-0.90) using plasma. Specificity was 80% for WB and 66% for plasma. Detection rates for TFV disoproxil fumarate/emtricitabine (FTC) formulations were 99% in WB and 98% in plasma, compared to 93% and 86% for the TFV alafenamide/FTC formulation.
High concordance between self-reported oral PrEP use and TFV detection was observed among PrEP users, suggesting the potential utility of WB as a biomatrix for TFV detection to support screening strategies. Given the expanded eligibility for MSM, who may be PrEP users, to donate blood, further examination of undisclosed PrEP use is important.
2023年，美国食品药品监督管理局将男男性行为者（MSM）的献血资格政策从推迟3个月改为进行个人评估。使用人类免疫缺陷病毒（HIV）暴露前预防（PrEP）仍然是推迟献血的一个原因，且存在隐瞒不报的问题。
在一项对来自美国8个城市、有未来献血意愿的性活跃MSM的横断面研究中，我们评估了一种酶联免疫吸附测定法检测全血（WB）和血浆中替诺福韦（TFV）的性能以及与自我报告的PrEP使用情况的相关性。
在1548名个体中，48%报告使用口服PrEP。全血检测法识别出95%的PrEP使用者，而血浆检测法检测出88%。全血检测法在最后一次报告用药剂量后的14天内表现良好。受试者工作特征曲线分析显示，使用全血时曲线下面积为0.96（95%置信区间[CI]：0.95 - 0.97），使用血浆时为0.88（95% CI：0.86 - 0.90）。全血检测法的特异性为80%；血浆检测法的特异性为66%。富马酸替诺福韦二吡呋酯/恩曲他滨（FTC）制剂在全血中的检测率为99%，在血浆中为98%，而替诺福韦艾拉酚胺/FTC制剂在全血和血浆中的检测率分别为93%和86%。
在PrEP使用者中，自我报告的口服PrEP使用情况与TFV检测之间存在高度一致性，这表明全血作为用于TFV检测的生物基质以支持筛查策略具有潜在效用。鉴于MSM（可能是PrEP使用者）献血资格的扩大，进一步检查未披露的PrEP使用情况很重要。
