Anderson Steven A, Yang Hong, Gallagher Lou M, O'Callaghan Sharon, Forshee Richard A, Busch Michael P, McKenna Matthew T, Williams Ian, Williams Alan, Kuehnert Matthew J, Stramer Susan, Kleinman Steve, Epstein Jay, Dayton Andrew I
Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852-1448, USA.
Transfusion. 2009 Jun;49(6):1102-14. doi: 10.1111/j.1537-2995.2009.02124.x. Epub 2009 Mar 20.
Implementation of sensitive screening methods for human immunodeficiency virus (HIV) and hepatitis viruses prompts the question of what quantitative risks may result from altered deferral strategies for donation of blood by men who have had sex with men (MSM).
Quantitative probabilistic models were developed to assess changes in the residual risk of transfusion-transmitted HIV and hepatitis B virus (HBV) associated with blood testing and quarantine release errors (QREs) in the initial year of two hypothetical policy scenarios that would allow donations from donors who have abstained from MSM behavior for at least 5 years (MSM5) or at least 1 year (MSM1).
The MSM5 and MSM1 models, respectively, predicted annual increases in units of HIV-infected blood of 0.5% (0.03 mean additional units; 95% confidence interval [CI], 0-1) and 3.0% (0.18 mean additional units; 95% CI, 0-1) over current estimated HIV residual risk using recent, nationwide biologic product deviation reports to estimate QRE rates. These estimates are approximately 10-fold lower than estimates based on New York State QRE data from the previous decade. The models predicted smaller increases in infectious HBV donations.
QREs remain the most significant preventable source of risk. More accurate inputs, including the percentage of MSM in the population, the percentage of MSM who have abstained from MSM activity for 1 or 5 years, the prevalence of HIV and HBV in MSM who have abstained from MSM activity for 1 or 5 years, the rate of self-deferral, and QRE rates, are required before making more precise predictions.
实施针对人类免疫缺陷病毒（HIV）和肝炎病毒的敏感筛查方法引发了一个问题，即男男性行为者（MSM）献血延期策略的改变可能会带来怎样的定量风险。
建立了定量概率模型，以评估在两种假设政策情景的第一年中，与血液检测和检疫放行错误（QREs）相关的输血传播HIV和乙型肝炎病毒（HBV）残余风险的变化。这两种情景允许已戒除男男性行为至少5年（MSM5）或至少1年（MSM1）的献血者献血。
使用近期全国性生物制品偏差报告来估计QRE率，MSM5和MSM1模型分别预测，与当前估计的HIV残余风险相比，HIV感染血液单位的年增加率分别为0.5%（平均增加0.03个单位；95%置信区间[CI]，0 - 1）和3.0%（平均增加0.18个单位；95%CI，0 - 1）。这些估计值比基于前十年纽约州QRE数据的估计值低约10倍。模型预测感染性HBV献血的增加幅度较小。
QREs仍然是最主要的可预防风险来源。在做出更精确的预测之前，需要更准确的输入数据，包括人群中MSM的比例、已戒除男男性行为1年或5年的MSM的比例、已戒除男男性行为1年或5年的MSM中HIV和HBV的流行率、自我延期率以及QRE率。
