American Red Cross, Biomedical Services Division, Washington, District of Columbia, USA.
American Red Cross, Biomedical Services Division, Peoria, Illinois, USA.
Transfusion. 2022 Sep;62(9):1727-1730. doi: 10.1111/trf.17021. Epub 2022 Jul 15.
Prior studies have shown that sickle cell trait (SCT) is the most common reason attributed to leukoreduction (LR) filter failure due to physical blockage. However, current Food and Drug Administration (FDA) guidelines do not require blood collectors to take a specific action to mitigate inadequate LR that may occur among donors with SCT. We sought to determine the scope of inadequate LR among whole blood (WB) donations collected from individuals with SCT and processed under standard manufacturing conditions.
Between 8/2021 and 2/2022, a total of 40 red blood cells units (RBCs) manufactured from WB donations collected from donors historically positive for SCT had residual leukocyte testing performed. All 40 of the units had appeared to successfully complete leukofiltration.
Out of the 40 units tested, 22 failed routine residual leukocyte quality control testing (55% failure rate, 95% confidence interval 40%-70%). Nine out of the 22 failures resulted in more than 100 residual leukocytes per microliter of product.
Even when leukofiltration appears to have been completed successfully, WB units collected from donors with SCT have a high (55% in aggregate) rate of inadequate leukoreduction. Correlating this result with previous studies showing that of up to 50% of WB units collected from donors with SCT fail to pass through the leukoreduction filter, we estimate that only 25% of WB donations collected from individuals with SCT will result in a leukoreduced RBC unit that meets all FDA requirements. Blood centers should encourage individuals with SCT to donate platelets or plasma, rather than WB.
先前的研究表明，镰状细胞特征（SCT）是导致白细胞减少（LR）过滤器因物理堵塞而失效的最常见原因。然而，目前的食品和药物管理局（FDA）指南并未要求采血人员采取特定措施来减轻 SCT 供体中可能出现的 LR 不足。我们旨在确定在标准制造条件下从 SCT 阳性个体采集的全血（WB）捐赠中 LR 不足的范围。
在 2021 年 8 月至 2022 年 2 月期间，对从历史上 SCT 阳性的供体采集的共 40 个 RBC 单位的 WB 捐赠进行了残留白细胞检测。所有 40 个单位似乎都成功地完成了白细胞滤除。
在测试的 40 个单位中，有 22 个单位的常规残留白细胞质量控制检测失败（55%的失败率，95%置信区间 40%-70%）。在 22 次失败中，有 9 次导致每微升产品中残留白细胞超过 100 个。
即使白细胞滤除似乎已经成功完成，从 SCT 供体采集的 WB 单位的 LR 不足率也很高（总体为 55%）。将这一结果与先前的研究结果相比较，即多达 50%的从 SCT 供体采集的 WB 单位未能通过 LR 过滤器，我们估计只有 25%的来自 SCT 个体的 WB 捐赠将产生符合所有 FDA 要求的 LR 减少的 RBC 单位。血液中心应鼓励 SCT 个体捐献血小板或血浆，而不是 WB。
