Etiology of Allergic Reactions in Platelet and Granulocytapheresis Donors

1984年2月，DTM由手工 自动血小板采集技术。在未来10 年，26名供体在Fenwal接受单采手术 CS-3000器械发生急性超敏反应。 血小板单采过程中发生16例反应， 发生在粒细胞置换术过程中。使用 皮肤试验、放射性过敏吸附试验（RAST）和 嗜碱性粒细胞组胺释放试验，我们发现特异性IgE介导的 环氧乙烷（EO）致敏，一种用于对 塑料一次性单采试剂盒，10/16例血小板单采供体 10个粒细胞单采供体中有8个出现反应，但 在140个无反应的对照组中没有。有EO记录的捐助者 致敏性从随后的单采中永久推迟 这些研究的结果报告给了 CS-3000单采设备的制造商和FDA。类似 另一组在血浆置换供体中报告了反应。 由于这些报告，CS-3000的制造商 一次性单采试剂盒改变了他们的灭菌技术， 主要是EO暴露于主要是伽马辐照。 自这一变化以来，只有两个记录在案的案件， 1995年8月DTM供体中的EO超敏反应， 1998年3月然而，1997年8月，一名献血者在另一份血液中 中心在治疗期间发生了急性致死性过敏反应。 血小板去除术，并在死后测试中发现， IgE抗EO滴度。捐献者也有严重的哮喘病史。 这是第一次报告的致命过敏反应，EO在一个 血液成分分离捐献者，并重新提出了前瞻性的问题， 筛选所有单采供体的EO致敏性。我们有 据估计，在所有重复单采献血者中， 可能会对EO敏感，尽管只有一小部分 过敏的人会有临床上明显的过敏反应。到 记录捐助者目前对环氧乙烷的敏感率， 将这一比率与职业暴露的个人进行比较， 对于EO，我们与CBER/FDA建立了合作关系。 筛选约500名健康重复单采献血者 使用已建立的RAST测试和实验性EIA测试 将进行IgE抗EO检测。一组血清样本 储存在疾病预防控制中心和来自个人过敏 还将测试假定由EO引起的反应， 来自NHANES研究的大样本。

In February, 1984, the DTM converted from manual to automated platelet collection techniques. During the next 10 years, 26 donors undergoing apheresis procedures on the Fenwal CS-3000 device experienced acute hypersensitivity reactions. Sixteen reactions occurred during plateletpheresis and 10 reactions occurred during granulocytapheresis procedures. Using a combination of skin tests, radioallergosorbent tests (RAST), and basophil histamine release assays, we found specific IgE-mediated sensitization to ethylene oxide (EO), a gas used to sterilize the plastic disposable apheresis kits, in 10 of 16 plateletpheresis donors and 8 of 10 granulocytapheresis donors experiencing reactions, but in none of 140 nonreacting controls. Donors with documented EO sensitization were permanently deferred from subsequent apheresis donations.The results of these studies were reported to the manufacturer of the CS-3000 apheresis device and to FDA. Similar reactions were reported by another group in plasmapheresis donors. As a result of these reports, the manufacturer of the CS-3000 disposable apheresis kits changed their sterilization techniques from predominantly EO exposure to predominantly gamma irradiation. Since this change, there have been only two documented cases of EO hypersensitivity reactions in DTM donors, in August 1995 and March 1998. However, in August 1997, a donor in another blood center had an acute fatal anaphylactic reaction during plateletpheresis, and was found on postmortem testing to have high titer IgE anti-EO. The donor also had a strong history of asthma. This was the first report of a lethal allergic reaction to EO in an apheresis donor, and has reopened the question of prospective screening of all apheresis donors for EO sensitization. We have estimated that as many as 1.0 percent of all repeat apheresis donors may become sensitized to EO, although only a fraction of those who are sensitized will have clinically evident allergic reactions. To document the current EO sensitization rate among donors and to compare this rate with individuals who have occupational exposure to EO, we have established a collaborative effort with CBER/FDA. Screening of approximately 500 healthy repeat apheresis donors using both an established RAST test and an experimental EIA test for IgE anti-EO will be performed. A cohort of serum samples stored at the CDC and derived from individuals with allergic reactions presumed to be due to EO will also be tested, as will a large sample of samples derived from the NHANES study.