Allergic Reactions in Healthy Platelet-Pheresis Donors Caused by Sensitization to Ethylene Oxide Gas

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Abstract
We observed immediate-type hypersensitivity reactions in 6 of 600 donors who underwent automated platelet-pheresis procedures. Ethylene oxide gas, which was used to sterilize plastic components in the disposable apheresis kits, represented a possible source of sensitization. In skin-prick testing, 4 of the 6 donors who had had a hypersensitivity reaction and none of 40 controls who had not had such a reaction had positive tests when an ethylene oxide–human serum albumin reagent was used (P<0.001). Radioallergosorbent testing revealed that serum from 4 of the 6 donors who had reactions, but from only 1 of 145 controls, contained IgE antibodies to ethylene oxide–albumin (P<0.001). All six of the donors who had reactions had specific ethylene oxide–induced basophil histamine release (mean release [±SE], 34.2±5.6 percent), whereas none of four controls had specific histamine release in response to ethylene oxide (mean release, 5.7±1.2 percent; P<0.005). Repeat platelet-pheresis in five of the donors who reacted was accompanied by a recurrence of mild allergic symptoms.