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Antibodies to bovine and human coagulation proteins have been reported to develop in some patients receiving perioperative exposure to topical bovine thrombin. To estimate the prevalence of antihuman and antibovine thrombin and factor V antibodies in the general population, this multicenter pilot study in 278 participants was undertaken. Of the participants, 88% had no detectable antibodies by enzyme-linked immunosorbent assay (ELISA). Cumulatively 22 (7.9%) of 278 of the participants were positive for at least 1 of the antibovine antibodies and only 11 (4%) of 278 were positive for human thrombin antibodies. No participants had antihuman factor V/Va antibodies. Antibodies were found in 21% of participants with no history of surgery, transfusion, or pregnancy. In participants without a surgical history, thus a low likelihood of bovine thrombin exposure, 7.9% (9 of 114) had antibovine antibodies and 3.5% (4 of 114) had human antithrombin antibodies, suggesting that antibodies may arise from contact with antigenic sources other than bovine-derived thrombin.

A Multicenter Pilot Study to Estimate the Prevalence of Bovine and Human Coagulation Antibodies in the General US Population