| 摘要 |
Discloses a method for identifying atypical reactive antibodies in a blood products manufacturing process, the method comprising: (a) testing a sample of blood or plasma and a control for reactivity to rabbit white blood cells using any one or more of cellular agglutination, fluorescence microscopy, immunoprecipitation, immunodiffusion, immunofluorescence, ELISA, flow cytometry, FACS, or Western blotting; (b) comparing the sample and control testing results; (c) determining whether the sample contains atypical reactive antibodies; and; (d) identifying a blood or plasma unit that was the source of the sample if the sample contains atypical reactive antibodies, and wherein the atypical reactive antibodies cross-react with rabbit white blood cell antigens and cause a pyrogenic response during rabbit pyrogen test. Also discloses a related method for evaluating potential false positive pyrogen test results in a blood products manufacturing process. |
