Batches of intravenous immunoglobulin associated with adverse reactions in recipients contain atypically high anti-Rh D activity.
| Autor: | Thorpe SJ; Division of Haematology, National Institute for Biological Standards and Control, Potters Bar, Herts., UK. sthorpe@nibsc.ac.uk, Fox BJ, Dolman CD, Lawrence J, Thorpe R |
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| Jazyk: | angličtina |
| Zdroj: | Vox sanguinis [Vox Sang] 2003 Aug; Vol. 85 (2), pp. 80-4. |
| DOI: | 10.1046/j.1423-0410.2003.00336.x |
| Abstrakt: | Background and Objectives: The presence of anti-Rh D in intravenous immunoglobulin (IVIG) products has been claimed to be associated with adverse reactions in recipients. There is currently no regulatory specification to control the level of anti-D in IVIG products and it is unclear what this should be. Two reports of haemolysis occurring in recipients of IVIG manufactured from US plasma provided a rare opportunity to investigate whether high anti-D levels could have induced the haemolysis. Materials and Methods: We developed a direct microtitre plate haemagglutination method suitable for screening IVIG products and starting plasma pools for haemagglutinating activity. Results: Of 101 batches of IVIG tested, six were found to contain specific anti-D. Four of these batches had anti-D titres ranging from 64 to 256 (including the two batches each associated with a report of haemolysis) and could be linked, in each case, to a starting plasma pool also positive for anti-D. Conclusions: Our results show that IVIG products can contain appreciable anti-D levels. To avoid potential problems in recipients, we propose an anti-D titre of 8 as the maximum permissible limit of anti-D in IVIG products for batch acceptance and release. The availability of a reference preparation is essential for control of this proposed requirement. |
| Databáze: | MEDLINE |
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