| Autor: |
Thorpe SJ; Division of Haematology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK. sthorpe@nibsc.ac.uk, Fox BJ, Dolman CD, Thorpe R |
| Jazyk: |
angličtina |
| Zdroj: |
Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2005 Jun; Vol. 33 (2), pp. 111-6. |
| DOI: |
10.1016/j.biologicals.2005.02.002 |
| Abstrakt: |
The European Pharmacopoeia requires that manufacturers assess intravenous immunoglobulin (IVIG) products for antibodies against blood groups A and B using an indirect anti-globulin test (AGT). However, this method suffers from the disadvantage that the anti-globulin reagent may be neutralised by excess IgG and invalidate the data generated. In view of this, we have used a direct microtitre-based haemagglutination method to screen batches of IVIG products from five manufacturers for anti-A and anti-B, and compared the titres with those reported by the manufacturers. The range of reported titres varied 32-fold across the different products, whereas virtually all the direct method titres fell within a 4-fold range for each specificity. This indicated that the discrepancies in reported titres were due to inconsistencies in manufacturers' testing methodology and/or interpretation of results. Our finding that the anti-globulin reagent used to bring about agglutination of anti-A- or anti-B-sensitised erythrocytes in the AGT was neutralised by excess IgG at least down to a 1 in 8 dilution of IVIG (from 5% (w/v) IgG) casts serious doubts on the suitability of the AGT for testing high immunoglobulin concentration products. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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