HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS
The safety issues of human intravenous immunoglobulin preparations are particularly important in modern pharmacotherapy for immunodeficiencies, hematologic and neurologic diseases, like as at transplant centers. Upon massive infusions of these media some complications are detected that are associate...
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oai:doaj.org-article:9176efd1e95141ebbebf1d4eb9d38e832021-11-18T08:03:46ZHAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS1563-06252313-741X10.15789/1563-0625-2017-5-513-520https://doaj.org/article/9176efd1e95141ebbebf1d4eb9d38e832017-10-01T00:00:00Zhttps://www.mimmun.ru/mimmun/article/view/1350https://doaj.org/toc/1563-0625https://doaj.org/toc/2313-741XThe safety issues of human intravenous immunoglobulin preparations are particularly important in modern pharmacotherapy for immunodeficiencies, hematologic and neurologic diseases, like as at transplant centers. Upon massive infusions of these media some complications are detected that are associated with spontaneous activation of complement system accompanied by production of anaphylatoxins, as well as activation of kallikrein/kinin, plasmin, and blood coagulation systems, changed blood rheology, initiation of intravascular hemolysis. For distinct groups of patients, these complications may be due to presence of some anti-erythrocyte antibodies (e.g., anti-A and anti-B haemagglutinins, anti-D antibodies) in the intravenous human immunoglobulin preparations. In the present review article, we show development of current quality standards for human intravenous immunoglobulins based on determination of antibody contents. Antibodies to erythrocytes represent a special safety index aiming to minimize risk of possible adverse effects connected with transfusions of human blood preparations. Different haemagglutination tests were compared to assess contents of anti-A, anti-B haemagglutinins and anti-D antibodies for specific safety of human intravenous immunoglobulins. Analysis of haemagglutination techniques for evaluation of human intravenous immunoglobulin preparations revealed their relative advantages and disadvantages. Various modifications of the methods are discussed, thus allowing to optimize process of quality control for these preparations based on detection of haemagglutinins and anti-D antibodies. We demonstrate a necessity to adjust regulations and to improve evaluation techniques for haemagglutinin determination in human immunoglobulin preparations at amounts of 100 mg/ml of protein. Special features of Russian national quality standards for human immunoglobulin preparations are considered with respect to assessment of haemagglutinins and anti-D contents. One may conclude that haemagglutination methods present the most informative and economically substantiated approach when assessing specific safety of human intravenous immunoglobulins by measuring contents of anti-A, anti-B haemagglutinins, and anti-D antibodies.O. G. KornilovaE. V. ParamonovaA. V. NechaevE. Yu. KudashevaI. V. BorisevichN. I. KishkurnoSPb RAACIarticlehuman immunoglobulinspecific safetyanti-a and anti-b haemagglutininsanti-d antibodieshaemagglutination assaysImmunologic diseases. AllergyRC581-607RUMedicinskaâ Immunologiâ, Vol 19, Iss 5, Pp 513-520 (2017) |
institution |
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DOAJ |
language |
RU |
topic |
human immunoglobulin specific safety anti-a and anti-b haemagglutinins anti-d antibodies haemagglutination assays Immunologic diseases. Allergy RC581-607 |
spellingShingle |
human immunoglobulin specific safety anti-a and anti-b haemagglutinins anti-d antibodies haemagglutination assays Immunologic diseases. Allergy RC581-607 O. G. Kornilova E. V. Paramonova A. V. Nechaev E. Yu. Kudasheva I. V. Borisevich N. I. Kishkurno HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS |
description |
The safety issues of human intravenous immunoglobulin preparations are particularly important in modern pharmacotherapy for immunodeficiencies, hematologic and neurologic diseases, like as at transplant centers. Upon massive infusions of these media some complications are detected that are associated with spontaneous activation of complement system accompanied by production of anaphylatoxins, as well as activation of kallikrein/kinin, plasmin, and blood coagulation systems, changed blood rheology, initiation of intravascular hemolysis. For distinct groups of patients, these complications may be due to presence of some anti-erythrocyte antibodies (e.g., anti-A and anti-B haemagglutinins, anti-D antibodies) in the intravenous human immunoglobulin preparations. In the present review article, we show development of current quality standards for human intravenous immunoglobulins based on determination of antibody contents. Antibodies to erythrocytes represent a special safety index aiming to minimize risk of possible adverse effects connected with transfusions of human blood preparations. Different haemagglutination tests were compared to assess contents of anti-A, anti-B haemagglutinins and anti-D antibodies for specific safety of human intravenous immunoglobulins. Analysis of haemagglutination techniques for evaluation of human intravenous immunoglobulin preparations revealed their relative advantages and disadvantages. Various modifications of the methods are discussed, thus allowing to optimize process of quality control for these preparations based on detection of haemagglutinins and anti-D antibodies. We demonstrate a necessity to adjust regulations and to improve evaluation techniques for haemagglutinin determination in human immunoglobulin preparations at amounts of 100 mg/ml of protein. Special features of Russian national quality standards for human immunoglobulin preparations are considered with respect to assessment of haemagglutinins and anti-D contents. One may conclude that haemagglutination methods present the most informative and economically substantiated approach when assessing specific safety of human intravenous immunoglobulins by measuring contents of anti-A, anti-B haemagglutinins, and anti-D antibodies. |
format |
article |
author |
O. G. Kornilova E. V. Paramonova A. V. Nechaev E. Yu. Kudasheva I. V. Borisevich N. I. Kishkurno |
author_facet |
O. G. Kornilova E. V. Paramonova A. V. Nechaev E. Yu. Kudasheva I. V. Borisevich N. I. Kishkurno |
author_sort |
O. G. Kornilova |
title |
HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS |
title_short |
HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS |
title_full |
HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS |
title_fullStr |
HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS |
title_full_unstemmed |
HAEMAGGLUTINATION TECHNIQUES TO EVALUATE SPECIFIC SAFETY OF HUMAN INTRAVENOUS IMMUNOGLOBULINS |
title_sort |
haemagglutination techniques to evaluate specific safety of human intravenous immunoglobulins |
publisher |
SPb RAACI |
publishDate |
2017 |
url |
https://doaj.org/article/9176efd1e95141ebbebf1d4eb9d38e83 |
work_keys_str_mv |
AT ogkornilova haemagglutinationtechniquestoevaluatespecificsafetyofhumanintravenousimmunoglobulins AT evparamonova haemagglutinationtechniquestoevaluatespecificsafetyofhumanintravenousimmunoglobulins AT avnechaev haemagglutinationtechniquestoevaluatespecificsafetyofhumanintravenousimmunoglobulins AT eyukudasheva haemagglutinationtechniquestoevaluatespecificsafetyofhumanintravenousimmunoglobulins AT ivborisevich haemagglutinationtechniquestoevaluatespecificsafetyofhumanintravenousimmunoglobulins AT nikishkurno haemagglutinationtechniquestoevaluatespecificsafetyofhumanintravenousimmunoglobulins |
_version_ |
1718422366023843840 |