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Evaluation of anti-hepatitis antibodies in intravenous immunoglobulin products from Iranian plasma
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M. Zadsar   , Z. Sharifi , A. Aghai |
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| Keywords: Key words: Intravenous Immunoglobulin, Hepatitis, Iran, Plasma
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Full-Text [PDF 376 kb]
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| Abstract (HTML) (757 Views)
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Type of Study: Research |
Subject:
Virology
Published: 2023/07/1
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Full-Text: (309 Views) |
References:
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- Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg): European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP); 2021. Available from: https://www. ema. europa. eu/en/ documents/ scientific-guideline/guideline-core-smpc-human-normal-immunoglobulin-intravenous-administration-ivig-rev-6_en.pdf.
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Sci J Iran Blood Transfus Organ 2023;20 (2): 81-89
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Evaluation of anti-hepatitis antibodies in intravenous immunoglobulin products from Iranian plasma
Zadsar M.1, Sharifi Z.1, Aghaie A.1
1Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
Abstract
Background and Objectives
Intravenous immunoglobulin (IVIG) is a biological product containing a mixture of IgGs which is needed to protect special patients against various microbial pathogens. Due to worldwide decrease in the prevalence of viral hepatitis, the protective effect of immunoglobulins in treatment needs to be re-examined. For this reason the presence of, anti-HAV, anti-HBs, Anti HBc, anti-HGV, anti-HDV and anti-HEV antibodies in the IVIG products of Iranian plasma have been investigated.
Materials and Methods
In this randomized descriptive cross-sectional study, the presence or absence of antibodies against hepatitis A, hepatitis E, hepatitis D, hepatitis G, antibodies against hepatitis B surface antigen and hepatitis B core antigen in 38 different lots of IVIG products from the Iranian recovered and source plasma was determined by ELISA method and anti-HAV and anti-HBs antibodies were titrated.
Results
Total anti-HAV in IVIGs was 38304 ± 17735 mIU/mL and this titer was significantly higher in IVIGs from recovered plasma compared with source plasma. Total anti-HBs titer in IVIGs was equal to 2487 ± 965 mIU/mL, and no significant difference was observed between the two types of recovered and source plasma. Anti-HBc, Anti-HEV and Anti-HGV were detected in all products, while no anti-HDV was found.
Conclusions
Despite the worldwide decrease in the prevalence of viral hepatitis and reports of a decrease in anti-HAV and anti-HBs titers in IVIG products, IVIG products prepared from Iranian plasma have acceptable anti-HAV and anti-HBs titers according to the European Pharmacopeia and are suitable for replacement therapy.
Key words: Intravenous Immunoglobulin, Hepatitis, Iran, Plasma
Received: 23 Jan 2023
Accepted: 1 Mar 2023
Correspondence: Aghaie A., PhD of Immunology. Associate Professor of Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine.
P.O.Box: 14665-1157, Tehran, Iran. Tel: (+9821) 82052183; Fax: (+9821) 88601599
E-mail: aghaie.a@gmail.com
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Zadsar M, Sharifi Z, Aghai A. Evaluation of anti-hepatitis antibodies in intravenous immunoglobulin products from Iranian plasma. Sci J Iran Blood Transfus Organ 2023; 20 (2) :81-89 URL: http://bloodjournal.ir/article-1-1480-en.html
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