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Immunogenicity of recombinant human erythropoietin in Korea: A two-year cross-sectional study.
MedLine Citation:
PMID:  22391230     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Immunogenicity of erythropoietin (EPO) is related with pure red cell aplasia (PRCA). We sought to determine the prevalence of antibody (Ab)-mediated PRCA in Korea and threshold diagnostic criteria by dual parameters: Ab titer and neutralizing activity. This study was a multi-center, cross-sectional study for two years. In the first year study (1 YS), 209 samples suspected to be EPO resistance were collected. In the second year study (2 YS), all the patients who consented to participate (N = 946) were enrolled. In 1 YS, we found three and six serum samples that were positive and borderline for anti-EPO Abs, respectively. The first three patients had neutralizing activity (NT) and were diagnosed as PRCA. In 2 YS, seven patients were anti-EPO positives and six had borderline levels. Among them, one patient with NT was diagnosed as PRCA and one with NT as aplastic anemia. The prevalence of PRCA was 0.106%. The correlation analysis of the 22 patients who had anti-EPO Ab showed that dual crossed cut-off lines (anti-EPO Ab titer ≥ 40 ng/ml, % NT ≥ 25%) were able to clearly isolate red cell aplasia. We suggest novel diagnostic criteria for diagnosis and prediction of Ab-mediated PRCA with data from both Ab titer assays and NT bioassays.
Authors:
Sug-Kyun Shin; Sung Jin Moon; Sung Kyu Ha; Young-Il Jo; Tae-Won Lee; Young Sook Lee; Yang-Wook Kim; Dae Joong Kim; Jin Kuk Kim; Tae-Hyun Yoo; Kyu-Beck Lee; Seung Ok Choi; Ea Wha Kang; Kang Wook Lee; Sung-Jo Kim; Sang Kyum Kim; Tae-Hwe Heo
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-3
Journal Detail:
Title:  Biologicals : journal of the International Association of Biological Standardization     Volume:  -     ISSN:  1095-8320     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9004494     Medline TA:  Biologicals     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
Affiliation:
Ilsan Hospital, National Health Insurance Cooperation, Goyang, Republic of Korea.
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