Biomolecules & Therapeutics

The Korean Society of Applied Pharmacology (한국응용약물학회)
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Comparative Analysis of Screening Results from Various ELISA Formats Used for Detection of Anti-Erythropoietin Antibodies in Korean Patients

  • Ha, Sung-Kyu (Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, College of Medicine) ;
  • Yang, Seung-Ju (Department of Biomedical Laboratory Science, Konyang University) ;
  • Shin, Sug-Kyun (Department of Internal Medicine, Ilsan Hospital, National Health Insurance Cooperation) ;
  • Jo, Young-Il (Department of Internal Medicine, BK21, Konkuk University School of Medicine) ;
  • Baek, Kyung-Min (Advanced Therapy Products Division, Biopharmaceuticals and Herbal Medicine Bureau, Korea Food and Drug Administration) ;
  • Hong, Seung-Hwa (Center for Lot Release, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Pack, Seung-Pil (Department of Biotechnology and Bioinformatics, Korea University) ;
  • Kim, Sung-Jo (Department of Biotechnology, Hoseo University) ;
  • Heo, Tae-Hwe (Department of Biomedical Laboratory Science, Konyang University)
  • Received : 2010.02.22
  • Accepted : 2010.03.15
  • Published : 2010.04.30
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Abstract

Clinical cases of pure red cell aplasia (PRCA) have been reported during the recombinant human erythropoietin (EPO) therapy for the anemia patients. PRCA is a rare hematological disorder leading to a severe anemia due to an almost complete stop of red blood cell production. Antibody (Ab)-associated PRCA is caused by the EPO-neutralizing Abs that eliminate the biological activity of EPO. In order to detect anti-EPO Abs in human sera, we performed conventional ELISA, directly coated bridging ELISA, and streptavidin coated bridging ELISA, and compared their sensitivity and specificity. Some false positive results were obtained in the conventional ELISA. One positive sample was detected successfully by streptavidin coated bridging ELISA, which was not appeared in the directly coated bridging ELISA. In conclusion, streptavidin coated bridging ELISA was substantially sensitive and specific format and one out of sixty-eight serum samples was proved to be anti-EPO positive.

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References

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