KSBB Journal

The Korean Society for Biotechnology and Bioengineering (한국생물공학회)
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Comparison of 5 Assays for Quantification of Antibody to Hepatitis B Virus Surface Antigen with Immunoglobulin G Preparations

면역글로불린제제 효능평가를 위한 5종 B형간염 표면항원항체검출법의 비교

  • Shin, In-Soo (Blood Products Teams, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Lee, Yoo-Kyoung (Blood Products Teams, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Kim, Oh-Jung (Blood Products Teams, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration) ;
  • Ban, Sang-Ja (Blood Products Teams, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration)
  • 신인수 (식품의약품안전청, 식품의약품안전평가원, 혈액제제검정팀) ;
  • 이유경 (식품의약품안전청, 식품의약품안전평가원, 혈액제제검정팀) ;
  • 김오정 (식품의약품안전청, 식품의약품안전평가원, 혈액제제검정팀) ;
  • 반상자 (식품의약품안전청, 식품의약품안전평가원, 혈액제제검정팀)
  • Received : 2011.02.16
  • Accepted : 2011.03.22
  • Published : 2011.04.30
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Abstract

Five assays for anti-HBs were compared to improve potency test of Human lgG preparations. The three commercial EIA kits were optimized including dose response curve ranges and compared by conducting a co-laboratory study. After selecting the most reproducible EIA kit, methods comparison was performed with 22 samples in 5 different days. As a result, EIA (7.7 ${\pm}$ 5.3%) and MEIA (AxSYM: 3.7 ${\pm}$ 1.9%, IMx: 1.6 ${\pm}$ 0.8%) showed precision and accuracy (100.1 ${\pm}$ 12.6%). Therefore, the validated EIA assay was established and it is believed to be comparable to current MEIA.

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References

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