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KMID : 0380020110260020157
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Korean Journal of Biotechnology and Bioengineering
2011 Volume.26 No. 2 p.157 ~ p.164
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Comparison of 5 Assays for Quantification of Antibody to Hepatitis B Virus Surface Antigen with Immunoglobulin G Preparations
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Shin In-Soo
Lee Yoo-Kyoung
Kim Oh-Jung
Ban Sang-Ja
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Abstract
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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 ± 5.3%) and MEIA (AxSYM: 3.7 ± 1.9%, IMx: 1.6 ± 0.8%) showed precision and accuracy (100.1 ± 12.6%). Therefore, the validated EIA assay was established and it is believed to be comparable to current MEIA
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KEYWORD
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Anti-HBs, Immunoglobulin preparation, Potency, National Lot-Release Test
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