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KMID : 0380420170410040174
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Journal of Prventive Veterinary Medicine
2017 Volume.41 No. 4 p.174 ~ p.179
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Condition establishment study of the direct peptide reactivity assay in Korea
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Park Kyo-Hyun
Song Goon-Cheol
Choo Hwan-Yong
Heo Yong
Kim Bae-Hwan
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Abstract
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The purpose of this study is to set the method condition of the DPRA in Korea throughout reproducibility study. We conducted intra-lab (triplicate) and inter-lab (three labs of CRI, KTR and CU) validation using 20 chemicals (10 chemicals for the proficiency test listed in the OECD test guideline 442C and an additional 10 more chemicals from reference papers). The data from all three labs met the acceptance criteria. Upon intra-lab validation, two positive chemicals out of 20 total chemicals showed false negative, and one negative chemical showed false positive. In inter-lab validation of three labs, the sensitivity data were 83, 83 and 88% each, and the specificity data was 100, 100 and 88% each. So the accuracy of the three labs was equal to 90%. During these studies, we also checked and improved various limitations that arose. Taken together, the results indicated that the DPRA proposed by OECD test guideline 442C is expected to become a well-established method under Korean GLP applied system.
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KEYWORD
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Skin sensitization, DPRA, validation study, condition setting, Korea
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