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Performance standard-based validation study for local lymph node assay: 5-bromo-2-deoxyuridine-flow cytometry method

Title
Performance standard-based validation study for local lymph node assay: 5-bromo-2-deoxyuridine-flow cytometry method
Authors
Ahn, IlyoungKim, Tae-SungJung, Eun-SunYi, Jung-SunJang, Won-HeeJung, Kyoung-MiPark, MiyoungJung, Mi-SookJeon, Eun-YoungYeo, Kyeong-ukJo, Ji-HoonPark, Jung-EunKim, Chang-YulPark, Yeong-ChulSeong, Won-KeunLee, Ai YoungChun, Young JinJeong, Tae CheonJeung, Eui BaeLim, Kyung-MinBae, SeungJinSohn, SoojungHeo, Yong
Ewha Authors
배승진임경민
SCOPUS Author ID
배승진scopus; 임경민scopus
Issue Date
2016
Journal Title
REGULATORY TOXICOLOGY AND PHARMACOLOGY
ISSN
0273-2300JCR Link1096-0295JCR Link
Citation
vol. 80, pp. 183 - 194
Keywords
Performance standardsValidation studyLocal lymph node assayLLNA: BrdU-FCMSkin sensitizationFlow cytometry
Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
Indexed
SCI; SCIE; SCOPUS WOS
Abstract
Local lymph node assay: 5-bromo-2-deoxyuridine-flow cytometry method (LLNA: BrdU-FCM) is a modified non-radioisotopic technique with the additional advantages of accommodating multiple end-points with the introduction of FCM, and refinement and reduction of animal use by using a sophisticated prescreening scheme. Reliability and accuracy of the LLNA: BrdU-FCM was determined according to OECD Test Guideline (TG) No. 429 (Skin Sensitization: Local Lymph Node Assay) performance standards (PS), with the participation of four laboratories. Transferability was demonstrated through successfully producing stimulation index (SI) values for 25% hexyl cinnamic aldehyde (HCA) consistently greater than 3, a predetermined threshold, by all participating laboratories. Within- and between-laboratory reproducibility was shown using HCA and 2,4-dinitrochlorobenzene, in which EC2.7 values (the estimated concentrations eliciting an SI of 2.7, the threshold for LLNA: BrdU-FCM) fell consistently within the acceptance ranges, 0.025-0.1% and 5-20%, respectively. Predictive capacity was tested using the final protocol version 1.3 for the 18 reference chemicals listed in OECD TG 429, of which results showed 84.6% sensitivity, 100% specificity, and 88.9% accuracy compared with the original LLNA. The data presented are considered to meet the performance criteria for the PS, and its predictive capacity was also sufficiently validated. (C) 2016 Elsevier Inc. All rights reserved.
DOI
10.1016/j.yrtph.2016.06.009
Appears in Collections:
약학대학 > 약학과 > Journal papers
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