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Inter-laboratory validation of the in-vivo flow cytometric micronucleus analysis method (MicroFlow (R)) in China

文献类型：期刊论文

作者Chang, Yan9; Zhou, Changhui9; Huang, Fanghua10; Torous, Dorothea K.11; Luan, Yang1; Shi, Chang2; Wang, Hongling3; Wang, Xin4; Wei, Na5; Xia, Zhenna6
刊名MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS
出版日期2014-09-15
卷号772页码:6-13
ISSN号1383-5718
关键词Micronucleus Genotoxicity Flow cytometry Clastogen Aneugen Validation
DOI10.1016/j.mrgentox.2014.04.027
文献子类Article
英文摘要Although inter-laboratory validation efforts of the in-vivo micronucleus (MN) assay based on flow cytometry (FCM) have taken place in the EU and US, none have been organized in China. Therefore, an inter-laboratory study that included eight laboratories in China and one experienced reference laboratory in the US was coordinated to validate the in-vivo FCM MicroFlow (R) method to determine the frequency of micro-nucleated reticulocytes (MN-RETs) in rat blood. Assay reliability and reproducibility were evaluated with four known genotoxicants, and the results obtained with the FCM method were compared with the outcome of the traditional evaluation of bone-marrow micronuclei by use of microscopy. Each of the four chemicals was tested at three sites (two in China and the one US reference laboratory). After three consecutive daily exposures to a genotoxicant, blood and bone-marrow samples were obtained from rats 24h after the third dose. MN-RET frequencies were measured in 20,000 RET in blood by FCM, and micro-nucleated polychromatic erythrocyte (MN-PCE) frequencies were measured in 2,000 PCEs in bone marrow by microscopy. For both methods, each genotoxicant was shown to induce a statistically significant increase in the frequency of MN after treatment with at least one dose. Where more doses than one caused an increase, responses occurred in a dose-dependent manner. Spearman's correlation coefficient (r(s)) for FCM-based MN-RET vs microscopy-based MN-PCE measurements (eight experiments, 200 paired measurements) was 0.723, indicating a high degree of correspondence between methods and compartments. The r(s) value for replicate FCM MN-RET measurements performed at the eight collaborative laboratories was 0.940 (n = 200), and between the eight FCM laboratories with the reference laboratory was 0.933 (n = 200), suggesting that the automated method is very well transferable between laboratories. The FCM micronucleus analysis method is currently used in many countries worldwide, and these data support its use for evaluating the in-vivo genotoxic potential of test chemicals in China. (C) 2014 Elsevier B.V. All rights reserved.
WOS关键词PERIPHERAL-BLOOD RETICULOCYTES ; MONITORING CHROMOSOMAL DAMAGE ; EFFICIENT METHOD ; RAT ; ERYTHROCYTES ; MICROSCOPY ; CELLS ; ASSAY
资助项目Ministry of Science and Technology[2012ZX09505001-003] ; Genetic Toxicology Professional Committee, Chinese Society of Toxicology (CST)[00000000] ; Drug Toxicology and Safety Evaluation Professional Committee, CST[00000000] ; Mutagenesis Professional Committee, Chinese Environmental Mutagen Society[00000000] ; Drug Safety Evaluation Research Professional Committee, Chinese Pharmaceutical Association[00000000] ; Toxicology Professional Committee, Shanghai Pharmacological Society[00000000] ; National Shanghai Center for New Drug Safety Evaluation and Research[00000000]
WOS研究方向Biotechnology & Applied Microbiology ; Genetics & Heredity ; Toxicology
语种英语
出版者ELSEVIER SCIENCE BV
WOS记录号WOS:000342528100002
源URL[http://119.78.100.183/handle/2S10ELR8/276902]  
专题药物安全性评价中心
通讯作者Wang, Qingli
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, Ctr Drug Safety Evaluat & Res, Shanghai 200031, Peoples R China;
2.Natl Beijing Ctr Drug Safety Evaluat & Res, Beijing Inst Pharmacol & Toxicol, Beijing, Peoples R China;
3.Joinn Labs, Beijing, Peoples R China;
4.Natl Inst Food & Drug Control, Inst Food & Drug Safety Evaluat, Beijing, Peoples R China;
5.Natl Chengdu Ctr Safety Evaluat Drugs, Chengdu, Sichuan, Peoples R China;
6.Second Mil Med Univ, Ctr Evaluat Drug Safety, Shanghai, Peoples R China;
7.WuXi AppTec Suzhou Co Ltd, Suzhou, Jiangsu, Peoples R China;
8.Becton Dickinson Med Devices Shanghai Co Ltd, Shanghai, Peoples R China
9.China State Inst Pharmaceut Ind, Natl Shanghai Ctr New Drug Safety Evaluat & Res, Shanghai, Peoples R China;
10.China Food & Drug Adm, Ctr Drug Evaluat, Beijing, Peoples R China;
推荐引用方式
GB/T 7714		 Chang, Yan,Zhou, Changhui,Huang, Fanghua,et al. Inter-laboratory validation of the in-vivo flow cytometric micronucleus analysis method (MicroFlow (R)) in China[J]. MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS,2014,772:6-13.
APA Chang, Yan.,Zhou, Changhui.,Huang, Fanghua.,Torous, Dorothea K..,Luan, Yang.,...&Ma, Jing.(2014).Inter-laboratory validation of the in-vivo flow cytometric micronucleus analysis method (MicroFlow (R)) in China.MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS,772,6-13.
MLA Chang, Yan,et al."Inter-laboratory validation of the in-vivo flow cytometric micronucleus analysis method (MicroFlow (R)) in China".MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS 772(2014):6-13.

入库方式： OAI收割

来源：上海药物研究所

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