Revision of Standards for Microbiological and Parasitological Grades in Laboratory Animals and Its Comparison to Foreign Standards

doi:10.12300/j.issn.1674-5817.2023.088

Abstract

Abstract:

The national standard, GB 14922-2022 on "Laboratory Animal Microbiological and Parasitical standards and monitoring " was implemented on July 1st, 2023. This article is compiled according to the speech of the 16^th East China Laboratory Annual meeting, explores and critically analyzes the developments made to the revised standard and examines how this framework compares with quality control programs of other established international institutions. The key aspects of establishing quality monitoring programs for animal-associated microorganisms in laboratory animal facilities are briefly discussed.

Key words: National standards, Microorganisms, Laboratory animals, Quality monitoring program

CLC Number:

Q95-33

Lianxiang GUO. Revision of Standards for Microbiological and Parasitological Grades in Laboratory Animals and Its Comparison to Foreign Standards[J]. Laboratory Animal and Comparative Medicine, 2023, 43(4): 339-346.

Figures/Tables 2

References 31

1	FELASA WORKING GROUP ON REVISION OF GUIDELINES FOR HEALTH MONITORING OF RODENTS AND RABBITS, MÄHLER CONVENOR M, BERARD M, et al. FELASA recommendations for the health monitoring of mouse, rat, hamster, guinea pig and rabbit colonies in breeding and experimental units[J]. Lab Anim, 2014, 48(3):178-192. DOI: 10.1177/0023677213516312 .
2	A guide to modern strategies for infection surveillance of rodent populations [DB/OL].(2022)[2023].https://www.criver.com/resources/info-pi-rm-guidebook-strategies-infection-surveillance.
3	Lists the organisms that are excluded from all Jackson Laboratory animal rooms[DB/OL].(2022)[2023].https://www.jax.org/jax-mice-and-services/customer-support/customer-service/animal-health/list-of-agents-monitored.
4	罗银珠, 闵凡贵, 王静, 等. 病原微生物防控在实验动物设施管理与生物安全控制中的作用探讨[J]. 实验动物与比较医学, 2021, 41(5):443-449. DOI:10.12300/j.issn.1674-5817.2020.219 .
	LUO Y Z, MIN F G, WANG J, et al. Prevention and control of pathogenic microorganisms for the management and biosafety control in laboratory animal facilities[J]. Lab Anim Comp Med, 2021, 41(5):443-449.DOI:10.12300/j.issn.1674-5817.2020.219 .
5	中华人民共和国国家质量监督检验检疫总局. 实验动物寄生虫学等级及监测: [S]. 北京: 中国标准出版社, 2004.
	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. Laboratory animal—Parasitology level and monitoring: [S]. Beijing: China Standards Press, 2004.
6	中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. 实验动物微生物学等级及监测: [S]. 北京: 中国标准出版社, 2011.
	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, administration Standardization. Laboratory animal—Microbiological standards and monitoring: [S]. Beijing: China Standards Press, 2011.
7	国家市场监督管理总局, 国家标准化管理委员会. 实验动物微生物、寄生虫学等级及监测: [S]. 北京: 中国标准出版社, 2022.
	State Administration for Market Regulation, National Standardization Administration. Laboratory animal—Microbiological and parasitical standards and monitoring: [S]. Beijing: China Standards Press, 2022.
8	陶凌云, 周洁, 胡建华, 等. 国内外大鼠和小鼠微生物、寄生虫检测标准的比较[J]. 实验动物与比较医学, 2020,40(2):166-172. DOI:10.3969/j.issn.1674-5817.2020.02.014 .
	TAO L Y, ZHOU J, HU J H, et al. Comparison of microbiological and parasitological monitoring of rats and mice[J]. Lab Anim Comp Med, 2020,40(2):166-172. DOI:10.969/j.issn.1674-5817.2020.02.014 .
9	潘金春, 赵维波, 陈梅玲, 等. 2013年~2015年广东地区实验小鼠和大鼠微生物学及寄生虫学调查[J]. 中国比较医学杂志, 2017, 27(2):64-69, 85. DOI: 10.3969.j.issn.1671-7856.2017.02.012 .
	PAN J C, ZHAO W B, CHEN M L, et al. Microbiological and parasitological investigation in laboratory mice and rats in Guangdong Province from 2013 to 2015[J]. Chin J Comp Med, 2017, 27(2):64-69, 85. DOI: 10.3969.j.issn.1671-7856.2017.02.012 .
10	陈南菊, 陈群. 大学生鼻腔金黄色葡萄球菌带菌状况及药敏检测[J]. 中国校医, 2000, 14(3):167-168. DOI: CNKI:SUN:XIYI.0.2000-03-004 .
	CHEN N J, CHEN Q. Nose Staphylococcus aureus carrier status and drug sensitivity testing among college students[J]. Chin J Sch Dr, 2000, 14(3):167-168. DOI: CNKI:SUN:XIYI.0. 2000-03-004 .
11	马笑雪, 罗恩杰. 社区分离金黄色葡萄球菌在健康人群中的分布及其分子生物学特点[J]. 中华流行病学杂志, 2011, 32(8): 804-807. DOI: 10.3760/cma.j.issn.0254-6450.2011.08.016 .
	MA X X, LUO E J. Distribution of Staphylococcus aureus strains colonized in healthy community population and molecular epidemiological characteristics for MRSA strains[J]. Chin J Epidemiol, 2011, 32(8): 804-807. DOI: 10.3760/cma.j.issn.0254-6450.2011.08.016 .
12	陈百计, 姚泽宇, 王彤, 等. 广州社区人群金黄色葡萄球菌鼻腔携带调查和分子流行特征[J]. 热带医学杂志, 2017, 17(12):1583-1588. DOI: 10.3969/j.issn.1672-3619.2017.12.004 .
	CHEN B J, YAO Z Y, WANG T, et al. Molecular and epidemiological characteristics of nasal carriage of Staphylococcus aureus among the general population in Guangzhou[J]. J Trop Med, 2017, 17(12):1583-1588. DOI: 10.3969/j.issn.1672-3619.2017.12.004 .
13	PERCY D H, BARTHOLD S W, GRIFFEY S M. Pathology of laboratory rodents and rabbits[M]. 4th ed. Ames, Iowa: John Wiley & Sons, Inc., 2016.
14	GOZALO A S, HOFFMANN V J, BRINSTER L R, et al. Spontaneous Staphylococcus xylosus infection in mice deficient in NADPH oxidase and comparison with other laboratory mouse strains[J]. J Am Assoc Lab Anim Sci, 2010, 49(4):480-486. DOI: 10.1111/j.1748-5827.2010.00953.x .
15	KENGKOOM K, AMPAWONG S. Staphylococcus sciuri associated to subcutaneous abscess and dermatitis in ICR mouse[J]. Arq Bras Med Vet Zootec, 2017, 69(1):117-122. DOI: 10.1590/1678-4162-8563 .
16	LABELLE P, HAHN N E, FRASER J K, et al. Mousepox detected in a research facility: case report and failure of mouse antibody production testing to identify Ectromelia virus in contaminated mouse serum[J]. Comp Med, 2009, 59(2):180-186. DOI: 10.1016/j.cbpc.2008.10.106 .
17	刘芳妮, 吕军苹, 柯跃华, 等. 北京地区实验小鼠诺如病毒流行情况[J]. 实验动物与比较医学, 2023, 43(2):205-211. DOI: 10.12300/j.issn.1674-5817.2022.126 .
	LIU F N, LU J P, KE Y H, et al. Prevalence of mouse Norovirus in experimental mice in Beijing[J]. Lab Anim Comp Med, 2023,43(2): 205-211. DOI: 10.12300/j.issn.1674-5817.2022.126 .
18	PRITCHETT-CORNING K R, COSENTINO J, CLIFFORD C B. Contemporary prevalence of infectious agents in laboratory mice and rats[J]. Lab Anim, 2009, 43(2):165-173. DOI: 10.1258/la.2008.008009 .
19	SEAMONS A, P.M TREUTING, MEEKER S, et al. Obstructive lymphangitis precedes colitis in murine Norovirus-infected Stat1-deficient mice[J]. Am J Pathol, 2018, 188(7):1536-1554. DOI: 10.1016/j.ajpath.2018.03.019 .
20	MANUEL C A, PEARSON E C, PUGAZHENTHI U, et al. A clinical scoring systems for the evaluation of Corynebacterium bovis-associated disease in NSG mice[J]. Comp Med, 2022, 72(6):386-393. DOI: 10.30802/aalas-cm-22-000098 .
21	CASSELL G H, DAVIS J K, LINDSEY J R. Control of Mycoplasma pulmonis infection in rats and mice: detection and elimination vs. vaccination[J]. Isr J Med Sci, 1981, 17(7):674-677. DOI: 10.1080/09668136.2014.912853 .
22	COLE B C, GOLIGHTLY-ROWLAND L, WARD J R. Arthritis of mice induced by Mycoplasma arthritidis. Humoral antibody and lymphocyte responses of CBA mice[J]. Ann Rheum Dis, 1976, 35(1):14-22. DOI: 10.1136/ard.35.1.14 .
23	中华人民共和国国家质量监督检验检疫总局. 实验动物微生物学检测方法: [S]. 北京: 中国标准出版社, 2001.
	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. Laboratory animal—Microbiological examination methods: [S]. Beijing: China Standards Press, 2001.
24	ADHIKARY S, NICKLAS W, BISGAARD M, et al. Rodentibacter Gen. nov. including Rodentibacter pneumotropicus comb. nov., Rodentibacter heylii sp. nov., Rodentibacter myodis sp. nov., Rodentibacter ratti sp. nov., Rodentibacter heidelbergensis sp. nov., Rodentibacter trehalosifermentans sp. nov., Rodentibacter rarus sp. nov., Rodentibacter mrazii and two genomospecies[J]. Int J Syst Evol Microbiol, 2017, 67(6):1793-1806. DOI: 10.1099/ijsem.0.001866 .
25	ROEDIGER, LEE Q B., TIKOO S, et al. An atypical parvovirus drives chronic tubulointerstitial nephropathy and kidney fibrosis[J]. Cell, 2018, 175(2):530-543.e24. DOI: 10.1016/j.cell.2018.08.013 .
26	WILLIAMS S H, CHE X Y, GARCIA J A, et al. Viral diversity of house mice in New York city[J]. mBio, 2018, 9(2):e01354-17. DOI: 10.1128/mbio.01354-17 .
27	CRIM M, BESCH-WILLIFORD, HART M L, et al. Mouse kidney parvovirus: A newly characterized parvoviral pathogen of research mice[C]. Prague: FELASA Congress, IBA-US 84-2 MKPV Poster, 2019.
28	COLLYMORE C, GIULIANO F, BANKS E K. Head tilt in immunodeficient mice due to contamination of drinking water by Burkholderia gladioli [J]. J Am Assoc Lab Anim Sci, 2019, 58(2):246-250. DOI: 10.30802/AALAS-JAALAS-18-000106 .
29	王静, 袁文, 闵凡贵, 等. 实验动物病原PCR检测方法系列团体标准的编制[J]. 中国比较医学杂志, 2019, 29(3): 60-66. DOI: 10.3969/j.issn.1671-7856.2019.03.010 .
	WANG J, YUAN W, MIN F G, et al. Establishment of a series of social organization standards on a PCR method for pathogen detection in laboratory animals[J]. Chin J Comp Med, 2019, 29(3): 60-66. DOI: 10.3969/j.issn.1671-7856.2019.03.010 .
30	FOLEY P L, LIPUMA J J, FELDMAN S H. Outbreak of otitis media caused by Burkholderia gladioli infection in immunocompromised mice[J]. Comp Med, 2004, 54(1):93-99. DOI: 10.1053/S1096-2867(03)00084-7 .
31	陈国元, 康康, 李晓娴, 等. 实验材料检测在SPF级实验小鼠质量控制中的应用[J]. 实验动物与比较医学, 2021, 41(1): 61-65. DOI: 10.12300/j.issn.1674-5817.2020.092 .
	CHEN G Y, KANG K, LI X X, et al. Application of experimental material inspection in quality control of SPF mice[J]. Lab Anim Comp Med, 2021, 41(1): 61-65. DOI:10.12300/j.issn.1674-5817.2020.092 .

变化类别 Change category	监测项目（微生物和寄生虫） Monitoring items (microorganisms and parasites)	动物种属 Animal species or genera
删除 Cancel	兔脑原虫Encephalitozoon cuniculi	小鼠、大鼠、豚鼠、仓鼠、兔
	小肠结肠炎耶尔森菌Yersinia enterocolitica
	皮肤病原真菌Pathogenic dermal fungi
	念珠状链杆菌Streptobacillus moniliformis
	假结核耶尔森菌Yersinia pseudotuberculosis	小鼠、大鼠
变更为“必要时检测” Changed to 'Test if necessary'	金黄色葡萄球菌Staphylococcus aureus	小鼠、大鼠、豚鼠、仓鼠、兔
	鼠痘病毒Ectromelia virus	小鼠
	大鼠冠状病毒/涎泪腺炎病毒Rat coronavirus/sialodacryoadenitis virus	大鼠
	猴痘病毒 Monkeypox virus	猴
增加 Addition	牛棒状杆菌Corynebacterium bovis 小鼠诺如病毒Mouse norovirus	免疫缺陷小鼠
名称变更 Name change	猴痘病毒的英文名称从Simian pox virus变为Monkeypox virus	猴
	卡氏肺孢子虫Pneumocystis carinii变更为肺孢子菌属Pneumocystis spp.	小鼠、大鼠、豚鼠、仓鼠、兔
	大肠埃希菌O115 a,C,K（B）变更为啮齿柠檬酸杆菌Citrobacter rodentium	小鼠、大鼠

变化类别 Change category	监测项目（微生物和寄生虫） Monitoring items (microorganisms and parasites)	动物种属 Animal species or genera
删除 Cancel	兔脑原虫Encephalitozoon cuniculi	小鼠、大鼠、豚鼠、仓鼠、兔
	小肠结肠炎耶尔森菌Yersinia enterocolitica
	皮肤病原真菌Pathogenic dermal fungi
	念珠状链杆菌Streptobacillus moniliformis
	假结核耶尔森菌Yersinia pseudotuberculosis	小鼠、大鼠
变更为“必要时检测” Changed to 'Test if necessary'	金黄色葡萄球菌Staphylococcus aureus	小鼠、大鼠、豚鼠、仓鼠、兔
	鼠痘病毒Ectromelia virus	小鼠
	大鼠冠状病毒/涎泪腺炎病毒Rat coronavirus/sialodacryoadenitis virus	大鼠
	猴痘病毒 Monkeypox virus	猴
增加 Addition	牛棒状杆菌Corynebacterium bovis 小鼠诺如病毒Mouse norovirus	免疫缺陷小鼠
名称变更 Name change	猴痘病毒的英文名称从Simian pox virus变为Monkeypox virus	猴
	卡氏肺孢子虫Pneumocystis carinii变更为肺孢子菌属Pneumocystis spp.	小鼠、大鼠、豚鼠、仓鼠、兔
	大肠埃希菌O115 a,C,K（B）变更为啮齿柠檬酸杆菌Citrobacter rodentium	小鼠、大鼠

病毒 Virus	国家标准^a National standards		FELASA^b	JAX^c	CRL^d
病毒 Virus	2022	2011	FELASA^b	JAX^c	CRL^d
鼠痘病毒 Ect.	○	●	○	●	○
小鼠肝炎病毒 MHV	●	●	●	●	●
仙台病毒 SV	●	●	○	●	○
小鼠肺炎病毒 PVM	●	●	○	●	○
呼肠孤病毒Ⅲ型 Reo-3	●	●	○	●	●
小鼠微小病毒 MVM	●	●	●	●	●
汉坦病毒 HV	○	○	◎	●	○
淋巴细胞脉络丛脑膜炎病毒 LCMV	○	○	○	●	●
小鼠脑脊髓炎病毒 TMEV(GDV Ⅱ)	○	○	●	●	●
小鼠腺病毒 MDA	取消	○	○	●	●
多瘤病毒 POLY	○	○	◎	●	○
小鼠轮状病毒 RRV			●	●	●
小鼠细小病毒1&2 MPV 1 & 2			●	●	●
小鼠诺如病毒 MNV	◎		●	●	●
小鼠胸腺病毒 MTV				●	●
K病毒 K virus				●
小鼠巨细胞病毒 MCMV			◎	●	○
小鼠肾细小病毒 MKPV				●	●
乳酸脱氢酶升高病毒 LDV			◎	●	●
星状病毒 Astrovirus					○

病毒 Virus	国家标准^a National standards		FELASA^b	JAX^c	CRL^d
病毒 Virus	2022	2011	FELASA^b	JAX^c	CRL^d
鼠痘病毒 Ect.	○	●	○	●	○
小鼠肝炎病毒 MHV	●	●	●	●	●
仙台病毒 SV	●	●	○	●	○
小鼠肺炎病毒 PVM	●	●	○	●	○
呼肠孤病毒Ⅲ型 Reo-3	●	●	○	●	●
小鼠微小病毒 MVM	●	●	●	●	●
汉坦病毒 HV	○	○	◎	●	○
淋巴细胞脉络丛脑膜炎病毒 LCMV	○	○	○	●	●
小鼠脑脊髓炎病毒 TMEV(GDV Ⅱ)	○	○	●	●	●
小鼠腺病毒 MDA	取消	○	○	●	●
多瘤病毒 POLY	○	○	◎	●	○
小鼠轮状病毒 RRV			●	●	●
小鼠细小病毒1&2 MPV 1 & 2			●	●	●
小鼠诺如病毒 MNV	◎		●	●	●
小鼠胸腺病毒 MTV				●	●
K病毒 K virus				●
小鼠巨细胞病毒 MCMV			◎	●	○
小鼠肾细小病毒 MKPV				●	●
乳酸脱氢酶升高病毒 LDV			◎	●	●
星状病毒 Astrovirus					○

[1]	Yong ZHAO. Evolution and Prospects of Laboratory Animal Management: A Case Study of Shanghai's Development in the Past Decade [J]. Laboratory Animal and Comparative Medicine, 2023, 43(5): 492-503.
[2]	Huan GOU, Xinying AN, Yujia TONG, Yan WANG, Shuang YANG. Analysis on the Development Status of Laboratory Animals in Japan [J]. Laboratory Animal and Comparative Medicine, 2023, 43(2): 194-204.
[3]	Chongyang QI, Lin CHEN, Man AI, Hang XU, Housen ZHANG. Safety Management Countermeasures Based on the Status of Laboratory Animal Administrative Licensing in Jiangsu Province [J]. Laboratory Animal and Comparative Medicine, 2023, 43(1): 79-85.
[4]	Xiaying LI, Yusheng WEI, Yonglu TIAN, Wanyong PANG. A Brief Interpretation of CCAC Guide on Humane Endpoints of Animals: 2022 Edition [J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 566-571.
[5]	Jian WANG, Jin LU, Lingyun TAO, Hongkun FU, Cheng GAO, Baojin WU, Yao LI, Yufeng TAO. Analysis on the Standardized Expression of the Accredited Ability Scope for Hematology, Blood Biochemistry and Urinalysis in Laboratory Animal Clinical Testing [J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 511-517.
[6]	Huiping LI, Chujun LIANG, Weibo ZHAO. The Current Status of Laboratory Animal License Administration in Guangdong Province [J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 577-582.
[7]	Xiuqing ZHENG, Zhiqiang SHAO, Jing SONG, Yuehua ZHANG, Jinhua SU. Practice of ABSL-2 Laboratory Process Management in Universities： Xiamen University as An Example [J]. Laboratory Animal and Comparative Medicine, 2022, 42(4): 364-370.
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[12]	CHEN Lin, AI Man, XU Hang, QI Chongyang, SHI Aimin. Current Status of Administrative Licensing for Laboratory Animals in Jiangsu Province [J]. Laboratory Animal and Comparative Medicine, 2021, 41(4): 284-289.
[13]	JIANG Kun, TANG Yiwen, LIU Yanbin, CHEN Liming, TANG Hongbin. Design of Health Code Management Framework for Laboratory Animals [J]. Laboratory Animal and Comparative Medicine, 2021, 41(1): 66-69.
[14]	XU Qing-hua, TONG Lin. Application of Analytic Hierarchy Process in Biosafety Management of Laboratory Animals [J]. Laboratory Animal and Comparative Medicine, 2018, 38(4): 299-303.
[15]	SHENG Jun-jie, HU Qing-yuan, WANG Ke-zhou, LV Su-jun. An Introduction of 《Public Health Service Policy on Humane Care and Use of Laboratory Animals (Revised 2015)》 [J]. Laboratory Animal and Comparative Medicine, 2017, 37(4): 303-308.