菌落总数质控样的制备及其在能力验证中的应用
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摘要
目的制备均匀性和稳定性符合能力验证要求的质控样品,并将质控样品用于菌落总数的能力验证。方法本次考核样品由高浓度(3×10~4 CFU)、低浓度(1×10~4 CFU)2个样品组成,随机抽取质控样品进行稳定性及均匀性的检验,对其进行评价。本设计通过对实验室进行随机分组来发放样品,防止能力验证活动中各实验室进行串通。结果 65家实验室参加本次考核活动,整体满意率为80%,本次能力验证可以真实地反映参试单位的检测水平。结论本次菌落总数能力验证样品可用于质控样品使用。
Objective To prepare quality control samples with uniformity and stability those meet the requirements for proficiency testing, and verify the ability of the quality control samples for the total number of colonies. Methods The test samples were composed of 2 samples with high concentration(3×10~4 CFU) and low concentration(1×10~4 CFU). Randomly selected samples were tested the stability and uniformity. This design distributed samples by randomly grouping laboratories to prevent collusion in laboratories in proficiency testing activities. Results Totally 65 laboratories participated in this proficiency test, 80% of the laboratories with excellent results. This proficiency test could truly reflect the detection level of the participating units. Conclusion This verification samples of total number of colony can be used for quality control samples.
Objective To prepare quality control samples with uniformity and stability those meet the requirements for proficiency testing, and verify the ability of the quality control samples for the total number of colonies. Methods The test samples were composed of 2 samples with high concentration(3×10~4 CFU) and low concentration(1×10~4 CFU). Randomly selected samples were tested the stability and uniformity. This design distributed samples by randomly grouping laboratories to prevent collusion in laboratories in proficiency testing activities. Results Totally 65 laboratories participated in this proficiency test, 80% of the laboratories with excellent results. This proficiency test could truly reflect the detection level of the participating units. Conclusion This verification samples of total number of colony can be used for quality control samples.
引文
[1]国家食品药品监督管理总局[EB/OL].[2019-02-07].http://samr.cfda.gov.cn/WSS01CL1667/.China Food and Drug Administration[EB/OL].[20 19-02-07].http:/samr.cfda.gov.cn/WSS1/CL1667/.
[2]GB 4789.2-2016食品微生物学检验菌落总数测定[S].B 4789.2-2016 Food microbiological examination-Aerobic plate count[S].
[3]家食品药品品督管理总局科技和标准司司.微生物检验方法食品安全全家标准实操指南[M].北京:中国医药科技出版社,2017.epartment of Science,Technology and Standards of China Food and rug Administration.Food microbiological examination,operation anual[M].Beijing:China Medical Science Presss,2017.
[4]Morton RD.Compendium of methods for the microbial examination of oods,4th ed.[M].Washington:American Public Health Association,2001.
[5]Ilva ND.Microbiological examination methods of food and water:A aboratory manual[M].Florida:CRC Presss,2013.
[6]CNAS-RL 02:2007能力验证规则[S].NAS-RL 02:2007 Rules for proficiency testing[S].
[7]ISO/IEC 17025 General requirements for the competence of testing and alibration laboratories[S].
[8]骆海朋,陈怡文,权雅茹,等.沙门氏菌质控样的研制及其在能力验证中的应用[J].中国药事,2014,28(9):995-10000.Luo HP,Chen YW,Quan YR,et al.The studies of the quality control amples of Samonella and the application in the proficiency test[J].Chin harm Aff,2014,28(9):995-10000.
[9]刘雅丹,项欣华,毛歆,等.2013-2014年食药系统食品检测能力验证动浅析[J].中国药学会第二届药物检测质量管理学术研讨会论文集,2015.Liu YD,Xiang XH,Mao X,et al.Analysis of the food proficiency testing(PT)ability in OFMCL from 2013 to 2014[C].Second Symposium on uality Management of Drug Detection by the Chinese Pharmaceutical ociety,2015.
[10]ISO/TS 22117:2010 Microbiology of food and animal feeding tuffs-Specific requirements and guidance for proficiency testing by nterlaboratory comparison[S].
[11]温朗聪,袁杰利,卢行安,等.冻干微生物与保护剂[J].中国微生态学杂志,1997,9(1):56.Wen LC,Yuan JL,Lu XA,et al.Freeze-dried microorganisms and protectors[J].Chin J Microecol,1997,9(1):56.
[12]CNAS-GL 03:2006能力验证样品均匀性和稳定性评价指南[S].CNAS-RL 03:2006 Guidelines for evaluating the homogeneity and stability of capability-verified samples[S].
[13]卢行安,郑江,曹志军,等,微生物能力验证样品均匀性试验的研究[J].中国微生态学杂志,2003,15(1):33-34.Lu XA,Zheng J,Cao ZJ,et al,The study of homogeneity of microbiological proficiency testing matrix[J].Chin J Microecol,2003,15(1):33-34.
[14]Augustin JC,Carlier V.Lessons from the organization of a proficiency testing program in food microbiology by interlaboratory comparison:Analytical methods in use,impact of methods on bacterial counts an measurement uncertainty of bacterial counts[J].Food Microbiol,2005,(23):1-38.
[15]刘淑艳,王刚,于珂,等.食品微生物多轮次能力验证方案初探[J].中国食品卫生杂志,2012,24(1):50-55.Liu SY,Wang G,Yu K,et al.A preliminary study on the foodmicrobiological multi-round proficiency testing program[J].Chin J Food Hyg,2012,24(1):50-55.
[2]GB 4789.2-2016食品微生物学检验菌落总数测定[S].B 4789.2-2016 Food microbiological examination-Aerobic plate count[S].
[3]家食品药品品督管理总局科技和标准司司.微生物检验方法食品安全全家标准实操指南[M].北京:中国医药科技出版社,2017.epartment of Science,Technology and Standards of China Food and rug Administration.Food microbiological examination,operation anual[M].Beijing:China Medical Science Presss,2017.
[4]Morton RD.Compendium of methods for the microbial examination of oods,4th ed.[M].Washington:American Public Health Association,2001.
[5]Ilva ND.Microbiological examination methods of food and water:A aboratory manual[M].Florida:CRC Presss,2013.
[6]CNAS-RL 02:2007能力验证规则[S].NAS-RL 02:2007 Rules for proficiency testing[S].
[7]ISO/IEC 17025 General requirements for the competence of testing and alibration laboratories[S].
[8]骆海朋,陈怡文,权雅茹,等.沙门氏菌质控样的研制及其在能力验证中的应用[J].中国药事,2014,28(9):995-10000.Luo HP,Chen YW,Quan YR,et al.The studies of the quality control amples of Samonella and the application in the proficiency test[J].Chin harm Aff,2014,28(9):995-10000.
[9]刘雅丹,项欣华,毛歆,等.2013-2014年食药系统食品检测能力验证动浅析[J].中国药学会第二届药物检测质量管理学术研讨会论文集,2015.Liu YD,Xiang XH,Mao X,et al.Analysis of the food proficiency testing(PT)ability in OFMCL from 2013 to 2014[C].Second Symposium on uality Management of Drug Detection by the Chinese Pharmaceutical ociety,2015.
[10]ISO/TS 22117:2010 Microbiology of food and animal feeding tuffs-Specific requirements and guidance for proficiency testing by nterlaboratory comparison[S].
[11]温朗聪,袁杰利,卢行安,等.冻干微生物与保护剂[J].中国微生态学杂志,1997,9(1):56.Wen LC,Yuan JL,Lu XA,et al.Freeze-dried microorganisms and protectors[J].Chin J Microecol,1997,9(1):56.
[12]CNAS-GL 03:2006能力验证样品均匀性和稳定性评价指南[S].CNAS-RL 03:2006 Guidelines for evaluating the homogeneity and stability of capability-verified samples[S].
[13]卢行安,郑江,曹志军,等,微生物能力验证样品均匀性试验的研究[J].中国微生态学杂志,2003,15(1):33-34.Lu XA,Zheng J,Cao ZJ,et al,The study of homogeneity of microbiological proficiency testing matrix[J].Chin J Microecol,2003,15(1):33-34.
[14]Augustin JC,Carlier V.Lessons from the organization of a proficiency testing program in food microbiology by interlaboratory comparison:Analytical methods in use,impact of methods on bacterial counts an measurement uncertainty of bacterial counts[J].Food Microbiol,2005,(23):1-38.
[15]刘淑艳,王刚,于珂,等.食品微生物多轮次能力验证方案初探[J].中国食品卫生杂志,2012,24(1):50-55.Liu SY,Wang G,Yu K,et al.A preliminary study on the foodmicrobiological multi-round proficiency testing program[J].Chin J Food Hyg,2012,24(1):50-55.