A Retrospective Study on Proficiency Testing Samples in the Field of Laboratory Animal Testing from 2013 to 2022

doi:10.12300/j.issn.1674-5817.2022.139

Abstract

Abstract:

Objective To analyze the status of proficiency testing samples in the field of laboratory animal testing, and to evaluate the role of the testing samples in the laboratory animal laboratory proficiency testing program. Methods A retrospective study was conducted to compare the 30 proficiency testing plans and reports in the field of laboratory animal organized by National Institute for Food and Drug Control (NIFDC) from 2013 to 2022. The type, quantity, preparation method, homogeneity and stability of the proficiency testing samples, as well as the satisfaction of the participating units to the samples were analyzed. Then, the supply of new samples, the addition of quantitative projects, the improvement of stability research and the attention to customer needs were discussed. Results The 30 proficiency testing programs included 10 items in the direction of bacteria, 10 items in the direction of virus and 10 items in the direction of genetics in the field of experimental animals. A total of 80 non-nucleic acid samples (including serums, feces, tracheal flushing fluid and proteins) and 4 nucleic acid samples were provided, all of which were qualitative samples. Compared with nucleic acid samples, non-nucleic acid samples always required large numbers of animals for sample preparation. The pass rate of homogeneity verification of the sample was 100%, but there is no quantitative study at present. Stability verification can be conducted for the short-term storage, transportation, freeze-thaw, different concentrations and terminal stability of different samples, but it lacks long-term stability verification. Conclusion In the past ten years, the proficiency testing samples have basically met the basic requirements of the proficiency testing plan of laboratory animal testing area. However, the provision of nucleic acid samples should be reasonably increased; quantitative research samples and projects should be added; the influence of proficiency testing in the field of laboratory animal testing should be continuously expanded and maintain high-quality services.

Key words: Laboratory animal, Proficiency testing, Samples, Homogeneity, Stability

CLC Number:

Q95-33

Han QIAO,Jie WEI,Feifei WANG,et al. A Retrospective Study on Proficiency Testing Samples in the Field of Laboratory Animal Testing from 2013 to 2022[J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 483-489. DOI: 10.12300/j.issn.1674-5817.2022.139.

Figures/Tables 2

References 15

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检测方向 Detection direction	年份 Year	项目名称 Item name	项目编号 Number	样品来源 Sample source	样品种类 Sample type	检测方法 Detection method
细菌 Bacterial	2013	实验动物粪便中绿脓杆菌检测	NIFDC-PT-008	粪便	4	分离培养
	2014	实验动物粪便中金黄色葡萄球菌检测	NIFDC-PT-020	粪便	3
	2015	实验动物粪便中沙门氏菌检测	NIFDC-PT-037	粪便	3
	2016	实验动物粪便中肺炎克雷伯杆菌的检测	NIFDC-PT-085	粪便	3
	2017	实验动物呼吸道样品中支气管鲍特杆菌的检测	NIFDC-PT-107	气管冲洗液	3
	2018	实验动物肠道中小肠结肠炎耶尔森菌检测	NIFDC-PT-173	粪便	3
	2019	实验动物粪便中金黄色葡萄球菌和沙门菌检测	NIFDC-PT-203	粪便	5
	2020	实验动物粪便中肺炎克雷伯杆菌检测	NIFDC-PT-281	粪便	3
	2021	实验动物样品中呼吸道病原菌（支气管鲍特杆菌、嗜肺巴斯德杆菌）的检测	NIFDC-PT-309	气管冲洗液	3
	2022	实验动物样品中鼠棒状杆菌和多杀巴斯德杆菌检测	NIFDC-PT-363	气管冲洗液	3
病毒 Viral	2013	实验大鼠细小病毒H-1株抗体检测	NIFDC-PT-007	动物血清	3	ELISA/IFA
	2014	实验兔血清中兔出血症病毒抗体检测	NIFDC-PT-019	动物血清	3
	2015	实验小鼠血清中呼肠孤病毒Ⅲ型抗体检测	NIFDC-PT-036	动物血清	3
	2016	实验大鼠血清中仙台病毒抗体检测	NIFDC-PT-084	动物血清	3
	2017	实验兔血清中仙台病毒抗体的检测	NIFDC-PT-108	动物血清	3
	2018	实验小鼠血清中小鼠细小病毒抗体检测	NIFDC-PT-172	动物血清	3
	2019	实验动物血清中大鼠仙台病毒抗体和小鼠肝炎病毒抗体检测	NIFDC-PT-201	动物血清	3
	2020	实验兔血清中仙台病毒抗体检测	NIFDC-PT-282	动物血清	3
	2021	实验小鼠血清中呼肠孤病毒Ⅲ型抗体检测	NIFDC-PT-311	动物血清	3
	2022	实验猪样品中猪细小病毒核酸检测	NIFDC-PT-364	核酸样品	2	PCR/RT-PCR
遗传 Genetic	2013	实验小鼠肾匀浆中碱性磷酸酶-1检测	NIFDC-PT-009	组织匀浆	2	同工酶染色
	2014	实验小鼠肾匀浆中酯酶-3检测	NIFDC-PT-021	组织匀浆	3
	2015	实验小鼠肾匀浆中苹果酸酶-1 和异柠檬酸脱氢酶-1 的检测	NIFDC-PT-038	组织匀浆	2
	2016	实验小鼠血清中酯酶-1的检测	NIFDC-PT-086	动物血清	2
	2017	实验小鼠肾匀浆中肽酶-3的检测	NIFDC-PT-106	组织匀浆	2
	2018	实验小鼠肾匀浆中过氧化氢酶-2的检测	NIFDC-PT-171	组织匀浆	2
	2019	实验小鼠血清中酯酶-1和转铁蛋白检测	NIFDC-PT-202	动物血清	2
	2020	实验小鼠肾匀浆中苹果酸酶-1和异柠檬酸脱氢酶-1检测	NIFDC-PT-283	组织匀浆	3
	2021	实验小鼠肾匀浆中肽酶-3检测	NIFDC-PT-310	组织匀浆	2
	2022	实验小鼠DNA样品SNP标记检测	NIFDC-PT-365	核酸样品	2	核酸测序

检测方向 Detection direction	年份 Year	项目名称 Item name	项目编号 Number	样品来源 Sample source	样品种类 Sample type	检测方法 Detection method
细菌 Bacterial	2013	实验动物粪便中绿脓杆菌检测	NIFDC-PT-008	粪便	4	分离培养
	2014	实验动物粪便中金黄色葡萄球菌检测	NIFDC-PT-020	粪便	3
	2015	实验动物粪便中沙门氏菌检测	NIFDC-PT-037	粪便	3
	2016	实验动物粪便中肺炎克雷伯杆菌的检测	NIFDC-PT-085	粪便	3
	2017	实验动物呼吸道样品中支气管鲍特杆菌的检测	NIFDC-PT-107	气管冲洗液	3
	2018	实验动物肠道中小肠结肠炎耶尔森菌检测	NIFDC-PT-173	粪便	3
	2019	实验动物粪便中金黄色葡萄球菌和沙门菌检测	NIFDC-PT-203	粪便	5
	2020	实验动物粪便中肺炎克雷伯杆菌检测	NIFDC-PT-281	粪便	3
	2021	实验动物样品中呼吸道病原菌（支气管鲍特杆菌、嗜肺巴斯德杆菌）的检测	NIFDC-PT-309	气管冲洗液	3
	2022	实验动物样品中鼠棒状杆菌和多杀巴斯德杆菌检测	NIFDC-PT-363	气管冲洗液	3
病毒 Viral	2013	实验大鼠细小病毒H-1株抗体检测	NIFDC-PT-007	动物血清	3	ELISA/IFA
	2014	实验兔血清中兔出血症病毒抗体检测	NIFDC-PT-019	动物血清	3
	2015	实验小鼠血清中呼肠孤病毒Ⅲ型抗体检测	NIFDC-PT-036	动物血清	3
	2016	实验大鼠血清中仙台病毒抗体检测	NIFDC-PT-084	动物血清	3
	2017	实验兔血清中仙台病毒抗体的检测	NIFDC-PT-108	动物血清	3
	2018	实验小鼠血清中小鼠细小病毒抗体检测	NIFDC-PT-172	动物血清	3
	2019	实验动物血清中大鼠仙台病毒抗体和小鼠肝炎病毒抗体检测	NIFDC-PT-201	动物血清	3
	2020	实验兔血清中仙台病毒抗体检测	NIFDC-PT-282	动物血清	3
	2021	实验小鼠血清中呼肠孤病毒Ⅲ型抗体检测	NIFDC-PT-311	动物血清	3
	2022	实验猪样品中猪细小病毒核酸检测	NIFDC-PT-364	核酸样品	2	PCR/RT-PCR
遗传 Genetic	2013	实验小鼠肾匀浆中碱性磷酸酶-1检测	NIFDC-PT-009	组织匀浆	2	同工酶染色
	2014	实验小鼠肾匀浆中酯酶-3检测	NIFDC-PT-021	组织匀浆	3
	2015	实验小鼠肾匀浆中苹果酸酶-1 和异柠檬酸脱氢酶-1 的检测	NIFDC-PT-038	组织匀浆	2
	2016	实验小鼠血清中酯酶-1的检测	NIFDC-PT-086	动物血清	2
	2017	实验小鼠肾匀浆中肽酶-3的检测	NIFDC-PT-106	组织匀浆	2
	2018	实验小鼠肾匀浆中过氧化氢酶-2的检测	NIFDC-PT-171	组织匀浆	2
	2019	实验小鼠血清中酯酶-1和转铁蛋白检测	NIFDC-PT-202	动物血清	2
	2020	实验小鼠肾匀浆中苹果酸酶-1和异柠檬酸脱氢酶-1检测	NIFDC-PT-283	组织匀浆	3
	2021	实验小鼠肾匀浆中肽酶-3检测	NIFDC-PT-310	组织匀浆	2
	2022	实验小鼠DNA样品SNP标记检测	NIFDC-PT-365	核酸样品	2	核酸测序

检测方向 Detection direction	项目编号 Number	存放稳定性条件 Storage stability		运输稳定性条件 Transportation stability
检测方向 Detection direction	项目编号 Number	温度Temperature/℃	周期Period/d	运输稳定性条件 Transportation stability
细菌 Bacterial	NIFDC-PT-008	37、RT、4、-20、-80	30	无
	NIFDC-PT-020	37、RT、4、-20、-80	30	无
	NIFDC-PT-037	37、RT、4、-20、-80	30	无
	NIFDC-PT-085	37、RT、4	30	无
	NIFDC-PT-107	37、RT、4、-20、-80	30	无
	NIFDC-PT-173	37、RT、4、-20	30	无
	NIFDC-PT-203	37、RT、4、-20	30	有
	NIFDC-PT-281	37、RT、4、-20、-80	30	有
	NIFDC-PT-309	37、RT、4、-20、-80	30	有
	NIFDC-PT-363	37、RT、4、-20、-80	30	有
病毒 Viral	NIFDC-PT-007	37、4、-70	15	无
	NIFDC-PT-019	37、-70	4	无
	NIFDC-PT-036	37、4、-70	15	无
	NIFDC-PT-084	37、4、-70	15	无
	NIFDC-PT-108	37、4、-70	15	无
	NIFDC-PT-172	37、4、-70	15	无
	NIFDC-PT-201	37、4、-70	15	有
	NIFDC-PT-282	37、4、-70	15	有
	NIFDC-PT-311	37、4、-70	15	有
	NIFDC-PT-364	37、4、-70	15	有
遗传 Genetic	NIFDC-PT-009	37、RT、4、-20	30	无
	NIFDC-PT-021	37、RT、4	90	无
	NIFDC-PT-038	37、RT、4、-20	28	无
	NIFDC-PT-086	RT、4	30	无
	NIFDC-PT-106	37、RT、4、-20	28	无
	NIFDC-PT-171	37、RT、4	30	有
	NIFDC-PT-202	37、RT、4、-20	50	有
	NIFDC-PT-283	37、RT、4	21	有
	NIFDC-PT-310	37、RT、4、-20	30	有
	NIFDC-PT-365	37、RT、4	14	有

检测方向 Detection direction	项目编号 Number	存放稳定性条件 Storage stability		运输稳定性条件 Transportation stability
检测方向 Detection direction	项目编号 Number	温度Temperature/℃	周期Period/d	运输稳定性条件 Transportation stability
细菌 Bacterial	NIFDC-PT-008	37、RT、4、-20、-80	30	无
	NIFDC-PT-020	37、RT、4、-20、-80	30	无
	NIFDC-PT-037	37、RT、4、-20、-80	30	无
	NIFDC-PT-085	37、RT、4	30	无
	NIFDC-PT-107	37、RT、4、-20、-80	30	无
	NIFDC-PT-173	37、RT、4、-20	30	无
	NIFDC-PT-203	37、RT、4、-20	30	有
	NIFDC-PT-281	37、RT、4、-20、-80	30	有
	NIFDC-PT-309	37、RT、4、-20、-80	30	有
	NIFDC-PT-363	37、RT、4、-20、-80	30	有
病毒 Viral	NIFDC-PT-007	37、4、-70	15	无
	NIFDC-PT-019	37、-70	4	无
	NIFDC-PT-036	37、4、-70	15	无
	NIFDC-PT-084	37、4、-70	15	无
	NIFDC-PT-108	37、4、-70	15	无
	NIFDC-PT-172	37、4、-70	15	无
	NIFDC-PT-201	37、4、-70	15	有
	NIFDC-PT-282	37、4、-70	15	有
	NIFDC-PT-311	37、4、-70	15	有
	NIFDC-PT-364	37、4、-70	15	有
遗传 Genetic	NIFDC-PT-009	37、RT、4、-20	30	无
	NIFDC-PT-021	37、RT、4	90	无
	NIFDC-PT-038	37、RT、4、-20	28	无
	NIFDC-PT-086	RT、4	30	无
	NIFDC-PT-106	37、RT、4、-20	28	无
	NIFDC-PT-171	37、RT、4	30	有
	NIFDC-PT-202	37、RT、4、-20	50	有
	NIFDC-PT-283	37、RT、4	21	有
	NIFDC-PT-310	37、RT、4、-20	30	有
	NIFDC-PT-365	37、RT、4	14	有

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