国瑞中安集团-实验室
主营产品: 医疗器械FDA认证,医疗器械FDA注册,医疗器械CE认证,NMPA注册,械字号办理,MDL认证,TGA认证
猴痘临床试验样本冷链运输要求

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(五)标本送检

标本采集后应尽快送往实验室,如果需要长途运输标本,建议采用冷冻运输方式进行保藏。

1.上送标本:病例标本先由省级及以下疾控机构进行初步检测,猴痘阳性标本送中国疾控中心病毒病所复核。省级疾控机构不具备猴痘病毒检测条件的,应立即送中国疾控中心病毒病所进行检测,样本送检单见附表。

⒉病原体及标本运输

(1)国内运输。猴痘毒株或其他潜在感染性生物材料的运输包装分类属于A类,对应的联合国编号为UN2814,包装符合国际民航组织文件Doc9284《危险品航空安全运输技术细则》的PI602分类包装要求,通过其他交通工具运输的可参照以上标准包装。猴痘毒株或其他潜在感染性材料运输应按照《可感染人类的高致病性病原微生物菌(毒)种或样本运输管理规定》(原卫生部令第45号)办理《准运证书》。

(2)国际运输。猴痘毒株或样本在国际间运输的,应规范包装,按照《出入境特殊物品卫生检疫管理规定》办理相关手续,并满足相关国家和国际相关要求。


(5) Sample submission

The samples should be sent to the laboratory as soon as possible after collection. If it is necessary to transport the samples for a long distance, it is recommended to use frozen transport for preservation.

1. Submission of samples: The case samples shall be preliminarily tested by the disease control institutions at the provincial level and below, and the monkeypox positive samples shall be submitted to the Institute of Virology, China Center for Disease Control and Prevention for review. If the provincial disease control institutions do not have the conditions for testing monkeypox virus, they should immediately send the samples to the Institute of Viral Diseases of the China Center for Disease Control and Prevention for testing. See the attached table for the sample submission form.

2. Pathogen and specimen transportation

(1) Domestic transportation. The transportation packaging classification of monkeypox virus strain or other potentially infectious biological materials belongs to Class A, the corresponding UN number is UN2814, and the packaging meets the PI602 classification packaging requirements of the ICAO document Doc9284 Technical Rules for the Safe Transport of Dangerous Goods by Air. For transportation by other means of transportation, the above standard packaging can be referred to. The transportation of monkeypox virus strains or other potentially infectious materials shall be handled in accordance with the Administrative Provisions on the Transportation of Highly Pathogenic Microorganisms (Viruses) or Samples that May Infect Human Beings (Order No. 45 of the former Ministry of Health).

(2) International transportation. If monkeypox virus strains or samples are transported internationally, they should be packed in a standardized manner, go through relevant formalities in accordance with the Provisions on the Administration of Health Quarantine of Entry Exit Special Articles, and meet relevant national and international requirements.


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