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中华诊断学电子杂志 ›› 2026, Vol. 14 ›› Issue (03) : 149 -161. doi: 10.3877/cma.j.issn.2095-655X.2026.03.001

指南与共识

高致病性真菌菌株保藏、转运、灭活与处置专家共识
中华医学会皮肤性病学分会真菌学组   
  1. 1. 海军军医大学海军特色医学中心,上海 200050
    2. 江西省肿瘤真菌感染防治院士工作站,南昌 330029
    3. 四川大学华西医院感染性疾病中心,成都 610041
    4. 上海长征医院皮肤科,上海 200003
  • 收稿日期:2026-06-02 出版日期:2026-08-26
  • 基金资助:
    国家科技重大专项(2026ZD01909306); 国家重点研发计划(2023YFC2308800); 国家自然科学基金(82674555,82302546,82272355,82472304,U25A2088)

Expert consensus on preservation, transport, inactivation, and disposal of highly pathogenic fungal strains

Fungal Study Group of the Chinese Medical Association Dermatology Branch   

  • Received:2026-06-02 Published:2026-08-26
引用本文:

中华医学会皮肤性病学分会真菌学组. 高致病性真菌菌株保藏、转运、灭活与处置专家共识[J/OL]. 中华诊断学电子杂志, 2026, 14(03): 149-161.

Fungal Study Group of the Chinese Medical Association Dermatology Branch. Expert consensus on preservation, transport, inactivation, and disposal of highly pathogenic fungal strains[J/OL]. Chinese Journal of Diagnostics(Electronic Edition), 2026, 14(03): 149-161.

高致病性真菌(皮炎芽生菌、球孢子菌属、组织胞浆菌属及副球孢子菌属等)系《人间传染的病原微生物目录》所列第二类病原微生物,随着组织病理、真菌培养、血清学、质谱鉴定及高通量测序等诊断技术在疑难感染识别中的应用增加,此类病原微生物从临床样本中被检出、分离和复核的机会增多,诊断相关阳性培养物、疑似分离株、复核菌株及剩余感染性材料的后续管理需求日益突出。由于其产孢特性、长期环境存活能力及双相转换特征使菌株保藏、转运、灭活及退出等管理环节具有显著特殊性。鉴于现行法规对保藏、转运及灭活处置仅作原则性规定,缺乏针对真菌生物学特征的技术细化。中华医学会皮肤性病学分会真菌学组联合多学科专家,在系统检索国内外法规与文献的基础上,经预调研形成候选条款池,采用改良德尔菲专家咨询法征询意见,共识形成标准为:(1)评分为4~5分(赞同/很赞同)的专家比例≥ 75%;(2)评分为1~2分(很不赞同/不赞同)的专家比例< 10%;(3)评分为3分(中立)的专家比例< 20%;(4)评分中位数≥ 4,证据等级与推荐强度参照牛津循证医学中心证据与推荐强度标准判定。最终形成9条推荐意见,涵盖生物安全防护等级3级(BSL-3)前提条件、保藏分区与容器管理、出入库核对、院内及跨单位转运、液体与固体材料灭活、泄漏应急处置、暴露后医学处置及菌株退出管理七大环节。本共识是我国首部聚焦高致病性真菌菌株保藏、出入库、操作、转运和运输、废物处置、风险管理和应急处置等管理环节的操作性技术文件,旨在将上位法要求转化为真菌专属、可执行、可核查、可追溯的技术规范,为具备相应资质并开展相关病原学诊断、复核及菌株管理的实验室提供管理依据。

Highly pathogenic fungi are classified as Category Ⅱ pathogenic microorganisms in the Catalogue of Pathogenic Microorganisms Transmissible to Humans. With the increasing use of histopathology, fungal culture, serological assays, mass spectrometry-based identification, and high-throughput sequencing in the diagnosis of difficult-to-identify infections, these pathogens are increasingly detected, isolated, and re-identified from clinical specimens, thereby creating an urgent need for standardized management of diagnosis-related positive cultures, suspected isolates, confirmed strains, and residual infectious materials. The spore-producing nature, prolonged environmental survival, and dimorphic transition confer distinctive biological characteristics that render strain preservation, transport, inactivation, and retirement management particularly challenging. Current regulations provide only general principles for preservation, transport, and inactivation, lacking technical specifications tailored to fungal biology. The Fungal Study Group of the Chinese Medical Association Dermatology Branch, in collaboration with multidisciplinary experts, systematically reviewed domestic and international regulations and literature, conducted preliminary investigations to generate a pool of candidate items, and employed a modified Delphi method to solicit expert opinions. Consensus was defined as simultaneously meeting the following four criteria: (1)≥ 75% of experts scoring 4-5 (agree/strongly agree); (2)<10% of experts scoring 1-2 (strongly disagree/disagree); (3)< 20% of experts scoring 3 (neutral); (4)a median score≥ 4. Evidence levels and recommendation strengths were graded according to the Oxford Centre for Evidence-Based Medicine criteria. Nine recommendations were ultimately formulated, covering seven domains: prerequisites for biological safety level 3 (BSL-3) laboratories, preservation zoning and container management, inbound and outbound inventory verification, intra-hospital and inter-institutional transport, liquid and solid material inactivation, emergency response to leakage, post-exposure medical management, and strain retirement and disposal. This consensus represents China′s first operational technical document specifically addressing preservation, inventory handling, operation, transport and shipping, disposal, risk management, and emergency response of highly pathogenic fungal strains. It aims to translate statutory requirements into fungal-specific, enforceable, verifiable, and traceable technical standards, providing a management framework for qualified laboratories engaged in pathogenic diagnosis, re-identification, and strain management.

图1 高致病性真菌菌株全生命周期管理与保障体系示意图注:BSL-3为生物安全防护等级3级
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