內 容
|
一、依據衛生福利部疾病管制署115年4月2日疾管感字第1150500079號函辦理。
二、鑑於近年國際間持續出現立百病毒感染症疫情，且該疾病具高度嚴重性，我國已將其列為第五類法定傳染病。為使相關生物安全指引符合國際趨勢，爰參酌加拿大、美國疾病管制與預防中心（CDC）、歐洲疾病預防控制中心（ECDC）及世界衛生組織（WHO）等最新指引進行修訂。
三、本次修正重點如下：
（一）調整指引架構，內容分為「目的」、「病原體危險群與管理規定」、「實驗室生物安全要求」
及「參考文獻」四大項。
（二）有關立百病毒病原體及臨床檢體操作之相關規範（包含實驗室生物安全等級、個人防護裝
備、感染性生物材料操作、病毒去活化、包裝與運送、清潔消毒、廢棄物管理、溢出物處
理及緊急應變等），統一納入「實驗室生物安全要求」項下說明。
（三）考量檢驗需求及風險評估原則，針對常規臨床檢驗作業，修訂如下：
1. 經局部風險評估，且結果經單位生物安全會同意後，得於BSL-2實驗室進行。
2. 應於合格且經驗證之第二級生物安全櫃（Class II BSC）或具封閉管路系統之設備內操作。
3. 操作人員須為受過適當訓練並經授權之人員，並穿戴強化個人防護裝備。
4. 操作過程應避免非必要之開蓋、分裝及氣膠產生。
四、相關指引電子檔已公布於衛生福利部疾病管制署全球資訊網（https://www.cdc.gov.tw），路徑如下：
「首頁 ＞ 傳染病與防疫專題 ＞ 實驗室生物安全 ＞ 實驗室生物安全技術規範及指引 ＞ 3-病原體之實驗室生物安全規範及指引」，請自行下載參閱。
I. This announcement is issued in accordance with the directive No. 1150500079, dated April 2, 2026, from the Disease Control Division, Ministry of Health and Welfare.
II. In view of the ongoing outbreaks of Nipah virus infection internationally and the severity of the disease, Taiwan has classified it as a Category V notifiable infectious disease. To ensure that our biosafety guidelines remain aligned with international standards, we have revised them in reference to the latest guidance from the Canadian government, the U.S. Centers for Disease Control and Prevention (CDC), the European Centre for Disease Prevention and Control (ECDC), and the World Health Organization (WHO).
III. The key revisions in this update are as follows:
(1) The structure of the guidelines has been reorganized into four main sections: "Purpose," "Pathogen Risk Groups and Management Regulations," "Laboratory Biosafety Requirements," and "References."
(2) All regulations concerning the handling of Nipah virus pathogens and clinical specimens (including laboratory biosafety levels, personal protective equipment, handling of infectious biological materials, virus inactivation, packaging and transportation, cleaning and disinfection, waste management, spill handling, and emergency response) have been consolidated under the "Laboratory Biosafety Requirements" section.
(3) In consideration of testing requirements and risk assessment principles, the following revisions apply to routine clinical testing procedures:
1. Testing may be conducted in a Biosafety Level 2 (BSL-2) laboratory if a local risk assessment is performed and approved by the unit is biosafety committee.
2. Operations must be carried out within a certified Class II Biological Safety Cabinet (BSC) or equipment with a closed-loop system.
3. Personnel must be appropriately trained and authorized, and must wear enhanced personal protective equipment.
4. Procedures should avoid unnecessary opening, aliquoting, and aerosol generation.
IV. The electronic version of the updated guidelines has been published on the Ministry of Health and Welfare is Disease Control Division website (https://www.cdc.gov.tw). The path to access the document is as follows:
"Home > Infectious Diseases and Epidemic Prevention > Laboratory Biosafety > Laboratory Biosafety Technical Specifications and Guidelines > 3. Laboratory Biosafety Specifications and Guidelines for Pathogens." Please download and refer to the document as needed.
Sincerely,
[Your University Name]
[Date] |
|