內 容
|
一、依據衛生福利部疾病管制署115年2月9日疾管感字第1150500017號函。
二、衛生福利部疾病管制署於嚴重特殊傳染性肺炎（COVID-19）疫情期間訂定旨揭指引，提供國內實驗室人員於操作新型冠狀病毒（以下簡稱新冠病毒）或處理與其相關之臨床檢體時得以遵循。
三、考量新冠病毒引起之COVID-19已有預防及治療方法，且WHO、美國及新加坡並已陸續調整新冠病毒之危險群等級、實驗室生物安全操作等級、包裝等級要求及運送規範等，遂修訂旨揭指引，以符合國際趨勢與實務運作需求。修正重點說明如下：
(一)涉及新冠病毒之分離、培養或增殖等程序，調整可於BSL-2、ABSL-2或以上等級實驗室進行；惟涉及以下操作行為時，應實施局部風險評估確定，評估結果並經生物安全會同意後，於BSL-3、ABSL-3或以上等級實驗室進行：
1、處理高濃度活病毒變異株。
2、針對病毒或全長新冠病毒RNA進行基因修飾以改變其毒力、傳播力或免疫逃脫能力等。
3、使用之病毒株生物特性不明或具高致病性。
4、進行10公升以上之大規模操作。
5、製備嵌合式病毒。
(二)考量純化或合成之全長新冠病毒RNA於特定實驗條件下（例如轉染或動物接種），具有回復為感染性病毒之潛在可能性，其風險高於一般不具感染性之核酸片段，爰參採加拿大規定，增訂全長新冠病毒RNA比照RG2病原體管理之要求。
(三)有關使用氣送管運輸系統（Pneumatic tube systems，PTS）進行內部運送一節，放寬針對疑似或經檢驗含有新冠病毒之臨床檢體，於對運送流程進行特定風險評估可行，且經生物安全會同意後，得以PTS運送，且使用PTS運送之人員，均已接受相關教育訓練。惟新冠病毒及全長新冠病毒RNA，仍不得使用PTS運送。
四、旨揭指引電子檔案已置於衛生福利部疾病管制署全球資訊網（網址：www.cdc.gov.tw）之「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」專區項下，請自行下載參閱。
I. In accordance with the directive No. 1150500017 issued by the Disease Control Division, Ministry of Health and Welfare on February 9, 2026.
II. During the COVID-19 pandemic, the Disease Control Division, Ministry of Health and Welfare established the aforementioned guidelines to provide domestic laboratory personnel with operational standards for handling SARS-CoV-2 (hereinafter referred to as the novel coronavirus) or related clinical specimens.
III. Given that preventive and therapeutic measures for COVID-19 have been established, and that the WHO, the United States, and Singapore have successively adjusted the risk classification of the novel coronavirus, laboratory biosafety operation levels, packaging requirements, and transportation regulations, the aforementioned guidelines have been revised to align with international trends and practical operational needs. The key points of the revisions are as follows:
(1) Procedures involving the isolation, cultivation, or propagation of the novel coronavirus may now be conducted in BSL-2, ABSL-2, or higher-level laboratories. However, for the following operations, a local risk assessment must be conducted and approved by the Institutional Biosafety Committee before proceeding in BSL-3, ABSL-3, or higher-level laboratories:
1. Handling high-concentration live virus variants.
2. Genetically modifying the virus or full-length SARS-CoV-2 RNA to alter its virulence, transmissibility, or immune evasion capabilities.
3. Using virus strains with unknown biological characteristics or high pathogenicity.
4. Conducting large-scale operations involving 10 liters or more.
5. Preparing chimeric viruses.
(2) Considering that purified or synthesized full-length SARS-CoV-2 RNA may potentially revert to an infectious virus under specific experimental conditions (e.g., transfection or animal inoculation), its risk is higher than that of non-infectious nucleic acid fragments. Therefore, following the Canadian regulations, additional requirements have been added to manage full-length SARS-CoV-2 RNA as an RG2 pathogen.
(3) Regarding the use of pneumatic tube systems (PTS) for internal transportation, the guidelines have been relaxed to allow the transport of suspected or confirmed clinical specimens containing the novel coronavirus, provided that a specific risk assessment of the transportation process is feasible and approved by the Institutional Biosafety Committee. Personnel using PTS for transportation have received relevant training. However, the novel coronavirus and full-length SARS-CoV-2 RNA may still not be transported via PTS.
IV. The electronic version of the aforementioned guidelines has been posted on the Disease Control Division, Ministry of Health and Welfare is official website (URL: www.cdc.gov.tw) under the section "Home > Infectious Diseases and Prevention > Laboratory Biosafety > Laboratory Biosafety Technical Specifications and Guidelines > 3. Laboratory Biosafety Specifications and Guidelines for Pathogens." Please download and refer to it as needed.
Respectfully,
[Department Name]
[Date] |
|