病毒学报

生物技术快速发展背景下，生物安全风险日趋复杂，传统病原微生物实验室安全监管在全面性、可信性与时效性上存在不足。本研究为提升监管效能、保障实验室安全运行，探索区块链技术的创新应用。本研究通过收集整理WHO、中美疾控中心等机构数据及相关法规和文献报道，结合案例分析法剖析欧盟2023年区块链设备数据存证、中国海关总署2023年区块链溯源技术应用等案例，论证区块链技术优势。结果表明，病原微生物实验室存在设备故障、人为失误、样本运输泄漏等风险，传统人工监管数字化程度低、数据不可靠；区块链的去中心化、不可篡改性可适配多类监管场景，据此构建的“国家-省-实验室”三级协同监管体系在粤浙试点成效显著，安全事件发生率降67%、数据上报延迟≤1min，但仍面临涉密传输、管理推广等难题。本研究为实验室安全监管提供技术新思路，对提升生物安全治理能力有参考价值。

With the rapid advancement of biotechnology, biosafety risks have become increasingly complex. Traditional safety supervision systems for pathogenic microorganism laboratories show deficiencies in comprehensiveness, credibility, and timeliness. To enhance regulatory effectiveness and ensure the safe operation of laboratories, this study explores the innovative applications of blockchain technology. Using document analysis, data were collected from organizations such as the World Health Organization(WHO), the Chinese Center for Disease Control and Prevention(China CDC), and the U.S. Centers for Disease Control and Prevention(CDC), as well as from relevant literature and regulatory frameworks. Combined with case studies— including the European Union's 2023 blockchain-based equipment data certification initiative and the 2023 blockchain traceability system implemented by China's General Administration of Customs—the advantages of blockchain technology were examined in biosafety regulation. Results indicate that pathogenic microorganism laboratories face risks such as equipment failure, human error, and sample leakage during transport. Traditional manual supervision remains limited by low levels of digitalization and unreliable data. The decentralization and immutability of blockchain can be effectively adapted to multiple regulatory scenarios. Based on these characteristics, a “national– provincial– laboratory” three-level collaborative supervision framework was developed and piloted in Guangdong and Zhejiang provinces,China, achieving significant results: the incidence of safety incidents decreased by 67%, and data reporting delays were reduced to ≤ 1 minute. However, challenges remain in secure information transmission and system scalability. This study provides a novel technical pathway for strengthening biosafety supervision in biological laboratories and offers valuable insights for improving the governance capacity of national biosafety systems.