基于暴露分析与关键控制点方法对医院开展严重急性呼吸综合征冠状病毒2型检测的可行性研究

评估2019新型冠状病毒病暴发期间在医院开展严重急性呼吸综合征冠状病毒 2 型(severe acute respiratory syndrome coronavirus 2，SARS-CoV-2)核酸检测的可行性，为最终在医院开展核酸检测提供参考。熟悉暴露分析和关键点控制(exposure analysis and critical control points，EACCP)工作框架的专业人员在基于医院现实条件下，对SARS-CoV-2检测过程中可能的感染暴露风险和途径进行梳理，建立整个检测流程，验证在配备有发热门诊的医院开展的可行性，并明确降低暴露风险的关键控制点。高风险是在发热门诊标本的采集和灭活处理，中风险是未灭活标本的储运，低风险是灭活标本的储运和检测。优化检验流程能降低检测过程中感染暴露风险，对于高风险的操作，可在生物安全二级实验室(发热门诊或移动采集点等)和相应的安全防护等级下进行操作； EACCP分析方法可用于新发感染性疾病暴发期间的管理。

Feasibility for SARS-CoV-2 tests in the hospital: an Exposure Analysis and Critical Control Points approach

This work aims to assess the feasibility of performing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA tests in hospitals and communities experiencing coronavirus disease 19 (COVID-19) outbreaks, to ultimately provide recommendations for hospitals with so-called fever clinics. In China, these specialized clinics within a hospital specifically receive outpatients with fever symptoms. A team with expertise in the Exposure Analysis and Critical Control Points (EACCP) framework identified potential infection routes during the testing for SARS-CoV-2, then constructed and tested flow diagrams, which were confirmed under actual conditions, demonstrating the feasibility to carry out in hospitals with fever clinics. The team determined critical control points to mitigate the exposure risks at each control point. The sampling and inactivation steps of clinical samples in fever clinics appeared to be associated with particularly high-risk levels of exposure to SARS-CoV-2. Moderate exposure levels were associated with storage and transportation of samples for inactivation. Low-risk levels associated with the transportation, storage, and detection steps after inactivation. To minimize infection risks for personnel, we proposed optimized processes to carry out SARS-CoV-2 RNA tests in hospitals with fever clinics in China. The high risk of SARS-CoV-2 exposure during procedures preceding testing is the sampling and biological inactivation. Simultaneously, full personal protective equipment and biosafety level-2 (BSL-2) laboratories in fever clinics or mobile BSL-2 laboratories could reduce the risk. Implementing the EACCP framework could facilitate rapid responses to outbreaks of emerging infectious diseases.