Baclig Michael O
Research and Biotechnology Group, Center for Basic Science Research, St. Luke's Medical Center, Quezon City, Philippines.
St. Luke's Medical Center College of Medicine-WHQM, Quezon City, Philippines.
Appl Biosaf. 2021 Sep;26(Suppl 1):S10-S15. doi: 10.1089/apb.20.0069. Epub 2021 Sep 13.
The coronavirus disease 2019 (COVID-19) that begun in December 2019 has spread worldwide and is caused by a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). In the Philippines, the first case of COVID-19 was reported on January 20, 2020. Early in the SARS-CoV2 outbreak, clinical samples from suspected COVID-19 patients had to be sent to a reference laboratory in Australia for confirmation. However, as of November 11, 2020, there are now 164 Department of Health (DOH) licensed COVID-19 testing laboratories in the country. The Department of Health-Research Institute for Tropical Medicine (DOH-RITM) is the National Reference Laboratory for emerging and re-emerging infectious diseases. The RITM follows the guidelines set forth by the World Health Organization (WHO) when responding to outbreaks. One of its functions is to conduct risk assessment and proficiency testing to ensure and maintain the safety and high-quality performance of independent laboratories. The majority of the COVID-19 testing centers use a real-time reverse transcription-polymerase chain reaction platform. As of November 14, 2020, there are >404,000 confirmed cases of COVID-19 in the Philippines of which 83% are mild cases. It is worthwhile to mention that before full-scale implementation and issuance of a license to operate a COVID-19 testing regimen, both hospital and nonhospital-based diagnostic laboratories undergo a multistage process for COVID-19 laboratory assessment. The requirements prescribed in the DOH assessment tool for licensing a COVID-19 testing laboratory include but are not limited to the availability of safety equipment and trained laboratory personnel, the facility must be a BSL-2 laboratory, and must have an updated protocol including a biosafety manual. In this article, the biosafety concerns associated with establishing a COVID-19 testing laboratory and running COVID-19 clinical samples will be highlighted. In addition, mitigation control measures that can be put into place for aerosol-generating procedures and key performance indicators will also be identified.
2019年12月开始的2019冠状病毒病（COVID-19）已在全球传播，它由一种名为严重急性呼吸综合征冠状病毒2（SARS-CoV2）的新型冠状病毒引起。在菲律宾，2020年1月20日报告了首例COVID-19病例。在SARS-CoV2疫情初期，疑似COVID-19患者的临床样本必须送往澳大利亚的一家参考实验室进行确认。然而，截至2020年11月11日，该国现在有164家获得卫生部（DOH）许可的COVID-19检测实验室。卫生部热带医学研究所（DOH-RITM）是新兴和再发传染病的国家参考实验室。RITM在应对疫情时遵循世界卫生组织（WHO）制定的指南。其职能之一是进行风险评估和能力验证，以确保并维持独立实验室的安全性和高质量运行。大多数COVID-19检测中心使用实时逆转录-聚合酶链反应平台。截至2日14日，菲律宾有超过40.4万例COVID-19确诊病例，其中83%为轻症病例。值得一提的是，在全面实施并发放COVID-19检测方案的运营许可之前，医院和非医院诊断实验室都要经过一个针对COVID-19实验室评估的多阶段流程。卫生部用于COVID-19检测实验室许可的评估工具规定的要求包括但不限于安全设备的可用性和经过培训的实验室人员，该设施必须是生物安全2级实验室，并且必须有包括生物安全手册在内的更新方案。在本文中，将重点介绍与建立COVID-19检测实验室和处理COVID-19临床样本相关的生物安全问题。此外，还将确定可针对产生气溶胶的操作实施的缓解控制措施和关键绩效指标。
