Phoeung Chan Leakhena, Prestedge Jacqueline, Ninan Marilyn, Cunningham Philip, Bory Sothavireak, Seang Kennarey, Heng Kanika, Williamson Deborah, Markby Jessica, Valley Andrew, Kaldor John, Saphonn Vonthanak
University of Health Sciences, Phnom Penh, Cambodia
The Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia.
BMJ Open Qual. 2025 Jan 6;14(1):e002999. doi: 10.1136/bmjoq-2024-002999.
Rapid antigen diagnostic tests (Ag-RDTs) that quickly and accurately identify SARS-CoV-2 are an essential part of the COVID-19 response, but multiple factors can affect the validity of Ag-RDTs results. In Cambodia, several commercial Ag-RDTs have become available since the COVID-19 outbreak, but quality control (QC) and external quality assurance (EQA) of these rapid tests have yet to be fully and systematically implemented. We collaborated with laboratory experts in Australia and piloted an EQA programme of the commonly used COVID-19 Ag-RDTs at the University of Health Sciences' MERIEUX Laboratory (Tier 1 site-responsible for the in-country receipt and distribution of QA material) and four other participating laboratories (Tier 2-healthcare facility based) between November 2021 and November 2022. The preimplementation training including the Khmer-translated documentation was conducted virtually for Tier 1 laboratories and in-person for Tier 2 laboratories. All QC (n=290) and EQA (n=60) specimens were distributed to the laboratories and testing was performed according to the frequency of Ag-RDTs use in each laboratory. All National Reference Laboratory-provided EQA and QC specimens were tested and results were submitted via the EDCNet portal using QR code scanning. The Tier 1 laboratory reported 100% concordance with the EQA reference result, while some of Tier 2 laboratories' results were discordant. While continued capacity building and support with troubleshooting have been key to the successful EQA piloting at the UHS laboratory, the programme experienced delays in the shipping/delivery of EQA and QC panels due to customs and border requirements, which could have hindered implementation and potentially impacted the quality of the QA materials. The pilot EQA programme demonstrated potential scalability and provided data on the reliability of test results at the site. However, to ensure sustainability and practicability of this activity, in-country EQA panel preparation may need to be considered.
能够快速准确识别严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的快速抗原诊断检测（Ag-RDTs）是应对2019冠状病毒病（COVID-19）的重要组成部分，但多种因素会影响Ag-RDTs结果的有效性。自COVID-19疫情爆发以来，柬埔寨已有多种商用Ag-RDTs可供使用，但这些快速检测的质量控制（QC）和外部质量保证（EQA）尚未得到全面系统的实施。2021年11月至2022年11月期间，我们与澳大利亚的实验室专家合作，在健康科学大学的梅里埃实验室（一级站点，负责国内质量保证材料的接收和分发）和其他四个参与实验室（二级，基于医疗机构）开展了常用COVID-19 Ag-RDTs的EQA项目试点。针对一级实验室进行了虚拟的包括高棉语翻译文档的实施前培训，对二级实验室进行了现场培训。所有质量控制（n=290）和外部质量保证（n=60）样本被分发给各实验室，并根据每个实验室使用Ag-RDTs的频率进行检测。所有由国家参考实验室提供的外部质量保证和质量控制样本均经过检测，结果通过二维码扫描经EDCNet门户提交。一级实验室报告的结果与外部质量保证参考结果的一致性为100%，而一些二级实验室的结果不一致。虽然持续开展能力建设以及提供故障排除支持是健康科学大学实验室成功进行外部质量保证试点的关键，但由于海关和边境要求，该项目在外部质量保证和质量控制样本板的运输/交付方面出现延迟，这可能会阻碍实施，并可能影响质量保证材料的质量。试点外部质量保证项目展示了潜在的可扩展性，并提供了现场检测结果可靠性的数据。然而，为确保这项活动的可持续性和实用性，可能需要考虑在国内制备外部质量保证样本板。
