Bharucha Tehmina, Gangadharan Bevin, Clarke Rebecca, Fernandez Laura Gomez, Arman Benediktus Yohan, Walsby-Tickle John, Deats Michael, Mosca Sara, Lin Qianqi, Stokes Robert, Dunachie Susanna, Merchant Hamid A, Dubot-Pérès Audrey, Caillet Céline, McCullagh James, Matousek Pavel, Zitzmann Nicole, Newton Paul N
Department of Biochemistry, University of Oxford, Oxford OX1 3QU, UK; Kavli Institute for Nanoscience Discovery, University of Oxford, Oxford OX1 3QU, UK; Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao Democratic People's Republic.
Department of Biochemistry, University of Oxford, Oxford OX1 3QU, UK; Kavli Institute for Nanoscience Discovery, University of Oxford, Oxford OX1 3QU, UK.
Vaccine. 2024 Mar 7;42(7):1506-1511. doi: 10.1016/j.vaccine.2024.01.019. Epub 2024 Feb 14.
Substandard (including degraded) and falsified (SF) vaccines are a relatively neglected issue with serious global implications for public health. This has been highlighted during the rapid and widespread rollout of COVID-19 vaccines. There has been increasing interest in devices to screen for SF non-vaccine medicines including tablets and capsules to empower inspectors and standardise surveillance. However, there has been very limited published research focussed on repurposing or developing new devices for screening for SF vaccines. To our knowledge, rapid diagnostic tests (RDTs) have not been used for this purpose but have important potential for detecting falsified vaccines. We performed a proof-in-principle study to investigate their diagnostic accuracy using a diverse range of RDT-vaccine/falsified vaccine surrogate pairs. In an initial assessment, we demonstrated the utility of four RDTs in detecting seven vaccines. Subsequently, the four RDTs were evaluated by three blinded assessors with seven vaccines and four falsified vaccines surrogates. The results provide preliminary data that RDTs could be used by multiple international organisations, national medicines regulators and vaccine manufacturers/distributors to screen for falsified vaccines in supply chains, aligned with the WHO global 'Prevent, Detect and Respond' strategy.
不合格（包括变质）和伪造的（SF）疫苗是一个相对被忽视的问题，对全球公共卫生具有严重影响。在新冠疫苗迅速广泛推广期间，这一问题凸显出来。人们对用于筛查SF非疫苗药品（包括片剂和胶囊）的设备越来越感兴趣，以增强检查人员的能力并规范监测。然而，针对重新利用或开发用于筛查SF疫苗的新设备的已发表研究非常有限。据我们所知，快速诊断测试（RDT）尚未用于此目的，但在检测伪造疫苗方面具有重要潜力。我们进行了一项原理验证研究，使用多种RDT-疫苗/伪造疫苗替代对来研究其诊断准确性。在初步评估中，我们证明了四种RDT在检测七种疫苗方面的效用。随后，由三名盲法评估人员使用七种疫苗和四种伪造疫苗替代物对这四种RDT进行了评估。结果提供了初步数据，表明RDT可被多个国际组织、国家药品监管机构和疫苗制造商/经销商用于筛查供应链中的伪造疫苗，这与世界卫生组织的全球“预防、检测和应对”战略相一致。
