Muhi Stephen, Tayler Nick, Hoang Tuyet, Prestedge Jacqueline, Lee Jean Y H, Ballard Susan A, Isles Nicole, Wlodek Andrew, Greenhalgh Arran, Williamson Deborah A, Howden Benjamin P, Stinear Timothy P
Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia.
Access Microbiol. 2022 Apr 19;4(4):000346. doi: 10.1099/acmi.0.000346. eCollection 2022.
Australia's response to the coronavirus disease 2019 (COVID-19) pandemic relies on widespread availability of rapid, accurate testing and reporting of results to facilitate contact tracing. The extensive geographical area of Australia presents a logistical challenge, with many of the population located distant from a laboratory capable of robust severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection. A strategy to address this is the deployment of a mobile facility utilizing novel diagnostic platforms. This study aimed to evaluate the feasibility of a fully contained transportable SARS-CoV-2 testing laboratory using a range of rapid point-of-care tests.
A 20 ft (6.1 m) shipping container was refurbished (GeneWorks, Adelaide, South Australia) with climate controls, laboratory benches, hand-wash station and a class II biosafety cabinet. Portable marquees situated adjacent to the container served as stations for registration, sample acquisition and personal protective equipment for staff. Specimens were collected and tested on-site utilizing either the Abbott ID NOW or Abbott Panbio rapid tests. SARS-CoV-2 positive results from the rapid platforms or any participants reporting symptoms consistent with COVID-19 were tested on-site by GeneXpert Xpress RT-PCR. All samples were tested in parallel with a standard-of-care RT-PCR test (Panther Fusion SARS-CoV-2 assay) performed at the public health reference laboratory. In-laboratory environmental conditions and data management-related factors were also recorded.
Over a 3 week period, 415 participants were recruited for point-of-care SARS-CoV-2 testing. From time of enrolment, the median result turnaround time was 26 min for the Abbott ID NOW, 32 min for the Abbott Panbio and 75 min for the Xpert Xpress. The environmental conditions of the refurbished shipping container were found to be suitable for all platforms tested, although humidity may have produced condensation within the container. Available software enabled turnaround times to be recorded, although technical malfunction resulted in incomplete data capture.
Transportable container laboratories can enable rapid COVID-19 results at the point of care and may be useful during outbreak settings, particularly in environments that are physically distant from centralized laboratories. They may also be appropriate in resource-limited settings. The results of this pilot study confirm feasibility, although larger trials to validate individual rapid point-of-care testing platforms in this environment are required.
澳大利亚应对2019冠状病毒病（COVID-19）大流行依赖于广泛提供快速、准确的检测并报告结果，以促进接触者追踪。澳大利亚地域广阔，这带来了后勤方面的挑战，许多人口居住在距离能够可靠检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的实验室较远的地方。应对这一问题的一项策略是部署利用新型诊断平台的移动设施。本研究旨在评估使用一系列即时快速检测方法的全封闭式可运输SARS-CoV-2检测实验室的可行性。
一个20英尺（6.1米）的海运集装箱（由南澳大利亚阿德莱德的GeneWorks公司翻新）配备了气候控制设备、实验台、洗手站和一个二级生物安全柜。位于集装箱旁边的便携式帐篷用作登记、样本采集站以及为工作人员提供个人防护装备的场所。使用雅培ID NOW或雅培Panbio快速检测方法在现场采集和检测样本。快速检测平台得出的SARS-CoV-2阳性结果或任何报告有与COVID-19相符症状的参与者，均通过GeneXpert Xpress RT-PCR在现场进行检测。所有样本均与在公共卫生参考实验室进行的标准护理RT-PCR检测（Panther Fusion SARS-CoV-2检测）平行检测。还记录了实验室内部环境条件和与数据管理相关的因素。
在为期3周的时间里，招募了415名参与者进行SARS-CoV-2即时检测。从登记之时起，雅培ID NOW的中位结果周转时间为26分钟，雅培Panbio为32分钟，Xpert Xpress为75分钟。尽管湿度可能导致集装箱内部出现冷凝现象，但翻新后的海运集装箱的环境条件被发现适合所有测试平台。可用软件能够记录周转时间，不过技术故障导致数据采集不完整。
可运输的集装箱实验室能够在护理点快速得出COVID-19检测结果，在疫情爆发期间可能会很有用，特别是在距离集中式实验室较远的环境中。它们在资源有限的环境中可能也适用。尽管需要进行更大规模的试验来验证在这种环境下各个即时快速检测平台，但这项试点研究的结果证实了其可行性。
