Rebbapragada Anu, Cariazo Lane, Elchuk David, Abdelrahman Hossam, Pham Dang, Raveendraraj Jerusha, Chokshi Killol, Joseph Nirochile, Gouzenkova Elena, Gill Harpreet, Blecher Peter
FH Health , Toronto, Ontario, Canada.
Microbiol Spectr. 2023 Sep 20;11(5):e0406422. doi: 10.1128/spectrum.04064-22.
The COVID-19 pandemic highlighted the critical need for rapid and accurate molecular diagnostic testing. The Cue COVID-19 Point-of-Care Test (Cue POCT) is a nucleic acid amplification test (NAAT), authorized by Health Canada and FDA as a POCT for SARS-CoV-2 detection. Cue POCT was deployed at a network of clinics in Ontario, Canada with = 13,848 patrons tested between 17 July 2021 and 31 January 2022. The clinical performance and operational experience with Cue POCT were examined for this testing population composed mostly of asymptomatic individuals (93.7%). A head-to-head prospective clinical verification was performed between 17 July and 4 October for all POCT service clients ( = 3,037) with paired COVID-19 testing by Cue and RT-PCR. Prospective verification demonstrated a clinical sensitivity of 100% and clinical specificity of 99.4% for Cue COVID-19 POCT. The lack of false negatives and low false positive rate (0.64%), underscores the high accuracy (99.4%) of Cue POCT to provide rapid PCR quality results. Low error rates (cancellation rate of 0% and invalid rate of 0.63%) with the current software version were additionally noted. Taken together, these findings highlight the value of accurate molecular COVID-19 POCT in a distributed service delivery model to rapidly detect cases in the community with the potential to curb transmission in high-exposure settings (i.e., in-flight, congregate workplace, and social events). The insights gleaned from this operational implementation are readily transferable to future POCT diagnostic services. IMPORTANCE This manuscript reports on the findings of a large asymptomatic population who underwent surveillance COVID testing on the Cue COVID-19 Point-of-Care Test (POCT). Review of test performance of this rapid molecular POCT, as compared to gold standard RT-PCR, is valuable to many audiences, including public health, emergency testing services, employers, and the general population of consumers who are seeking a user-friendly, accurate, cost-effective, and sustainable testing model for COVID screening. The findings from this operational experience also inform future models of POCT services beyond COVID.
新冠疫情凸显了快速、准确的分子诊断检测的迫切需求。Cue新冠即时检测（Cue POCT）是一种核酸扩增检测（NAAT），已获得加拿大卫生部和美国食品药品监督管理局授权，作为一种用于检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的即时检测。Cue POCT在加拿大安大略省的一个诊所网络中使用，在2021年7月17日至2022年1月31日期间，对13848名顾客进行了检测。针对这个主要由无症状个体（93.7%）组成的检测人群，研究了Cue POCT的临床性能和操作经验。在7月17日至10月4日期间，对所有即时检测服务客户（n = 3037）进行了Cue检测与逆转录聚合酶链反应（RT-PCR）配对的新冠检测的直接前瞻性临床验证。前瞻性验证显示，Cue新冠即时检测的临床敏感性为100%，临床特异性为99.4%。没有假阴性结果且假阳性率较低（0.64%），这突出了Cue POCT提供快速PCR质量结果的高准确性（99.4%）。另外还注意到，当前软件版本的错误率较低（取消率为0%，无效率为0.63%）。综上所述，这些发现凸显了准确的分子新冠即时检测在分布式服务提供模式中的价值，能够在社区中快速检测病例，有可能在高暴露环境（即飞行途中、聚集性工作场所和社交活动）中遏制传播。从这次实际操作实施中获得的见解很容易应用于未来的即时检测诊断服务。重要性 本手稿报告了一大群无症状人群使用Cue新冠即时检测（POCT）进行监测新冠检测的结果。将这种快速分子即时检测的检测性能与金标准RT-PCR进行比较，对许多受众都有价值，包括公共卫生、应急检测服务、雇主以及寻求一种用户友好、准确、经济高效且可持续的新冠筛查检测模式的普通消费者群体。这次实际操作经验的结果也为新冠之外的即时检测服务未来模式提供了参考。
