JC Wilt Infectious Diseases Research Centre, National Microbiology Laboratory Branch, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Department of Microbiology, University of Manitoba, Winnipeg, Manitoba, Canada.
Microbiol Spectr. 2024 Jul 2;12(7):e0016324. doi: 10.1128/spectrum.00163-24. Epub 2024 May 17.
Post-market surveillance of test performance is a critical function of public health agencies and clinical researchers that ensures tests maintaining diagnostic characteristics following their regulatory approval. Changes in product quality, manufacturing processes over time, or the evolution of new variants may impact product performance. During the COVID-19 pandemic, a plethora of point-of-care tests (POCTs) was released onto the Canadian market. This study evaluated the performance characteristics of several of the most widely distributed POCTs in Canada, including four rapid antigen tests (Abbott Panbio, BTNX Rapid Response, SD Biosensor, and Quidel QuickVue) and two molecular tests (Abbott ID NOW and Lucira Check IT). All tests were challenged with 149 SARS-CoV-2 clinical positives, including multiple variants up to and including Omicron XBB.1.5, as well as 29 clinical negatives. Results were stratified based on whether the isolate was Omicron or pre-Omicron as well as by reverse transcriptase quantitative PCR Ct value. The test performance of each POCT was consistent with the manufacturers' claims and showed no significant decline in clinical performance against any of the variants tested. These findings provide continued confidence in the results of these POCTs as they continue to be used to support decentralized COVID-19 testing. This work demonstrates the essential role of post-market surveillance in ensuring reliability in diagnostic tools.IMPORTANCEPost-market surveillance of diagnostic test performance is critical to ensure their reliability after regulatory approval. This is especially critical in the context of the COVID-19 pandemic as the use of point-of-care tests (POCTs) became widespread. Our study focused on four rapid antigen tests (Abbott Panbio, BTNX Rapid Response, SD Biosensor, and Quidel QuickVue) and two molecular tests (Abbott ID NOW and Lucira Check IT) that were widely distributed across Canada, assessing their performance using many SARS-CoV-2 variants, including up to Omicron subvariant XBB.1.5. Overall, we found no significant difference in performance against any variant, reinforcing confidence in their use. As concerns in test efficacy have been raised by news outlets, particularly regarding the BTNX Rapid Response, this work is even more timely and crucial. Our research offers insights into the performance of widely used COVID-19 POCTs but also highlights the necessity for post-market surveillance.
上市后监测是公共卫生机构和临床研究人员的一项关键职能，可确保在监管批准后测试保持诊断特性。随着时间的推移，产品质量和制造工艺的变化，或者新变体的出现，都可能影响产品性能。在 COVID-19 大流行期间，大量的即时检测 (POCT) 产品投放加拿大市场。本研究评估了加拿大广泛分布的几种最广泛的 POCT 的性能特征，包括四种快速抗原检测（Abbott Panbio、BTNX Rapid Response、SD Biosensor 和 Quidel QuickVue）和两种分子检测（Abbott ID NOW 和 Lucira Check IT）。所有测试均使用 149 份 SARS-CoV-2 临床阳性样本进行了挑战，包括多个变体，直至包括 Omicron XBB.1.5，以及 29 份临床阴性样本。结果根据分离株是否为 Omicron 或 Omicron 之前的变体以及逆转录定量 PCR Ct 值进行分层。每种 POCT 的检测性能均与制造商的声明一致，在针对任何测试变体时，其临床性能均未出现显著下降。这些发现为这些 POCT 在继续用于支持 COVID-19 去中心化检测时的结果提供了持续的信心。这项工作证明了上市后监测在确保诊断工具可靠性方面的重要作用。
诊断测试性能的上市后监测对于确保其在监管批准后的可靠性至关重要。在 COVID-19 大流行期间，由于即时检测 (POCT) 的广泛使用，这一点尤为关键。我们的研究集中在四种快速抗原检测（Abbott Panbio、BTNX Rapid Response、SD Biosensor 和 Quidel QuickVue）和两种分子检测（Abbott ID NOW 和 Lucira Check IT）上，这些检测在加拿大广泛分布，使用许多 SARS-CoV-2 变体评估了它们的性能，包括 Omicron 亚变体 XBB.1.5。总体而言，我们没有发现它们在对抗任何变体方面的性能有显著差异，这进一步增强了对它们的使用信心。由于新闻媒体对检测功效提出了担忧，尤其是对 BTNX Rapid Response 的担忧，因此这项工作更加及时和重要。我们的研究提供了对广泛使用的 COVID-19 POCT 性能的见解，但也强调了上市后监测的必要性。
