Schulich School of Medicine and Dentistry, Western Universitygrid.39381.30, London, Ontario, Canada.
Department of Pathology and Laboratory Medicine, Western Universitygrid.39381.30, London, Ontario, Canada.
Microbiol Spectr. 2022 Jun 29;10(3):e0039922. doi: 10.1128/spectrum.00399-22. Epub 2022 May 18.
Xpert Xpress SARS-CoV-2/Flu/RSV is a rapid diagnostic test currently approved for the detection of SARS-CoV-2 using upper respiratory tract specimens. This study attempts to assess the performance of this assay using upper and lower respiratory tract specimens by comparing its results to the lab-developed PCR test. We assessed the performance of GeneXpert for the detection of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus for upper respiratory tract specimens. In addition, the SARS-CoV-2 detection was evaluated for lower respiratory tract specimens (bronchoalveolar lavage and tracheal aspirate). Precision and reproducibility of the test were also assessed using samples with varying cycle threshold values. Xpert Xpress SARS-CoV-2/Flu/RSV shows 100% positive and negative agreements for all four targets when tested using upper respiratory tract specimens. For lower respiratory tract specimens, tracheal aspirate and bronchoalveolar lavage samples respectively show 96% and 100% positive percent agreement for SARS-Cov-2 target only. No positive flu/RSV samples were included for lower respiratory tract specimens. Both samples show 100% negative percent agreement. The precision and reproducibility assay also showed 100% correspondence. Xpert Xpress SARS-CoV-2/Flu/RSV can be potentially used for SARS-Cov-2 detection in lower respiratory tract specimens. Performance passed our study acceptance criteria and shows promising implications as a point of care detection assay. Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV provides a means of rapid diagnosis that can help in hospital bed management and patient flow. It is also important for each microbiology lab to increase its capacity and most importantly have a different platform to overcome the anticipated reagent shortage at times of peak community transmission. There is limited evidence on using it for lower respiratory tract specimens. Here we present our validation for upper respiratory tract specimens as well as a potential use for lower respiratory specimens (BAL and TA), and we discuss some of the applications we have been using in our organization.
Xpert Xpress SARS-CoV-2/Flu/RSV 是一种快速诊断检测试剂,目前已获得批准,可用于检测呼吸道样本中的 SARS-CoV-2。本研究旨在通过将该检测方法的结果与实验室开发的 PCR 检测进行比较,评估其在上、下呼吸道样本中的性能。我们评估了 GeneXpert 在上呼吸道样本中检测 SARS-CoV-2、甲型流感病毒、乙型流感病毒和呼吸道合胞病毒的性能。此外,还评估了 SARS-CoV-2 在下呼吸道样本(支气管肺泡灌洗液和气管抽吸物)中的检测效果。我们还使用不同循环阈值的样本评估了该检测的精密度和重复性。使用上呼吸道样本进行检测时,Xpert Xpress SARS-CoV-2/Flu/RSV 对所有四个靶标均显示出 100%的阳性和阴性符合率。对于下呼吸道样本,气管抽吸物和支气管肺泡灌洗液样本分别仅对 SARS-CoV-2 靶标显示 96%和 100%的阳性符合率。下呼吸道样本未包括阳性流感/呼吸道合胞病毒样本。两个样本均显示 100%的阴性符合率。精密度和重复性检测也显示出 100%的一致性。Xpert Xpress SARS-CoV-2/Flu/RSV 可能可用于检测下呼吸道样本中的 SARS-CoV-2。该检测的性能通过了我们的研究接受标准,并显示出作为即时检测方法的应用前景。赛沛公司的 Xpert Xpress SARS-CoV-2/Flu/RSV 提供了一种快速诊断方法,有助于管理医院病床和患者流动。对于每个微生物学实验室来说,增加其检测能力,最重要的是拥有不同的检测平台,以应对社区传播高峰期预期的试剂短缺问题,这一点也非常重要。目前关于使用该方法检测下呼吸道样本的证据有限。本研究报告了我们在上呼吸道样本中的验证结果,以及在下呼吸道样本(支气管肺泡灌洗液和气管抽吸物)中的潜在应用,并讨论了我们在本组织中使用的一些应用。