Fernandez-Pittol Mariana, Hurtado Juan Carlos, Ali Maryam, Simarro Álvar, Proaño Fadiana, Sierra Maria, Vila Jordi
Department of Clinical Microbiology, Center for Biomedical Diagnosis (CDB), Hospital Clinic-Universitat de Barcelona, Barcelona, Spain.
Department of Basic Clinical Practice, School of Medicine, University of Barcelona, Barcelona, Spain.
Microbiol Spectr. 2023 Mar 28;11(2):e0425622. doi: 10.1128/spectrum.04256-22.
Currently, a rapid detection of SARS-CoV-2 in clinical settings such as patients from emergency surgery is needed. The QuantuMDx Q-POC assay is a real-time-PCR test that was created for the rapid detection of SARS-CoV-2 in only 30 min. This study aimed to compare QuantuMDx Q-POC with our standard algorithm with Cobas 6800 for SARS-CoV-2 detection. The samples were run in parallel in both platforms. First, a comparison analysis was carried out. Second, the limit of detection was determinate in both platforms using a serial dilution of SARS-CoV-2 inactivated virus. A total of 234 samples were analyzed. For a Ct <30, the sensitivity and specificity was 100.0% and 92.5%, respectively. Positive predictive value was 86.2% and negative predictive value was 100.0%. Both COBAS 6800 and QuantuMDx Q-POC could detect up to 100 copies/mL. The QuantuMDx Q-POC system it is a reliable option when a rapid detection of SARS-CoV-2 is necessary. In different health care settings, such as patients from emergency surgery, rapid detection of SARS-CoV-2 is needed. The QuantuMDx Q-POC is an automatized fast workflow platform based on detection of three genes: two genes encoding structural proteins that can be used to differentiate SARS-CoV-2 from other coronavirus and a third target gene encoding a nonstructural region that is unique for SARS-CoV-2 such as the open reading frame (). This assay enables a rapid detection of SARS-CoV-2 with a high sensitivity in a short time frame (30 min). Therefore, QuantuMDx is a simple, rapid and easy SARS-CoV-2 detection test from direct middle nasal swabs.
目前，临床环境中需要快速检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2），如急诊手术患者。QuantuMDx Q-POC检测是一种实时聚合酶链反应（PCR）检测方法，专为在仅30分钟内快速检测SARS-CoV-2而设计。本研究旨在比较QuantuMDx Q-POC与我们使用Cobas 6800检测SARS-CoV-2的标准算法。样本在两个平台上并行检测。首先，进行了比较分析。其次，在两个平台上使用SARS-CoV-2灭活病毒的系列稀释液确定检测限。共分析了234个样本。对于Ct<30的情况，灵敏度和特异性分别为100.0%和92.5%。阳性预测值为86.2%，阴性预测值为100.0%。COBAS 6800和QuantuMDx Q-POC都能检测到高达100拷贝/毫升。当需要快速检测SARS-CoV-2时，QuantuMDx Q-POC系统是一个可靠的选择。在不同的医疗环境中，如急诊手术患者，需要快速检测SARS-CoV-2。QuantuMDx Q-POC是一个基于检测三个基因的自动化快速工作流程平台：两个编码结构蛋白的基因，可用于区分SARS-CoV-2与其他冠状病毒，以及第三个编码SARS-CoV-2独特非结构区域的靶基因，如开放阅读框（）。该检测方法能够在短时间内（30分钟）以高灵敏度快速检测SARS-CoV-2。因此，QuantuMDx是一种从直接中鼻拭子中简单、快速且易于进行的SARS-CoV-2检测方法。
