Cassidy Hayley, van Genne Mart, Lizarazo-Forero Erley, Niesters Hubert G M, Gard Lilli
Division of Clinical Virology, Department of Medical Microbiology and Infection Prevention, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Front Microbiol. 2022 Mar 24;13:854209. doi: 10.3389/fmicb.2022.854209. eCollection 2022.
Point-of-care syndromic panels allow for simultaneous and rapid detection of respiratory pathogens from nasopharyngeal swabs. The clinical performance of the QIAstat-Dx Respiratory SARS-CoV-2 panel RP2.0 (QIAstat-Dx RP2.0) and the BioFire FilmArray Respiratory panel RP2.1 (BioFire RP2.1) was evaluated for the detection of SARS-CoV-2 and other common respiratory pathogens. A total of 137 patient samples were retrospectively selected based on emergency department admission, along with 33 SARS-CoV-2 positive samples tested using a WHO laboratory developed test. The limit of detection for SARS-CoV-2 was initially evaluated for both platforms. The QIAstat-Dx RP2.0 detected SARS-CoV-2 at 500 copies/mL and had a positive percent agreement (PPA) of 85%. The BioFire RP2.1 detected SARS-CoV-2 at 50 copies/mL and had a PPA of 97%. Both platforms showed a negative percent agreement of 100% for SARS-CoV-2. Evaluation of analytical specificity from a range of common respiratory targets showed a similar performance between each platform. The QIAstat-Dx RP2.0 had an overall PPA of 82% (67-100%) in clinical samples, with differences in sensitivity depending on the respiratory target. Both platforms can be used to detect acute cases of SARS-CoV-2. While the QIAstat-Dx RP2.0 is suitable for detecting respiratory viruses within a clinical range, it has less analytical and clinical sensitivity for SARS-CoV-2 compared to the BioFire RP2.1.
即时护理症状检测板可同时快速检测鼻咽拭子中的呼吸道病原体。对QIAstat-Dx呼吸道SARS-CoV-2检测板RP2.0（QIAstat-Dx RP2.0）和BioFire FilmArray呼吸道检测板RP2.1（BioFire RP2.1）检测SARS-CoV-2和其他常见呼吸道病原体的临床性能进行了评估。根据急诊科入院情况，共回顾性选取了137份患者样本，以及33份使用世界卫生组织实验室开发的检测方法检测为SARS-CoV-2阳性的样本。首先对两个平台检测SARS-CoV-2的检测限进行了评估。QIAstat-Dx RP2.0在500拷贝/毫升时可检测到SARS-CoV-2，阳性百分一致性（PPA）为85%。BioFire RP2.1在50拷贝/毫升时可检测到SARS-CoV-2，PPA为97%。两个平台对SARS-CoV-2的阴性百分一致性均为100%。对一系列常见呼吸道靶点的分析特异性评估显示，各平台之间的性能相似。QIAstat-Dx RP2.0在临床样本中的总体PPA为82%（67-100%），敏感性因呼吸道靶点而异。两个平台均可用于检测SARS-CoV-2急性病例。虽然QIAstat-Dx RP2.0适用于在临床范围内检测呼吸道病毒，但与BioFire RP2.1相比，其对SARS-CoV-2的分析和临床敏感性较低。
