Lebourgeois Samuel, Storto Alexandre, Gout Bernard, Le Hingrat Quentin, Ardila Tjader Gustave, Cerdan Maria Del Carmen, English Alistair, Pareja Josep, Love Joanna, Houhou-Fidouh Nadhira, Manissero Davide, Descamps Diane, Visseaux Benoit
UMR 1137-IAME, Decision Sciences in Infectious Diseases Control and Care (DeSCID), INSERM, Université de Paris, Paris, France; Université de Paris, Assistance Publique - Hôpitaux de Paris, Service de Virologie, Hôpital Bichat, Paris, France.
ARC Regulatory Ltd., Moneymore, Magherafelt, Northern Ireland, UK.
Int J Infect Dis. 2021 Jun;107:179-181. doi: 10.1016/j.ijid.2021.04.066. Epub 2021 Apr 24.
The aim of this study was to evaluate the QIAstat-Dx® Respiratory SARS-CoV-2 Panel (QIAstat-SARS-CoV-2), which is a closed, fully automated, multiplex polymerase chain reaction (PCR) assay that detects severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and 21 other pathogens that cause respiratory disease.
Nasopharyngeal swabs from patients with or suspected of having coronavirus disease 2019 were collected and tested at Bichat-Claude Bernard Hospital, Paris, France. Using the World Health Organisation-approved real-time-PCR assay developed by the Charité Institute of Virology as the reference, positive percent agreement (PPA) and negative percent agreement (NPA) were calculated.
In total, 189 negative and 88 positive samples were analyzed. QIAstat-SARS-CoV-2 had an NPA of 90.48% (95% confidence interval (CI), 85.37%, 94.26%) and a PPA of 94.32% (95% CI, 87.24%, 98.13%). Co-infections were detected by QIAstat-SARS-CoV-2 in 4/277 specimens. The methods exhibited comparable failure rates (23/307 [7.5%] vs. 6/298 [2.0%] for QIAstat-SARS-CoV-2 and reference methods, respectively). The turnaround time was shorter for QIAstat-SARS-CoV-2 compared with the reference method (difference in mean -14:30 h [standard error, 0:03:23; 95% CI, -14:37, -14:24]; P < 0.001).
QIAstat-SARS-CoV-2 shows good agreement with the reference assay, providing faster and accurate results for detecting SARS-CoV-2.
本研究旨在评估QIAstat-Dx®呼吸道SARS-CoV-2检测试剂盒（QIAstat-SARS-CoV-2），这是一种封闭式全自动多重聚合酶链反应（PCR）检测方法，可检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）以及其他21种引起呼吸道疾病的病原体。
在法国巴黎的比沙-克劳德·贝尔纳医院收集了患有或疑似患有2019冠状病毒病患者的鼻咽拭子并进行检测。以世界卫生组织批准的、由夏里特病毒学研究所开发的实时PCR检测方法作为参考，计算阳性百分一致性（PPA）和阴性百分一致性（NPA）。
总共分析了189份阴性样本和88份阳性样本。QIAstat-SARS-CoV-2的NPA为90.48%（95%置信区间（CI），85.37%，94.26%），PPA为94.32%（95%CI，87.24%，98.13%）。QIAstat-SARS-CoV-2在4/277份标本中检测到合并感染。两种方法的失败率相当（QIAstat-SARS-CoV-2和参考方法分别为23/307[7.5%]和6/298[2.0%]）。与参考方法相比，QIAstat-SARS-CoV-2的周转时间更短（平均差异为-14:30小时[标准误差，0:03:23；95%CI，-14:37，-14:24]；P<0.001）。
QIAstat-SARS-CoV-2与参考检测方法显示出良好的一致性，在检测SARS-CoV-2时能提供更快、更准确的结果。
