Author: Lebourgeois, Samuel; Storto, Alexandre; Gout, Bernard; Le Hingrat, Quentin; Tjader, Gustave Ardila; Cerdan, Maria del Carmen; English, Alistair; Pareja, Josep; Love, Joanna; Houhou-Fidouh, Nadhira; Manissero, Davide; Descamps, Diane; Visseaux, Benoit
Title: Performance Evaluation of the QIAstat-Dx® Respiratory SARS-CoV-2 Panel Cord-id: zzxvz0gp Document date: 2021_4_24
ID: zzxvz0gp
Snippet: OBJECTIVE: 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. METHODS: Nasopharyngeal swabs from patients with, or suspected of having, coronavirus disease 2019 were collected and tested at Bichat-Claude Bernard Hospital, Paris, Fra
Document: OBJECTIVE: 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. METHODS: 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 Heath 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. RESULTS: In total, 189 negative and 88 positive samples were analysed. QIAstat-SARS-CoV-2 had a 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). CONCLUSIONS: QIAstat-SARS-CoV-2 shows good agreement with the reference assay, providing faster and accurate results for the detection of SARS-CoV-2.
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