Performance evaluation of the QIAstat-Dx® Respiratory SARS-CoV-2 Panel.

Performance evaluation of the QIAstat-Dx® Respiratory SARS-CoV-2 Panel.

Bernard Gout, Maria del Carmen Cerdan, Alistair English, Josep Pareja, Joanna Love, Davide Manissero, Samuel Lebourgeois, Alexandre Storto, Quentin Le Hingrat, Gustave Ardila Tjader, Nadhira Houhou-Fidouh, Diane Descamps, Benoit Visseaux

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.

2021

real-time PCR, Multiplex, covid-19, SARS-CoV-2, diagnostic testing

10.1016/j.ijid.2021.04.066

International Journal of Infectious Diseases

Elsevier