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Observational Study
. 2021 Jun:107:179-181.
doi: 10.1016/j.ijid.2021.04.066. Epub 2021 Apr 24.

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

Samuel Lebourgeois  1 , Alexandre Storto  1 , Bernard Gout  2 , Quentin Le Hingrat  1 , Gustave Ardila Tjader  3 , Maria Del Carmen Cerdan  4 , Alistair English  5 , Josep Pareja  4 , Joanna Love  4 , Nadhira Houhou-Fidouh  3 , Davide Manissero  5 , Diane Descamps  1 , Benoit Visseaux  6
Affiliations
Observational Study

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

Samuel Lebourgeois et al. Int J Infect Dis. 2021 Jun.

Abstract

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 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.

Results: 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).

Conclusions: QIAstat-SARS-CoV-2 shows good agreement with the reference assay, providing faster and accurate results for detecting SARS-CoV-2.

Keywords: COVID-19; Diagnostic testing; Multiplex; Real time-PCR; SARS-CoV-2.

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Figures

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Graphical abstract
Figure 1
Figure 1
Study flow diagram.
See this image and copyright information in PMC

References

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