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


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.

SUBMITTER: Lebourgeois S 

PROVIDER: S-EPMC8064816 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Lebourgeois Samuel S   Storto Alexandre A   Gout Bernard B   Le Hingrat Quentin Q   Ardila Tjader Gustave G   Cerdan Maria Del Carmen MDC   English Alistair A   Pareja Josep J   Love Joanna J   Houhou-Fidouh Nadhira N   Manissero Davide D   Descamps Diane D   Visseaux Benoit B  

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20210424


<h4>Objective</h4>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.<h4>Methods</h4>Nasopharyngeal swabs from patients with or suspected of having coronavirus disease 2019 were collected and tested at Bichat-Claude Bernard Hospital,  ...[more]

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