tetano
Editor, Senior Moderator
Int J Infect Dis
. 2021 Apr 23;S1201-9712(21)00378-7.
doi: 10.1016/j.ijid.2021.04.066. Online ahead of print.
Performance Evaluation of the QIAstat-Dx? Respiratory SARS-CoV-2 Panel
Samuel Lebourgeois[SUP] 1 [/SUP], Alexandre Storto[SUP] 1 [/SUP], Bernard Gout[SUP] 2 [/SUP], Quentin Le Hingrat[SUP] 1 [/SUP], Gustave Ardila Tjader[SUP] 3 [/SUP], Maria Del Carmen Cerdan[SUP] 4 [/SUP], Alistair English[SUP] 5 [/SUP], Josep Pareja[SUP] 4 [/SUP], Joanna Love[SUP] 4 [/SUP], Nadhira Houhou-Fidouh[SUP] 3 [/SUP], Davide Manissero[SUP] 5 [/SUP], Diane Descamps[SUP] 1 [/SUP], Benoit Visseaux[SUP] 6 [/SUP]
Affiliations
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 Heath Organisation-approved real-time-PCR assay developed by the Charit? 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.
Keywords: COVID-19; Diagnostic testing; Multiplex; Real time-PCR; SARS-CoV-2.
. 2021 Apr 23;S1201-9712(21)00378-7.
doi: 10.1016/j.ijid.2021.04.066. Online ahead of print.
Performance Evaluation of the QIAstat-Dx? Respiratory SARS-CoV-2 Panel
Samuel Lebourgeois[SUP] 1 [/SUP], Alexandre Storto[SUP] 1 [/SUP], Bernard Gout[SUP] 2 [/SUP], Quentin Le Hingrat[SUP] 1 [/SUP], Gustave Ardila Tjader[SUP] 3 [/SUP], Maria Del Carmen Cerdan[SUP] 4 [/SUP], Alistair English[SUP] 5 [/SUP], Josep Pareja[SUP] 4 [/SUP], Joanna Love[SUP] 4 [/SUP], Nadhira Houhou-Fidouh[SUP] 3 [/SUP], Davide Manissero[SUP] 5 [/SUP], Diane Descamps[SUP] 1 [/SUP], Benoit Visseaux[SUP] 6 [/SUP]
Affiliations
- PMID: 33901651
- DOI: 10.1016/j.ijid.2021.04.066
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 Heath Organisation-approved real-time-PCR assay developed by the Charit? 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.
Keywords: COVID-19; Diagnostic testing; Multiplex; Real time-PCR; SARS-CoV-2.