Performance evaluation of the QIAstat-Dx® Respiratory SARS-CoV-2 Panel
Autor: | Josep Pareja, Bernard Gout, Quentin Le Hingrat, Maria del Carmen Cerdan, Joanna Love, Davide Manissero, Gustave Ardila Tjader, Diane Descamps, Nadhira Houhou-Fidouh, Alexandre Storto, Benoit Visseaux, Samuel Lebourgeois, Alistair English |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Adult
Male 0301 basic medicine Microbiology (medical) medicine.medical_specialty Adolescent Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 030106 microbiology Infectious and parasitic diseases RC109-216 Gastroenterology Article Young Adult 03 medical and health sciences 0302 clinical medicine Nasopharynx Internal medicine Multiplex polymerase chain reaction medicine Humans Multiplex 030212 general & internal medicine Respiratory system Child ComputingMethodologies_COMPUTERGRAPHICS Aged Retrospective Studies Aged 80 and over Real time-PCR business.industry SARS-CoV-2 Respiratory disease Infant COVID-19 General Medicine Middle Aged medicine.disease Confidence interval Diagnostic testing Infectious Diseases Real-time polymerase chain reaction Standard error COVID-19 Nucleic Acid Testing Child Preschool Female business Multiplex Polymerase Chain Reaction |
Zdroj: | International Journal of Infectious Diseases, Vol 107, Iss, Pp 179-181 (2021) International Journal of Infectious Diseases |
ISSN: | 1201-9712 |
Popis: | Graphical 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 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 |
Databáze: | OpenAIRE |
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