Performance evaluation of the QIAstat-Dx® Respiratory SARS-CoV-2 Panel.
Int J Infect Dis
; 107: 179-181, 2021 Jun.
Artículo
en Inglés
| MEDLINE | ID: covidwho-1300799
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 -1430 h [standard error, 00323; 95% CI, -1437, -1424]; 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.Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Reacción en Cadena de la Polimerasa Multiplex
/
Prueba de Ácido Nucleico para COVID-19
/
SARS-CoV-2
/
COVID-19
Tipo de estudio:
Estudios diagnósticos
/
Estudio experimental
/
Estudio observacional
Límite:
Adolescente
/
Adulto
/
Anciano
/
Niño
/
Child, preschool
/
Femenino
/
Humanos
/
Lactante
/
Masculino
/
Middle aged
Idioma:
Inglés
Revista:
Int J Infect Dis
Asunto de la revista:
Enfermedades Transmisibles
Año:
2021
Tipo del documento:
Artículo
País de afiliación:
J.ijid.2021.04.066
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