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Multicenter evaluation of the QIAstat-Dx respiratory panel for detection of viruses and bacteria in nasopharyngeal swab specimens

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Leber, Amy L ; Lisby, Jan Gorm ; Hansen, Glen ; Relich, Ryan F ; Schneider, Uffe Vest ; Granato, Paul ; Young, Stephen ; Pareja, Josep ; Hannet, Irene. / Multicenter evaluation of the QIAstat-Dx respiratory panel for detection of viruses and bacteria in nasopharyngeal swab specimens. I: Journal of Clinical Microbiology. 2020 ; Bind 58, Nr. 5. s. 1-11.

Bibtex

@article{89ab00c9f8cd4627904cac7a7102d238,
title = "Multicenter evaluation of the QIAstat-Dx respiratory panel for detection of viruses and bacteria in nasopharyngeal swab specimens",
abstract = "The QIAstat-Dx Respiratory Panel (QIAstat-Dx RP) is a multiplex in vitro diagnostic test for the qualitative detection of 20 pathogens directly from nasopharyngeal swab (NPS) specimens. The assay is performed using a simple sample-toanswer platform with results available in approximately 69 min. The pathogens identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A and B, influenza A, influenza A H1, influenza A H3, influenza A H1N1/2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, respiratory syncytial virus A and B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. This multicenter evaluation provides data obtained from 1,994 prospectively collected and 310 retrospectively collected (archived) NPS specimens with performance compared to that of the BioFire FilmArray Respiratory Panel, version 1.7. The overall percent agreement between QIAstat-Dx RP and the comparator testing was 99.5%. In the prospective cohort, the QIAstat-Dx RP demonstrated a positive percent agreement of 94.0% or greater for the detection of all but four analytes: coronaviruses 229E, NL63, and OC43 and rhinovirus/enterovirus. The test also demonstrated a negative percent agreement of ≥97.9% for all analytes. The QIAstat-Dx RP is a robust and accurate assay for rapid, comprehensive testing for respiratory pathogens.",
keywords = "Multiplex, PCR, Respiratory",
author = "Leber, {Amy L} and Lisby, {Jan Gorm} and Glen Hansen and Relich, {Ryan F} and Schneider, {Uffe Vest} and Paul Granato and Stephen Young and Josep Pareja and Irene Hannet",
note = "Copyright {\textcopyright} 2020 Leber et al.",
year = "2020",
month = apr,
day = "23",
doi = "10.1128/JCM.00155-20",
language = "English",
volume = "58",
pages = "1--11",
journal = "Journal of Clinical Microbiology",
issn = "0095-1137",
publisher = "American Society for Microbiology",
number = "5",

}

RIS

TY - JOUR

T1 - Multicenter evaluation of the QIAstat-Dx respiratory panel for detection of viruses and bacteria in nasopharyngeal swab specimens

AU - Leber, Amy L

AU - Lisby, Jan Gorm

AU - Hansen, Glen

AU - Relich, Ryan F

AU - Schneider, Uffe Vest

AU - Granato, Paul

AU - Young, Stephen

AU - Pareja, Josep

AU - Hannet, Irene

N1 - Copyright © 2020 Leber et al.

PY - 2020/4/23

Y1 - 2020/4/23

N2 - The QIAstat-Dx Respiratory Panel (QIAstat-Dx RP) is a multiplex in vitro diagnostic test for the qualitative detection of 20 pathogens directly from nasopharyngeal swab (NPS) specimens. The assay is performed using a simple sample-toanswer platform with results available in approximately 69 min. The pathogens identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A and B, influenza A, influenza A H1, influenza A H3, influenza A H1N1/2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, respiratory syncytial virus A and B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. This multicenter evaluation provides data obtained from 1,994 prospectively collected and 310 retrospectively collected (archived) NPS specimens with performance compared to that of the BioFire FilmArray Respiratory Panel, version 1.7. The overall percent agreement between QIAstat-Dx RP and the comparator testing was 99.5%. In the prospective cohort, the QIAstat-Dx RP demonstrated a positive percent agreement of 94.0% or greater for the detection of all but four analytes: coronaviruses 229E, NL63, and OC43 and rhinovirus/enterovirus. The test also demonstrated a negative percent agreement of ≥97.9% for all analytes. The QIAstat-Dx RP is a robust and accurate assay for rapid, comprehensive testing for respiratory pathogens.

AB - The QIAstat-Dx Respiratory Panel (QIAstat-Dx RP) is a multiplex in vitro diagnostic test for the qualitative detection of 20 pathogens directly from nasopharyngeal swab (NPS) specimens. The assay is performed using a simple sample-toanswer platform with results available in approximately 69 min. The pathogens identified are adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus A and B, influenza A, influenza A H1, influenza A H3, influenza A H1N1/2009, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, respiratory syncytial virus A and B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. This multicenter evaluation provides data obtained from 1,994 prospectively collected and 310 retrospectively collected (archived) NPS specimens with performance compared to that of the BioFire FilmArray Respiratory Panel, version 1.7. The overall percent agreement between QIAstat-Dx RP and the comparator testing was 99.5%. In the prospective cohort, the QIAstat-Dx RP demonstrated a positive percent agreement of 94.0% or greater for the detection of all but four analytes: coronaviruses 229E, NL63, and OC43 and rhinovirus/enterovirus. The test also demonstrated a negative percent agreement of ≥97.9% for all analytes. The QIAstat-Dx RP is a robust and accurate assay for rapid, comprehensive testing for respiratory pathogens.

KW - Multiplex

KW - PCR

KW - Respiratory

UR - http://www.scopus.com/inward/record.url?scp=85084027461&partnerID=8YFLogxK

U2 - 10.1128/JCM.00155-20

DO - 10.1128/JCM.00155-20

M3 - Journal article

C2 - 32132186

VL - 58

SP - 1

EP - 11

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

SN - 0095-1137

IS - 5

M1 - e00155-20

ER -

ID: 59510864