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Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the First Rapid Multiplex PCR Commercial Assay for SARS-CoV-2 Detection.

Identifieur interne : 000F91 ( Main/Exploration ); précédent : 000F90; suivant : 000F92

Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the First Rapid Multiplex PCR Commercial Assay for SARS-CoV-2 Detection.

Auteurs : Benoit Visseaux [France] ; Quentin Le Hingrat [France] ; Gilles Collin [France] ; Donia Bouzid [France] ; Samuel Lebourgeois [France] ; Diane Le Pluart [France] ; Laurène Deconinck [France] ; François-Xavier Lescure [France] ; Jean-Christophe Lucet [France] ; Lila Bouadma [France] ; Jean-François Timsit [France] ; Diane Descamps [France] ; Yazdan Yazdanpanah [France] ; Enrique Casalino [France] ; Nadhira Houhou-Fidouh

Source :

RBID : pubmed:32341142

Descripteurs français

English descriptors

Abstract

In the race to contain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), efficient detection and triage of infected patients must rely on rapid and reliable testing. In this work, we performed the first evaluation of the QIAstat-Dx respiratory SARS-CoV-2 panel (QIAstat-SARS) for SARS-CoV-2 detection. This assay is the first rapid multiplex PCR (mPCR) assay, including SARS-CoV-2 detection, and is fully compatible with a non-PCR-trained laboratory or point-of-care (PoC) testing. This evaluation was performed using 69 primary clinical samples (66 nasopharyngeal swabs [NPS], 1 bronchoalveolar lavage fluid sample [BAL], 1 tracheal aspirate sample, and 1 bronchial aspirate sample) comparing SARS-CoV-2 detection with the currently WHO-recommended reverse transcription-PCR (RT-PCR) (WHO-RT-PCR) workflow. Additionally, a comparative limit of detection (LoD) assessment was performed for QIAstat-SARS and WHO-RT-PCR using a quantified clinical sample. Compatibility of sample pretreatment for viral neutralization or viscous samples with the QIAstat-SARS system were also tested. The QIAstat-Dx respiratory SARS-CoV-2 panel demonstrated a sensitivity comparable to that of the WHO-recommended assay with a limit of detection at 1,000 copies/ml. The overall percent agreement between QIAstat-Dx SARS and WHO-RT-PCR on 69 clinical samples was 97% with a sensitivity of 100% (40/40) and specificity at 93% (27/29). No cross-reaction was encountered for any other respiratory viruses or bacteria included in the panel. The QIAstat-SARS rapid multiplex PCR panel provides a highly sensitive, robust, and accurate assay for rapid detection of SARS-CoV-2. This assay allows rapid decisions even in non-PCR-trained laboratory or point-of-care testing, allowing innovative organization.

DOI: 10.1128/JCM.00630-20
PubMed: 32341142
PubMed Central: PMC7383528


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<name sortKey="Descamps, Diane" sort="Descamps, Diane" uniqKey="Descamps D" first="Diane" last="Descamps">Diane Descamps</name>
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<name sortKey="Yazdanpanah, Yazdan" sort="Yazdanpanah, Yazdan" uniqKey="Yazdanpanah Y" first="Yazdan" last="Yazdanpanah">Yazdan Yazdanpanah</name>
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<name sortKey="Houhou Fidouh, Nadhira" sort="Houhou Fidouh, Nadhira" uniqKey="Houhou Fidouh N" first="Nadhira" last="Houhou-Fidouh">Nadhira Houhou-Fidouh</name>
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<name sortKey="Yazdanpanah, Yazdan" sort="Yazdanpanah, Yazdan" uniqKey="Yazdanpanah Y" first="Yazdan" last="Yazdanpanah">Yazdan Yazdanpanah</name>
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<name sortKey="Houhou Fidouh, Nadhira" sort="Houhou Fidouh, Nadhira" uniqKey="Houhou Fidouh N" first="Nadhira" last="Houhou-Fidouh">Nadhira Houhou-Fidouh</name>
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<title level="j">Journal of clinical microbiology</title>
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<div type="abstract" xml:lang="en">In the race to contain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), efficient detection and triage of infected patients must rely on rapid and reliable testing. In this work, we performed the first evaluation of the QIAstat-Dx respiratory SARS-CoV-2 panel (QIAstat-SARS) for SARS-CoV-2 detection. This assay is the first rapid multiplex PCR (mPCR) assay, including SARS-CoV-2 detection, and is fully compatible with a non-PCR-trained laboratory or point-of-care (PoC) testing. This evaluation was performed using 69 primary clinical samples (66 nasopharyngeal swabs [NPS], 1 bronchoalveolar lavage fluid sample [BAL], 1 tracheal aspirate sample, and 1 bronchial aspirate sample) comparing SARS-CoV-2 detection with the currently WHO-recommended reverse transcription-PCR (RT-PCR) (WHO-RT-PCR) workflow. Additionally, a comparative limit of detection (LoD) assessment was performed for QIAstat-SARS and WHO-RT-PCR using a quantified clinical sample. Compatibility of sample pretreatment for viral neutralization or viscous samples with the QIAstat-SARS system were also tested. The QIAstat-Dx respiratory SARS-CoV-2 panel demonstrated a sensitivity comparable to that of the WHO-recommended assay with a limit of detection at 1,000 copies/ml. The overall percent agreement between QIAstat-Dx SARS and WHO-RT-PCR on 69 clinical samples was 97% with a sensitivity of 100% (40/40) and specificity at 93% (27/29). No cross-reaction was encountered for any other respiratory viruses or bacteria included in the panel. The QIAstat-SARS rapid multiplex PCR panel provides a highly sensitive, robust, and accurate assay for rapid detection of SARS-CoV-2. This assay allows rapid decisions even in non-PCR-trained laboratory or point-of-care testing, allowing innovative organization.</div>
</front>
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<DateCompleted>
<Year>2020</Year>
<Month>08</Month>
<Day>05</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>08</Month>
<Day>05</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1098-660X</ISSN>
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<Volume>58</Volume>
<Issue>8</Issue>
<PubDate>
<Year>2020</Year>
<Month>Jul</Month>
<Day>23</Day>
</PubDate>
</JournalIssue>
<Title>Journal of clinical microbiology</Title>
<ISOAbbreviation>J. Clin. Microbiol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the First Rapid Multiplex PCR Commercial Assay for SARS-CoV-2 Detection.</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1128/JCM.00630-20</ELocationID>
<Abstract>
<AbstractText>In the race to contain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), efficient detection and triage of infected patients must rely on rapid and reliable testing. In this work, we performed the first evaluation of the QIAstat-Dx respiratory SARS-CoV-2 panel (QIAstat-SARS) for SARS-CoV-2 detection. This assay is the first rapid multiplex PCR (mPCR) assay, including SARS-CoV-2 detection, and is fully compatible with a non-PCR-trained laboratory or point-of-care (PoC) testing. This evaluation was performed using 69 primary clinical samples (66 nasopharyngeal swabs [NPS], 1 bronchoalveolar lavage fluid sample [BAL], 1 tracheal aspirate sample, and 1 bronchial aspirate sample) comparing SARS-CoV-2 detection with the currently WHO-recommended reverse transcription-PCR (RT-PCR) (WHO-RT-PCR) workflow. Additionally, a comparative limit of detection (LoD) assessment was performed for QIAstat-SARS and WHO-RT-PCR using a quantified clinical sample. Compatibility of sample pretreatment for viral neutralization or viscous samples with the QIAstat-SARS system were also tested. The QIAstat-Dx respiratory SARS-CoV-2 panel demonstrated a sensitivity comparable to that of the WHO-recommended assay with a limit of detection at 1,000 copies/ml. The overall percent agreement between QIAstat-Dx SARS and WHO-RT-PCR on 69 clinical samples was 97% with a sensitivity of 100% (40/40) and specificity at 93% (27/29). No cross-reaction was encountered for any other respiratory viruses or bacteria included in the panel. The QIAstat-SARS rapid multiplex PCR panel provides a highly sensitive, robust, and accurate assay for rapid detection of SARS-CoV-2. This assay allows rapid decisions even in non-PCR-trained laboratory or point-of-care testing, allowing innovative organization.</AbstractText>
<CopyrightInformation>Copyright © 2020 Visseaux et al.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Visseaux</LastName>
<ForeName>Benoit</ForeName>
<Initials>B</Initials>
<Identifier Source="ORCID">https://orcid.org/0000-0002-9279-5538</Identifier>
<AffiliationInfo>
<Affiliation>Université de Paris, Assistance Publique - Hôpitaux de Paris, Service de Virologie, Hôpital Bichat, Paris, France benoit.visseaux@aphp.fr.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>UMR 1137-IAME, Decision Sciences in Infectious Diseases Control and Care (DeSCID), INSERM, Université de Paris, Paris, France.</Affiliation>
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<LastName>Le Hingrat</LastName>
<ForeName>Quentin</ForeName>
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<Identifier Source="ORCID">https://orcid.org/0000-0001-9017-4941</Identifier>
<AffiliationInfo>
<Affiliation>Université de Paris, Assistance Publique - Hôpitaux de Paris, Service de Virologie, Hôpital Bichat, Paris, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>UMR 1137-IAME, Decision Sciences in Infectious Diseases Control and Care (DeSCID), INSERM, Université de Paris, Paris, France.</Affiliation>
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<Affiliation>Université de Paris, Assistance Publique - Hôpitaux de Paris, Service de Virologie, Hôpital Bichat, Paris, France.</Affiliation>
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