Serveur d'exploration sur le Covid à Stanford

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.

Identifieur interne : 000679 ( Main/Exploration ); précédent : 000678; suivant : 000680

Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.

Auteurs : Bryan Stevens [États-Unis] ; Catherine A. Hogan [États-Unis] ; Malaya K. Sahoo [États-Unis] ; Chunhong Huang [États-Unis] ; Natasha Garamani [États-Unis] ; James Zehnder [États-Unis] ; Jason Kurzer ; Benjamin A. Pinsky [États-Unis]

Source :

RBID : pubmed:32761092

Descripteurs français

English descriptors

Abstract

BACKGROUND

Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays.

METHODS

A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.

RESULTS

A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8-100], positive percent agreement of 98.1% (95% CI: 90.1-100), and a negative percent agreement of 100% (95% CI: 94.2-100). The kappa coefficient was 0.98 (95% CI: 0.94-1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay.

CONCLUSIONS

The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity.


DOI: 10.1093/jalm/jfaa135
PubMed: 32761092
PubMed Central: PMC7454585


Affiliations:


Links toward previous steps (curation, corpus...)


Le document en format XML

<record>
<TEI>
<teiHeader>
<fileDesc>
<titleStmt>
<title xml:lang="en">Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.</title>
<author>
<name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Clinical Virology Laboratory, Stanford Health Care, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Hogan, Catherine A" sort="Hogan, Catherine A" uniqKey="Hogan C" first="Catherine A" last="Hogan">Catherine A. Hogan</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Clinical Virology Laboratory, Stanford Health Care, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Sahoo, Malaya K" sort="Sahoo, Malaya K" uniqKey="Sahoo M" first="Malaya K" last="Sahoo">Malaya K. Sahoo</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Huang, Chunhong" sort="Huang, Chunhong" uniqKey="Huang C" first="Chunhong" last="Huang">Chunhong Huang</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Garamani, Natasha" sort="Garamani, Natasha" uniqKey="Garamani N" first="Natasha" last="Garamani">Natasha Garamani</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Zehnder, James" sort="Zehnder, James" uniqKey="Zehnder J" first="James" last="Zehnder">James Zehnder</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Kurzer, Jason" sort="Kurzer, Jason" uniqKey="Kurzer J" first="Jason" last="Kurzer">Jason Kurzer</name>
<affiliation>
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<wicri:noCountry code="subField"> CA</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Clinical Virology Laboratory, Stanford Health Care, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">PubMed</idno>
<date when="2020">2020</date>
<idno type="RBID">pubmed:32761092</idno>
<idno type="pmid">32761092</idno>
<idno type="doi">10.1093/jalm/jfaa135</idno>
<idno type="pmc">PMC7454585</idno>
<idno type="wicri:Area/Main/Corpus">000449</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000449</idno>
<idno type="wicri:Area/Main/Curation">000449</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000449</idno>
<idno type="wicri:Area/Main/Exploration">000449</idno>
</publicationStmt>
<sourceDesc>
<biblStruct>
<analytic>
<title xml:lang="en">Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.</title>
<author>
<name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Clinical Virology Laboratory, Stanford Health Care, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Hogan, Catherine A" sort="Hogan, Catherine A" uniqKey="Hogan C" first="Catherine A" last="Hogan">Catherine A. Hogan</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Clinical Virology Laboratory, Stanford Health Care, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Sahoo, Malaya K" sort="Sahoo, Malaya K" uniqKey="Sahoo M" first="Malaya K" last="Sahoo">Malaya K. Sahoo</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Huang, Chunhong" sort="Huang, Chunhong" uniqKey="Huang C" first="Chunhong" last="Huang">Chunhong Huang</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Garamani, Natasha" sort="Garamani, Natasha" uniqKey="Garamani N" first="Natasha" last="Garamani">Natasha Garamani</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Zehnder, James" sort="Zehnder, James" uniqKey="Zehnder J" first="James" last="Zehnder">James Zehnder</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
<author>
<name sortKey="Kurzer, Jason" sort="Kurzer, Jason" uniqKey="Kurzer J" first="Jason" last="Kurzer">Jason Kurzer</name>
<affiliation>
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<wicri:noCountry code="subField"> CA</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name>
<affiliation wicri:level="2">
<nlm:affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Department of Pathology, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Clinical Virology Laboratory, Stanford Health Care, Stanford</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2">
<nlm:affiliation>Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName>
<region type="state">Californie</region>
</placeName>
<wicri:cityArea>Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">The journal of applied laboratory medicine</title>
<idno type="ISSN">2576-9456</idno>
<imprint>
<date when="2020" type="published">2020</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Automation, Laboratory (instrumentation)</term>
<term>Betacoronavirus (genetics)</term>
<term>Betacoronavirus (isolation & purification)</term>
<term>COVID-19 (MeSH)</term>
<term>COVID-19 Testing (MeSH)</term>
<term>Clinical Laboratory Techniques (instrumentation)</term>
<term>Clinical Laboratory Techniques (statistics & numerical data)</term>
<term>Coronavirus Infections (diagnosis)</term>
<term>Coronavirus Infections (epidemiology)</term>
<term>Coronavirus Infections (virology)</term>
<term>Humans (MeSH)</term>
<term>Molecular Diagnostic Techniques (instrumentation)</term>
<term>Molecular Diagnostic Techniques (statistics & numerical data)</term>
<term>Multiplex Polymerase Chain Reaction (instrumentation)</term>
<term>Pandemics (MeSH)</term>
<term>Pneumonia, Viral (diagnosis)</term>
<term>Pneumonia, Viral (epidemiology)</term>
<term>Pneumonia, Viral (virology)</term>
<term>Point-of-Care Systems (statistics & numerical data)</term>
<term>RNA, Viral (isolation & purification)</term>
<term>Reagent Kits, Diagnostic (statistics & numerical data)</term>
<term>Real-Time Polymerase Chain Reaction (instrumentation)</term>
<term>Reproducibility of Results (MeSH)</term>
<term>SARS-CoV-2 (MeSH)</term>
<term>Time Factors (MeSH)</term>
<term>United States (epidemiology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>ARN viral (isolement et purification)</term>
<term>Betacoronavirus (génétique)</term>
<term>Betacoronavirus (isolement et purification)</term>
<term>Facteurs temps (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Infections à coronavirus (diagnostic)</term>
<term>Infections à coronavirus (virologie)</term>
<term>Infections à coronavirus (épidémiologie)</term>
<term>Laboratoire automatique (instrumentation)</term>
<term>Pandémies (MeSH)</term>
<term>Pneumopathie virale (diagnostic)</term>
<term>Pneumopathie virale (virologie)</term>
<term>Pneumopathie virale (épidémiologie)</term>
<term>Reproductibilité des résultats (MeSH)</term>
<term>Réaction de polymérisation en chaine en temps réel (instrumentation)</term>
<term>Réaction de polymérisation en chaine multiplex (instrumentation)</term>
<term>Systèmes automatisés lit malade (statistiques et données numériques)</term>
<term>Techniques de diagnostic moléculaire (instrumentation)</term>
<term>Techniques de diagnostic moléculaire (statistiques et données numériques)</term>
<term>Techniques de laboratoire clinique (instrumentation)</term>
<term>Techniques de laboratoire clinique (statistiques et données numériques)</term>
<term>Trousses de réactifs pour diagnostic (statistiques et données numériques)</term>
<term>États-Unis (épidémiologie)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="isolation & purification" xml:lang="en">
<term>RNA, Viral</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en">
<term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="genetics" xml:lang="en">
<term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="génétique" xml:lang="fr">
<term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="instrumentation" xml:lang="en">
<term>Automation, Laboratory</term>
<term>Clinical Laboratory Techniques</term>
<term>Molecular Diagnostic Techniques</term>
<term>Multiplex Polymerase Chain Reaction</term>
<term>Real-Time Polymerase Chain Reaction</term>
</keywords>
<keywords scheme="MESH" qualifier="isolation & purification" xml:lang="en">
<term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr">
<term>ARN viral</term>
<term>Betacoronavirus</term>
<term>Laboratoire automatique</term>
<term>Réaction de polymérisation en chaine en temps réel</term>
<term>Réaction de polymérisation en chaine multiplex</term>
<term>Techniques de diagnostic moléculaire</term>
<term>Techniques de laboratoire clinique</term>
</keywords>
<keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en">
<term>Clinical Laboratory Techniques</term>
<term>Molecular Diagnostic Techniques</term>
<term>Point-of-Care Systems</term>
<term>Reagent Kits, Diagnostic</term>
</keywords>
<keywords scheme="MESH" qualifier="statistiques et données numériques" xml:lang="fr">
<term>Systèmes automatisés lit malade</term>
<term>Techniques de diagnostic moléculaire</term>
<term>Techniques de laboratoire clinique</term>
<term>Trousses de réactifs pour diagnostic</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
<term>États-Unis</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>COVID-19</term>
<term>COVID-19 Testing</term>
<term>Humans</term>
<term>Pandemics</term>
<term>Reproducibility of Results</term>
<term>SARS-CoV-2</term>
<term>Time Factors</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Facteurs temps</term>
<term>Humains</term>
<term>Pandémies</term>
<term>Reproductibilité des résultats</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr">
<term>États-Unis</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8-100], positive percent agreement of 98.1% (95% CI: 90.1-100), and a negative percent agreement of 100% (95% CI: 94.2-100). The kappa coefficient was 0.98 (95% CI: 0.94-1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity.</p>
</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">32761092</PMID>
<DateCompleted>
<Year>2020</Year>
<Month>12</Month>
<Day>01</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>12</Month>
<Day>18</Day>
</DateRevised>
<Article PubModel="Print">
<Journal>
<ISSN IssnType="Print">2576-9456</ISSN>
<JournalIssue CitedMedium="Print">
<Volume>5</Volume>
<Issue>6</Issue>
<PubDate>
<Year>2020</Year>
<Month>11</Month>
<Day>01</Day>
</PubDate>
</JournalIssue>
<Title>The journal of applied laboratory medicine</Title>
<ISOAbbreviation>J Appl Lab Med</ISOAbbreviation>
</Journal>
<ArticleTitle>Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.</ArticleTitle>
<Pagination>
<MedlinePgn>1307-1312</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/jalm/jfaa135</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND">Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays.</AbstractText>
<AbstractText Label="METHODS">A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.</AbstractText>
<AbstractText Label="RESULTS">A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8-100], positive percent agreement of 98.1% (95% CI: 90.1-100), and a negative percent agreement of 100% (95% CI: 94.2-100). The kappa coefficient was 0.98 (95% CI: 0.94-1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay.</AbstractText>
<AbstractText Label="CONCLUSIONS">The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity.</AbstractText>
<CopyrightInformation>© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Stevens</LastName>
<ForeName>Bryan</ForeName>
<Initials>B</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Hogan</LastName>
<ForeName>Catherine A</ForeName>
<Initials>CA</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Sahoo</LastName>
<ForeName>Malaya K</ForeName>
<Initials>MK</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Huang</LastName>
<ForeName>ChunHong</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Garamani</LastName>
<ForeName>Natasha</ForeName>
<Initials>N</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Zehnder</LastName>
<ForeName>James</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kurzer</LastName>
<ForeName>Jason</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pinsky</LastName>
<ForeName>Benjamin A</ForeName>
<Initials>BA</Initials>
<AffiliationInfo>
<Affiliation>Department of Pathology, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D003160">Comparative Study</PublicationType>
<PublicationType UI="D023362">Evaluation Study</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>J Appl Lab Med</MedlineTA>
<NlmUniqueID>101693884</NlmUniqueID>
<ISSNLinking>2475-7241</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D012367">RNA, Viral</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D011933">Reagent Kits, Diagnostic</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D057205" MajorTopicYN="N">Automation, Laboratory</DescriptorName>
<QualifierName UI="Q000295" MajorTopicYN="N">instrumentation</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
<QualifierName UI="Q000302" MajorTopicYN="Y">isolation & purification</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000086742" MajorTopicYN="N">COVID-19 Testing</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019411" MajorTopicYN="N">Clinical Laboratory Techniques</DescriptorName>
<QualifierName UI="Q000295" MajorTopicYN="Y">instrumentation</QualifierName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D025202" MajorTopicYN="N">Molecular Diagnostic Techniques</DescriptorName>
<QualifierName UI="Q000295" MajorTopicYN="Y">instrumentation</QualifierName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D060885" MajorTopicYN="N">Multiplex Polymerase Chain Reaction</DescriptorName>
<QualifierName UI="Q000295" MajorTopicYN="N">instrumentation</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="Y">diagnosis</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019095" MajorTopicYN="N">Point-of-Care Systems</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D012367" MajorTopicYN="N">RNA, Viral</DescriptorName>
<QualifierName UI="Q000302" MajorTopicYN="Y">isolation & purification</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011933" MajorTopicYN="N">Reagent Kits, Diagnostic</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D060888" MajorTopicYN="N">Real-Time Polymerase Chain Reaction</DescriptorName>
<QualifierName UI="Q000295" MajorTopicYN="N">instrumentation</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="Y">COVID-19</Keyword>
<Keyword MajorTopicYN="Y">Cepheid GeneXpert</Keyword>
<Keyword MajorTopicYN="Y">Panther Fusion</Keyword>
<Keyword MajorTopicYN="Y">SARS-CoV-2</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2020</Year>
<Month>06</Month>
<Day>08</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2020</Year>
<Month>07</Month>
<Day>15</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed">
<Year>2020</Year>
<Month>8</Month>
<Day>8</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2020</Year>
<Month>12</Month>
<Day>2</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2020</Year>
<Month>8</Month>
<Day>8</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">32761092</ArticleId>
<ArticleId IdType="pii">5881637</ArticleId>
<ArticleId IdType="doi">10.1093/jalm/jfaa135</ArticleId>
<ArticleId IdType="pmc">PMC7454585</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations>
<list>
<country>
<li>États-Unis</li>
</country>
<region>
<li>Californie</li>
</region>
</list>
<tree>
<noCountry>
<name sortKey="Kurzer, Jason" sort="Kurzer, Jason" uniqKey="Kurzer J" first="Jason" last="Kurzer">Jason Kurzer</name>
</noCountry>
<country name="États-Unis">
<region name="Californie">
<name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name>
</region>
<name sortKey="Garamani, Natasha" sort="Garamani, Natasha" uniqKey="Garamani N" first="Natasha" last="Garamani">Natasha Garamani</name>
<name sortKey="Hogan, Catherine A" sort="Hogan, Catherine A" uniqKey="Hogan C" first="Catherine A" last="Hogan">Catherine A. Hogan</name>
<name sortKey="Hogan, Catherine A" sort="Hogan, Catherine A" uniqKey="Hogan C" first="Catherine A" last="Hogan">Catherine A. Hogan</name>
<name sortKey="Huang, Chunhong" sort="Huang, Chunhong" uniqKey="Huang C" first="Chunhong" last="Huang">Chunhong Huang</name>
<name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name>
<name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name>
<name sortKey="Pinsky, Benjamin A" sort="Pinsky, Benjamin A" uniqKey="Pinsky B" first="Benjamin A" last="Pinsky">Benjamin A. Pinsky</name>
<name sortKey="Sahoo, Malaya K" sort="Sahoo, Malaya K" uniqKey="Sahoo M" first="Malaya K" last="Sahoo">Malaya K. Sahoo</name>
<name sortKey="Stevens, Bryan" sort="Stevens, Bryan" uniqKey="Stevens B" first="Bryan" last="Stevens">Bryan Stevens</name>
<name sortKey="Zehnder, James" sort="Zehnder, James" uniqKey="Zehnder J" first="James" last="Zehnder">James Zehnder</name>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/CovidStanfordV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000679 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000679 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    CovidStanfordV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     pubmed:32761092
   |texte=   Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:32761092" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a CovidStanfordV1 

Wicri

This area was generated with Dilib version V0.6.38.
Data generation: Tue Feb 2 21:24:25 2021. Site generation: Tue Feb 2 21:26:08 2021