CovidFranceV1, Main, Exploration, bibRecord, 000A91

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.

Identifieur interne : 000A91 ( Main/Exploration ); précédent : 000A90; suivant : 000A92

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.

Auteurs : Michael J. Loeffelholz [Oman] ; David Alland [États-Unis] ; Susan M. Butler-Wu [États-Unis] ; Utsav Pandey [États-Unis] ; Carlo Frederico Perno [Italie] ; Alice Nava [Italie] ; Karen C. Carroll [États-Unis] ; Heba Mostafa [États-Unis] ; Emma Davies [Royaume-Uni] ; Ashley Mcewan [Royaume-Uni] ; Jennifer L. Rakeman [États-Unis] ; Randal C. Fowler [États-Unis] ; Jean-Michel Pawlotsky [France] ; Slim Fourati [France] ; Sukalyani Banik [États-Unis] ; Padmapriya P. Banada [États-Unis] ; Shobha Swaminathan [États-Unis] ; Soumitesh Chakravorty [États-Unis] ; Robert W. Kwiatkowski [États-Unis] ; Victor C. Chu [États-Unis] ; Joann Kop [États-Unis] ; Rajiv Gaur [États-Unis] ; Mandy L Y. Sin [États-Unis] ; Duy Nguyen [États-Unis] ; Simranjit Singh [États-Unis] ; Na Zhang [États-Unis] ; David H. Persing [États-Unis]

Source :

Journal of clinical microbiology [ 1098-660X ] ; 2020.

RBID : pubmed:32366669

Descripteurs français

KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Betacoronavirus (génétique), Betacoronavirus (isolement et purification), Enfant (MeSH), Enfant d'âge préscolaire (MeSH), Femelle (MeSH), Humains (MeSH), Infections à coronavirus (diagnostic), Infections à coronavirus (virologie), Jeune adulte (MeSH), Laboratoire automatique (méthodes), Mâle (MeSH), Nourrisson (MeSH), Nouveau-né (MeSH), Pandémies (MeSH), Partie nasale du pharynx (virologie), Pneumopathie virale (diagnostic), Pneumopathie virale (virologie), Sensibilité et spécificité (MeSH), Sujet âgé (MeSH), Sujet âgé de 80 ans ou plus (MeSH), Techniques de diagnostic moléculaire (méthodes), Techniques de laboratoire clinique (méthodes).
MESH :
- diagnostic : Infections à coronavirus, Pneumopathie virale.
- génétique : Betacoronavirus.
- isolement et purification : Betacoronavirus.
- méthodes : Laboratoire automatique, Techniques de diagnostic moléculaire, Techniques de laboratoire clinique.
- virologie : Infections à coronavirus, Partie nasale du pharynx, Pneumopathie virale.
- Adolescent, Adulte, Adulte d'âge moyen, Enfant, Enfant d'âge préscolaire, Femelle, Humains, Jeune adulte, Mâle, Nourrisson, Nouveau-né, Pandémies, Sensibilité et spécificité, Sujet âgé, Sujet âgé de 80 ans ou plus.

English descriptors

KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Automation, Laboratory (methods), Betacoronavirus (genetics), Betacoronavirus (isolation & purification), Child (MeSH), Child, Preschool (MeSH), Clinical Laboratory Techniques (methods), Coronavirus Infections (diagnosis), Coronavirus Infections (virology), Female (MeSH), Humans (MeSH), Infant (MeSH), Infant, Newborn (MeSH), Male (MeSH), Middle Aged (MeSH), Molecular Diagnostic Techniques (methods), Nasopharynx (virology), Pandemics (MeSH), Pneumonia, Viral (diagnosis), Pneumonia, Viral (virology), Sensitivity and Specificity (MeSH), Young Adult (MeSH).
MESH :
- diagnosis : Coronavirus Infections, Pneumonia, Viral.
- genetics : Betacoronavirus.
- isolation & purification : Betacoronavirus.
- methods : Automation, Laboratory, Clinical Laboratory Techniques, Molecular Diagnostic Techniques.
- virology : Coronavirus Infections, Nasopharynx, Pneumonia, Viral.
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Pandemics, Sensitivity and Specificity, Young Adult.

Abstract

Nucleic acid amplification tests (NAATs) are the primary means of identifying acute infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Accurate and fast test results may permit more efficient use of protective and isolation resources and allow rapid therapeutic interventions. We evaluated the analytical and clinical performance characteristics of the Xpert Xpress SARS-CoV-2 (Xpert) test, a rapid, automated molecular test for SARS-CoV-2. Analytical sensitivity and specificity/interference were assessed with infectious SARS-CoV-2; other infectious coronavirus species, including SARS-CoV; and 85 nasopharyngeal swab specimens positive for other respiratory viruses, including endemic human coronaviruses (hCoVs). Clinical performance was assessed using 483 remnant upper- and lower-respiratory-tract specimens previously analyzed by standard-of-care (SOC) NAATs. The limit of detection of the Xpert test was 0.01 PFU/ml. Other hCoVs, including Middle East respiratory syndrome coronavirus, were not detected by the Xpert test. SARS-CoV, a closely related species in the subgenus Sarbecovirus, was detected by a broad-range target (E) but was distinguished from SARS-CoV-2 (SARS-CoV-2-specific N2 target). Compared to SOC NAATs, the positive agreement of the Xpert test was 219/220 (99.5%), and the negative agreement was 250/261 (95.8%). A third tie-breaker NAAT resolved all but three of the discordant results in favor the Xpert test. The Xpert test provided sensitive and accurate detection of SARS-CoV-2 in a variety of upper- and lower-respiratory-tract specimens. The high sensitivity and short time to results of approximately 45 min may impact patient management.

DOI: 10.1128/JCM.00926-20
PubMed: 32366669
PubMed Central: PMC7383535

Affiliations:

France, Italie, Oman, Royaume-Uni, États-Unis
Angleterre, Californie, Grand Manchester, Lombardie, Maryland, État de New York, Île-de-France
Créteil, Manchester, Milan

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

to stream Main, to step Corpus: 001457
to stream Main, to step Curation: 001457

Le document en format XML

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<author><name sortKey="Davies, Emma" sort="Davies, Emma" uniqKey="Davies E" first="Emma" last="Davies">Emma Davies</name>
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<author><name sortKey="Fourati, Slim" sort="Fourati, Slim" uniqKey="Fourati S" first="Slim" last="Fourati">Slim Fourati</name>
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<author><name sortKey="Banada, Padmapriya P" sort="Banada, Padmapriya P" uniqKey="Banada P" first="Padmapriya P" last="Banada">Padmapriya P. Banada</name>
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</affiliation>
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<author><name sortKey="Swaminathan, Shobha" sort="Swaminathan, Shobha" uniqKey="Swaminathan S" first="Shobha" last="Swaminathan">Shobha Swaminathan</name>
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<wicri:noRegion>Newark New Jersey</wicri:noRegion>
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<author><name sortKey="Chakravorty, Soumitesh" sort="Chakravorty, Soumitesh" uniqKey="Chakravorty S" first="Soumitesh" last="Chakravorty">Soumitesh Chakravorty</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
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<author><name sortKey="Kwiatkowski, Robert W" sort="Kwiatkowski, Robert W" uniqKey="Kwiatkowski R" first="Robert W" last="Kwiatkowski">Robert W. Kwiatkowski</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
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</placeName>
</affiliation>
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<author><name sortKey="Chu, Victor C" sort="Chu, Victor C" uniqKey="Chu V" first="Victor C" last="Chu">Victor C. Chu</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kop, Joann" sort="Kop, Joann" uniqKey="Kop J" first="Joann" last="Kop">Joann Kop</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gaur, Rajiv" sort="Gaur, Rajiv" uniqKey="Gaur R" first="Rajiv" last="Gaur">Rajiv Gaur</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sin, Mandy L Y" sort="Sin, Mandy L Y" uniqKey="Sin M" first="Mandy L Y" last="Sin">Mandy L Y. Sin</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nguyen, Duy" sort="Nguyen, Duy" uniqKey="Nguyen D" first="Duy" last="Nguyen">Duy Nguyen</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Singh, Simranjit" sort="Singh, Simranjit" uniqKey="Singh S" first="Simranjit" last="Singh">Simranjit Singh</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Zhang, Na" sort="Zhang, Na" uniqKey="Zhang N" first="Na" last="Zhang">Na Zhang</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Persing, David H" sort="Persing, David H" uniqKey="Persing D" first="David H" last="Persing">David H. Persing</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.</title>
<author><name sortKey="Loeffelholz, Michael J" sort="Loeffelholz, Michael J" uniqKey="Loeffelholz M" first="Michael J" last="Loeffelholz">Michael J. Loeffelholz</name>
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<author><name sortKey="Alland, David" sort="Alland, David" uniqKey="Alland D" first="David" last="Alland">David Alland</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey</wicri:regionArea>
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<author><name sortKey="Butler Wu, Susan M" sort="Butler Wu, Susan M" uniqKey="Butler Wu S" first="Susan M" last="Butler-Wu">Susan M. Butler-Wu</name>
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<wicri:regionArea>Keck School of Medicine of USC, Department of Pathology, Los Angeles, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
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<author><name sortKey="Pandey, Utsav" sort="Pandey, Utsav" uniqKey="Pandey U" first="Utsav" last="Pandey">Utsav Pandey</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Children's Hospital Los Angeles, Los Angeles, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
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<author><name sortKey="Perno, Carlo Frederico" sort="Perno, Carlo Frederico" uniqKey="Perno C" first="Carlo Frederico" last="Perno">Carlo Frederico Perno</name>
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<region nuts="2">Lombardie</region>
</placeName>
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<author><name sortKey="Nava, Alice" sort="Nava, Alice" uniqKey="Nava A" first="Alice" last="Nava">Alice Nava</name>
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<country xml:lang="fr">Italie</country>
<wicri:regionArea>Niguarda Hospital, Ospedale Niguarda Ca' Granda, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
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<author><name sortKey="Carroll, Karen C" sort="Carroll, Karen C" uniqKey="Carroll K" first="Karen C" last="Carroll">Karen C. Carroll</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The Johns Hopkins University School of Medicine, Baltimore, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
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<author><name sortKey="Mostafa, Heba" sort="Mostafa, Heba" uniqKey="Mostafa H" first="Heba" last="Mostafa">Heba Mostafa</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The Johns Hopkins University School of Medicine, Baltimore, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
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<author><name sortKey="Davies, Emma" sort="Davies, Emma" uniqKey="Davies E" first="Emma" last="Davies">Emma Davies</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Virology, Manchester University NHS Foundation Trust, Manchester</wicri:regionArea>
<placeName><settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Manchester</region>
</placeName>
</affiliation>
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<author><name sortKey="Mcewan, Ashley" sort="Mcewan, Ashley" uniqKey="Mcewan A" first="Ashley" last="Mcewan">Ashley Mcewan</name>
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<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Virology, Manchester University NHS Foundation Trust, Manchester</wicri:regionArea>
<placeName><settlement type="city">Manchester</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Manchester</region>
</placeName>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
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<author><name sortKey="Fowler, Randal C" sort="Fowler, Randal C" uniqKey="Fowler R" first="Randal C" last="Fowler">Randal C. Fowler</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York</wicri:regionArea>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Bacteriology-Virology, Henri Mondor Hospital, Creteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
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<settlement type="city">Créteil</settlement>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Bacteriology-Virology, Henri Mondor Hospital, Creteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey</wicri:regionArea>
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<author><name sortKey="Banada, Padmapriya P" sort="Banada, Padmapriya P" uniqKey="Banada P" first="Padmapriya P" last="Banada">Padmapriya P. Banada</name>
<affiliation wicri:level="1"><nlm:affiliation>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey</wicri:regionArea>
<wicri:noRegion>Newark New Jersey</wicri:noRegion>
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<author><name sortKey="Swaminathan, Shobha" sort="Swaminathan, Shobha" uniqKey="Swaminathan S" first="Shobha" last="Swaminathan">Shobha Swaminathan</name>
<affiliation wicri:level="1"><nlm:affiliation>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey</wicri:regionArea>
<wicri:noRegion>Newark New Jersey</wicri:noRegion>
</affiliation>
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<author><name sortKey="Chakravorty, Soumitesh" sort="Chakravorty, Soumitesh" uniqKey="Chakravorty S" first="Soumitesh" last="Chakravorty">Soumitesh Chakravorty</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kwiatkowski, Robert W" sort="Kwiatkowski, Robert W" uniqKey="Kwiatkowski R" first="Robert W" last="Kwiatkowski">Robert W. Kwiatkowski</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chu, Victor C" sort="Chu, Victor C" uniqKey="Chu V" first="Victor C" last="Chu">Victor C. Chu</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kop, Joann" sort="Kop, Joann" uniqKey="Kop J" first="Joann" last="Kop">Joann Kop</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gaur, Rajiv" sort="Gaur, Rajiv" uniqKey="Gaur R" first="Rajiv" last="Gaur">Rajiv Gaur</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sin, Mandy L Y" sort="Sin, Mandy L Y" uniqKey="Sin M" first="Mandy L Y" last="Sin">Mandy L Y. Sin</name>
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<country xml:lang="fr">États-Unis</country>
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<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nguyen, Duy" sort="Nguyen, Duy" uniqKey="Nguyen D" first="Duy" last="Nguyen">Duy Nguyen</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Singh, Simranjit" sort="Singh, Simranjit" uniqKey="Singh S" first="Simranjit" last="Singh">Simranjit Singh</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Zhang, Na" sort="Zhang, Na" uniqKey="Zhang N" first="Na" last="Zhang">Na Zhang</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Persing, David H" sort="Persing, David H" uniqKey="Persing D" first="David H" last="Persing">David H. Persing</name>
<affiliation wicri:level="2"><nlm:affiliation>Cepheid, Sunnyvale, California, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cepheid, Sunnyvale, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
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<series><title level="j">Journal of clinical microbiology</title>
<idno type="eISSN">1098-660X</idno>
<imprint><date when="2020" type="published">2020</date>
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<term>Betacoronavirus (isolation & purification)</term>
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<term>Coronavirus Infections (virology)</term>
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<front><div type="abstract" xml:lang="en">Nucleic acid amplification tests (NAATs) are the primary means of identifying acute infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Accurate and fast test results may permit more efficient use of protective and isolation resources and allow rapid therapeutic interventions. We evaluated the analytical and clinical performance characteristics of the Xpert Xpress SARS-CoV-2 (Xpert) test, a rapid, automated molecular test for SARS-CoV-2. Analytical sensitivity and specificity/interference were assessed with infectious SARS-CoV-2; other infectious coronavirus species, including SARS-CoV; and 85 nasopharyngeal swab specimens positive for other respiratory viruses, including endemic human coronaviruses (hCoVs). Clinical performance was assessed using 483 remnant upper- and lower-respiratory-tract specimens previously analyzed by standard-of-care (SOC) NAATs. The limit of detection of the Xpert test was 0.01 PFU/ml. Other hCoVs, including Middle East respiratory syndrome coronavirus, were not detected by the Xpert test. SARS-CoV, a closely related species in the subgenus <i>Sarbecovirus</i>
, was detected by a broad-range target (E) but was distinguished from SARS-CoV-2 (SARS-CoV-2-specific N2 target). Compared to SOC NAATs, the positive agreement of the Xpert test was 219/220 (99.5%), and the negative agreement was 250/261 (95.8%). A third tie-breaker NAAT resolved all but three of the discordant results in favor the Xpert test. The Xpert test provided sensitive and accurate detection of SARS-CoV-2 in a variety of upper- and lower-respiratory-tract specimens. The high sensitivity and short time to results of approximately 45 min may impact patient management.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32366669</PMID>
<DateCompleted><Year>2020</Year>
<Month>08</Month>
<Day>05</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>08</Month>
<Day>05</Day>
</DateRevised>
<Article PubModel="Electronic-Print"><Journal><ISSN IssnType="Electronic">1098-660X</ISSN>
<JournalIssue CitedMedium="Internet"><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>Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">e00926-20</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1128/JCM.00926-20</ELocationID>
<Abstract><AbstractText>Nucleic acid amplification tests (NAATs) are the primary means of identifying acute infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Accurate and fast test results may permit more efficient use of protective and isolation resources and allow rapid therapeutic interventions. We evaluated the analytical and clinical performance characteristics of the Xpert Xpress SARS-CoV-2 (Xpert) test, a rapid, automated molecular test for SARS-CoV-2. Analytical sensitivity and specificity/interference were assessed with infectious SARS-CoV-2; other infectious coronavirus species, including SARS-CoV; and 85 nasopharyngeal swab specimens positive for other respiratory viruses, including endemic human coronaviruses (hCoVs). Clinical performance was assessed using 483 remnant upper- and lower-respiratory-tract specimens previously analyzed by standard-of-care (SOC) NAATs. The limit of detection of the Xpert test was 0.01 PFU/ml. Other hCoVs, including Middle East respiratory syndrome coronavirus, were not detected by the Xpert test. SARS-CoV, a closely related species in the subgenus <i>Sarbecovirus</i>
, was detected by a broad-range target (E) but was distinguished from SARS-CoV-2 (SARS-CoV-2-specific N2 target). Compared to SOC NAATs, the positive agreement of the Xpert test was 219/220 (99.5%), and the negative agreement was 250/261 (95.8%). A third tie-breaker NAAT resolved all but three of the discordant results in favor the Xpert test. The Xpert test provided sensitive and accurate detection of SARS-CoV-2 in a variety of upper- and lower-respiratory-tract specimens. The high sensitivity and short time to results of approximately 45 min may impact patient management.</AbstractText>
<CopyrightInformation>Copyright © 2020 American Society for Microbiology.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Loeffelholz</LastName>
<ForeName>Michael J</ForeName>
<Initials>MJ</Initials>
<AffiliationInfo><Affiliation>Cepheid, Sunnyvale, California, USA Michael.loeffelholz@cepheid.com.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Alland</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Butler-Wu</LastName>
<ForeName>Susan M</ForeName>
<Initials>SM</Initials>
<AffiliationInfo><Affiliation>Keck School of Medicine of USC, Department of Pathology, Los Angeles, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pandey</LastName>
<ForeName>Utsav</ForeName>
<Initials>U</Initials>
<AffiliationInfo><Affiliation>Children's Hospital Los Angeles, Los Angeles, California, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Perno</LastName>
<ForeName>Carlo Frederico</ForeName>
<Initials>CF</Initials>
<AffiliationInfo><Affiliation>Niguarda Hospital, Ospedale Niguarda Ca' Granda, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Nava</LastName>
<ForeName>Alice</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Niguarda Hospital, Ospedale Niguarda Ca' Granda, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Carroll</LastName>
<ForeName>Karen C</ForeName>
<Initials>KC</Initials>
<AffiliationInfo><Affiliation>The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mostafa</LastName>
<ForeName>Heba</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Davies</LastName>
<ForeName>Emma</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McEwan</LastName>
<ForeName>Ashley</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rakeman</LastName>
<ForeName>Jennifer L</ForeName>
<Initials>JL</Initials>
<AffiliationInfo><Affiliation>NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fowler</LastName>
<ForeName>Randal C</ForeName>
<Initials>RC</Initials>
<AffiliationInfo><Affiliation>NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pawlotsky</LastName>
<ForeName>Jean-Michel</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Bacteriology-Virology, Henri Mondor Hospital, Creteil, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fourati</LastName>
<ForeName>Slim</ForeName>
<Initials>S</Initials>
<Identifier Source="ORCID">https://orcid.org/0000-0002-1236-5467</Identifier>
<AffiliationInfo><Affiliation>Bacteriology-Virology, Henri Mondor Hospital, Creteil, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Banik</LastName>
<ForeName>Sukalyani</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.</Affiliation>
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<Reference><Citation>Lancet Infect Dis. 2020 Apr;20(4):411-412</Citation>
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<Reference><Citation>J Clin Microbiol. 2020 Jul 23;58(8):</Citation>
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<Reference><Citation>Clin Infect Dis. 2020 Mar 28;:</Citation>
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<Reference><Citation>Lancet Infect Dis. 2020 May;20(5):565-574</Citation>
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<Reference><Citation>J Infect. 2020 Aug;81(2):318-356</Citation>
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Pour manipuler ce document sous Unix (Dilib)

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{{Explor lien
   |wiki=    Sante
   |area=    CovidFranceV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     pubmed:32366669
   |texte=   Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.
}}

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This area was generated with Dilib version V0.6.37.
Data generation: Tue Oct 6 23:31:36 2020. Site generation: Fri Feb 12 22:48:37 2021

	Serveur d'exploration sur la COVID en France
	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.

Serveur d'exploration sur la COVID en France

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.

Source :

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Abstract

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