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Special Issue Virology

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

Michael J. Loeffelholz, David Alland, Susan M. Butler-Wu, Utsav Pandey, Carlo Frederico Perno, Alice Nava, Karen C. Carroll, Heba Mostafa, Emma Davies, Ashley McEwan, Jennifer L. Rakeman, Randal C. Fowler, Jean-Michel Pawlotsky, Slim Fourati, Sukalyani Banik, Padmapriya P. Banada, Shobha Swaminathan, Soumitesh Chakravorty, Robert W. Kwiatkowski, Victor C. Chu, JoAnn Kop, Rajiv Gaur, Mandy L. Y. Sin, Duy Nguyen, Simranjit Singh, Na Zhang, David H. Persing
Alexander J. McAdam, Editor
Michael J. Loeffelholz
aCepheid, Sunnyvale, California, USA
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David Alland
bCenter for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA
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Susan M. Butler-Wu
cKeck School of Medicine of USC, Department of Pathology, Los Angeles, California, USA
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Utsav Pandey
dChildren’s Hospital Los Angeles, Los Angeles, California, USA
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Carlo Frederico Perno
eNiguarda Hospital, Ospedale Niguarda Ca’ Granda, Milan, Italy
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Alice Nava
eNiguarda Hospital, Ospedale Niguarda Ca’ Granda, Milan, Italy
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Karen C. Carroll
fThe Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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Heba Mostafa
fThe Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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Emma Davies
gDepartment of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom
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Ashley McEwan
gDepartment of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom
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Jennifer L. Rakeman
hNYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA
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Randal C. Fowler
hNYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA
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Jean-Michel Pawlotsky
iBacteriology-Virology, Henri Mondor Hospital, Creteil, France
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Slim Fourati
iBacteriology-Virology, Henri Mondor Hospital, Creteil, France
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Sukalyani Banik
bCenter for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA
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Padmapriya P. Banada
bCenter for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA
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Shobha Swaminathan
bCenter for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA
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Soumitesh Chakravorty
aCepheid, Sunnyvale, California, USA
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Robert W. Kwiatkowski
aCepheid, Sunnyvale, California, USA
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Victor C. Chu
aCepheid, Sunnyvale, California, USA
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JoAnn Kop
aCepheid, Sunnyvale, California, USA
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Rajiv Gaur
aCepheid, Sunnyvale, California, USA
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Mandy L. Y. Sin
aCepheid, Sunnyvale, California, USA
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Duy Nguyen
aCepheid, Sunnyvale, California, USA
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Simranjit Singh
aCepheid, Sunnyvale, California, USA
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Na Zhang
aCepheid, Sunnyvale, California, USA
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David H. Persing
aCepheid, Sunnyvale, California, USA
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Alexander J. McAdam
Boston Children's Hospital
Roles: Editor
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DOI: 10.1128/JCM.00926-20
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    FIG 1

    Distribution of Xpert Xpress SARS-CoV-2 CT values in concordant positive specimens. Twelve specimens inconclusive by the New York EUA method and 21 specimens tested at Rutgers University Hospital are not included because the EUA version of the Xpert test was used (no RdRp target). The box center lines are medians. The boxes represent upper and lower quartiles. The bars represent minimum and maximum values, except for RdRp NPS/OPS and RdRp TA, where the maximum values are outliers. *, P < 0.0001 for comparison with the E target; **, P = 0.005 for comparison with the E target.

Tables

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  • TABLE 1

    Limits of detection of the Xpert Xpress SARS-CoV-2 test using SARS-CoV-2 in nasopharyngeal-swab clinical matrix

    TABLE 1
  • TABLE 2

    Agreement of Xpert Xpress SARS-CoV-2 test and comparator RT-PCR tests

    TABLE 2
    • ↵a Pos, positive; Neg, negative.

    • ↵b PPA, positive percent agreement {[Pos/Pos ÷ (Pos/Pos + Neg/Pos)] × 100}.

    • ↵c NPA, negative percent agreement {[Neg/Neg ÷ (Neg/Neg + Pos/Neg)] × 100}.

  • TABLE 3

    Specimens with discrepant test results

    TABLE 3
  • TABLE 4

    Distribution of Xpert Xpress SARS-CoV-2 positive results by assay target reactivity

    TABLE 4
    • ↵a Twelve specimens were inconclusive by the New York EUA method, and 21 specimens tested at Rutgers University Hospital are not included because the EUA version of the Xpert test was used (no RdRp target). Both E and N2 targets were detected by the Xpert EUA test in 10 of these specimens, and the N2 target alone and E target alone were each detected in 1 specimen.

Additional Files

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  • Supplemental material

    • Supplemental file 1 -

      Tables S1 and S2

      PDF, 140K

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Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test
Michael J. Loeffelholz, David Alland, Susan M. Butler-Wu, Utsav Pandey, Carlo Frederico Perno, Alice Nava, Karen C. Carroll, Heba Mostafa, Emma Davies, Ashley McEwan, Jennifer L. Rakeman, Randal C. Fowler, Jean-Michel Pawlotsky, Slim Fourati, Sukalyani Banik, Padmapriya P. Banada, Shobha Swaminathan, Soumitesh Chakravorty, Robert W. Kwiatkowski, Victor C. Chu, JoAnn Kop, Rajiv Gaur, Mandy L. Y. Sin, Duy Nguyen, Simranjit Singh, Na Zhang, David H. Persing
Journal of Clinical Microbiology Jul 2020, 58 (8) e00926-20; DOI: 10.1128/JCM.00926-20

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Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test
Michael J. Loeffelholz, David Alland, Susan M. Butler-Wu, Utsav Pandey, Carlo Frederico Perno, Alice Nava, Karen C. Carroll, Heba Mostafa, Emma Davies, Ashley McEwan, Jennifer L. Rakeman, Randal C. Fowler, Jean-Michel Pawlotsky, Slim Fourati, Sukalyani Banik, Padmapriya P. Banada, Shobha Swaminathan, Soumitesh Chakravorty, Robert W. Kwiatkowski, Victor C. Chu, JoAnn Kop, Rajiv Gaur, Mandy L. Y. Sin, Duy Nguyen, Simranjit Singh, Na Zhang, David H. Persing
Journal of Clinical Microbiology Jul 2020, 58 (8) e00926-20; DOI: 10.1128/JCM.00926-20
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    • ABSTRACT
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KEYWORDS

SARS-CoV-2
COVID-19
Xpert
RT-PCR

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