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Bacteriology

Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System

C. L. Emery, R. F. Relich, T. H. Davis, S. A. Young, M. D. Sims, B. L. Boyanton Jr.
Paul Bourbeau, Editor
C. L. Emery
aDepartment of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA
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R. F. Relich
aDepartment of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA
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T. H. Davis
aDepartment of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA
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S. A. Young
bTriCore Reference Laboratories and Department of Pathology and Laboratory Medicine, University of New Mexico, Albuquerque, New Mexico, USA
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M. D. Sims
cDepartment of Infectious Diseases, Beaumont Health, Royal Oak, Michigan, USA
eOakland University William Beaumont School of Medicine, Rochester, Michigan, USA
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B. L. Boyanton Jr.
dDepartment of Pathology and Laboratory Medicine, Beaumont Health, Royal Oak, Michigan, USA
eOakland University William Beaumont School of Medicine, Rochester, Michigan, USA
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Paul Bourbeau
Roles: Editor
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DOI: 10.1128/JCM.01324-18
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    FIG 1

    NeuMoDx 288 system.

  • FIG 2
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    FIG 2

    Diagram of workflow for NeuMoDx method comparison study.

Tables

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  • TABLE 1

    Results of prospective sample testing at each laboratory site

    SiteNo. of samples that were:Total% (95% CI)
    True positiveFalse positiveTrue negativeFalse negativeSensitivitySpecificityTotal agreement
    A739263635192.4 (84.4–96.5)96.7 (93.8–98.3)95.7 (91.1–99.4)
    B6219318140098.4 (91.5–99.7)94.4 (91.4–96.4)95.0 (91.1–98.0)
    C1189314144299.2 (95.4–99.9)97.2 (94.8–98.5)97.7 (93.3–101.4)
    Total2533789581,19396.9 (94.1–98.4)96.0 (94.6–97.1)96.2 (93.8–98.3)
  • TABLE 2

    Result agreement between NeuMoDx and BD MAX systemsa

    ParameterNo. of samples testedAgreement (%)
    PPA270/27498.5
    NPA899/91997.8
    Total1,169/1,19398.0
    • ↵a NeuMoDx GBS assay results compared to results obtained from the BD MAX system. PPA, positive percent agreement; NPA, negative percent agreement.

  • TABLE 3

    Combined results of interlaboratory reproducibility studya

    GBS sample panel concentrationAgreement typePerformance requirement (%)NeuMoDx
    % agreement95% CI
    Moderate-positive samples (4× LOD, 95% CI upper limit)Positive (PPA)>99100 (75/75)95.1–100
    Low-positive samples (1.5× LOD, 95% CI upper limit)Positive (PPA)>9597.3 (73/75)90.8–99.3
    Low-negative samples (1:100 dilution of 1× LOD, 95% CI upper limit)Negative (NPA)>9598.7 (74/75)92.8–99.8)
    Negative samples (no target present)Negative (NPA)∼100100 (75/75)95.1–100
    • ↵a The lower and upper limits of the 95% CI were calculated using 95% CI method according to CLSI-approved guideline EP12-A2. LLOD, lower limit of detection; PPA, positive percent agreement; NPA, negative percent agreement.

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Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System
C. L. Emery, R. F. Relich, T. H. Davis, S. A. Young, M. D. Sims, B. L. Boyanton Jr.
Journal of Clinical Microbiology Jan 2019, 57 (2) e01324-18; DOI: 10.1128/JCM.01324-18

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Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System
C. L. Emery, R. F. Relich, T. H. Davis, S. A. Young, M. D. Sims, B. L. Boyanton Jr.
Journal of Clinical Microbiology Jan 2019, 57 (2) e01324-18; DOI: 10.1128/JCM.01324-18
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    • ABSTRACT
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KEYWORDS

GBS
group B Streptococcus
Lim broth
neonatal sepsis
real-time PCR

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