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Epidemiology

Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia

Eliane Rohner, Lisa Rahangdale, Busola Sanusi, Andrea K. Knittel, Laurence Vaughan, Kirsty Chesko, Brian Faherty, Samantha E. Tulenko, John W. Schmitt, LaHoma S. Romocki, Vijay Sivaraman, Julie A. E. Nelson, Jennifer S. Smith
Yi-Wei Tang, Editor
Eliane Rohner
aDepartment of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Lisa Rahangdale
bDepartment of Obstetrics and Gynecology, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
cLineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Busola Sanusi
dDepartment of Biostatistics, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Andrea K. Knittel
bDepartment of Obstetrics and Gynecology, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Laurence Vaughan
eBecton, Dickinson and Company, Sparks, Maryland, USA
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Kirsty Chesko
eBecton, Dickinson and Company, Sparks, Maryland, USA
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Brian Faherty
eBecton, Dickinson and Company, Sparks, Maryland, USA
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Samantha E. Tulenko
aDepartment of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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John W. Schmitt
fDepartment of Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina, USA
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LaHoma S. Romocki
gDepartment of Public Health Education, North Carolina Central University, Durham, North Carolina, USA
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Vijay Sivaraman
hDepartment of Biological and Biomedical Sciences, North Carolina Central University, Durham, North Carolina, USA
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Julie A. E. Nelson
iDepartment of Microbiology and Immunology, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Jennifer S. Smith
aDepartment of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
cLineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Yi-Wei Tang
Cepheid
Roles: Editor
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DOI: 10.1128/JCM.01443-19
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    FIG 1

    Flow diagram showing the number of women eligible for inclusion during the study period and the number of women excluded from the analysis, with reasons.

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  • TABLE 1

    Baseline characteristics of women included in the test accuracy analysis, with valid urine samples, self-collected cervicovaginal samples, and provider-collected cervical samples

    TABLE 1
    • ↵a Other races included American Indian/Alaskan Native (n = 4), Asian (n = 9), black-Indian (n = 1), white-black (n = 1), white-Asian (n = 2), Indian (n = 1), Mediterranean (n = 1), and Native Hawaiian/other Pacific Islander (n = 1).

  • TABLE 2

    Diagnostic test accuracy of the Onclarity hrHPV assay for detection of CIN2+ with different sample types, using the Onclarity CT cutoff value established for provider-collected samples for all sample types

    TABLE 2
    • ↵a A CT cutoff value of ≤34.2 was used for all hrHPV subtypes except for HPV-16, for which the CT cutoff value was set at ≤38.3, according to FDA-approved thresholds for provider-collected specimens.

  • TABLE 3

    Test accuracy of the urine-based Onclarity hrHPV assay for detection of CIN2+ using different assay cutoff values

    TABLE 3
    • ↵a The same CT cutoff value was used for all hrHPV subtypes detected by the Onclarity assay.

  • TABLE 4

    Agreement between Onclarity hrHPV test results for urine samples and those for self-collected cervicovaginal samples or provider-collected cervical samples

    TABLE 4

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      Tables S1 to S6

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Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia
Eliane Rohner, Lisa Rahangdale, Busola Sanusi, Andrea K. Knittel, Laurence Vaughan, Kirsty Chesko, Brian Faherty, Samantha E. Tulenko, John W. Schmitt, LaHoma S. Romocki, Vijay Sivaraman, Julie A. E. Nelson, Jennifer S. Smith
Journal of Clinical Microbiology Feb 2020, 58 (3) e01443-19; DOI: 10.1128/JCM.01443-19

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Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia
Eliane Rohner, Lisa Rahangdale, Busola Sanusi, Andrea K. Knittel, Laurence Vaughan, Kirsty Chesko, Brian Faherty, Samantha E. Tulenko, John W. Schmitt, LaHoma S. Romocki, Vijay Sivaraman, Julie A. E. Nelson, Jennifer S. Smith
Journal of Clinical Microbiology Feb 2020, 58 (3) e01443-19; DOI: 10.1128/JCM.01443-19
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    • ABSTRACT
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KEYWORDS

HPV testing
cervical intraepithelial neoplasia
diagnostic test accuracy
human papillomavirus
self-collection
urine

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