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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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ABSTRACT

The objective was to assess the diagnostic test accuracy of high-risk human papillomavirus (hrHPV) testing of self-collected urine and cervicovaginal samples for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). We recruited a convenience sample of women 25 to 65 years of age who were undergoing clinically indicated colposcopy at two medical centers in North Carolina between November 2016 and January 2019. Women with normal cytology results and positive hrHPV results were also recruited. Urine samples, self-collected cervicovaginal samples, provider-collected cervical samples, and cervical biopsy samples were obtained from all enrolled women. Samples were tested for hrHPV DNA using the Onclarity assay (Becton Dickinson, Sparks, MD). Biopsy samples were histologically graded as CIN2+ or <CIN2. We calculated the sensitivity and specificity for detection of CIN2+ and assessed agreement between sample collection methods. We included 307 women (median age, 36 years) with valid histology results and triple-matched urine, self-collected cervicovaginal, and provider-collected cervical hrHPV results; 83 women (27%) had CIN2+. Urine-based hrHPV testing correctly identified 80% of CIN2+ cases (95% confidence interval [CI], 71 to 88%) using the PCR cycle threshold (CT) established for provider-collected cervical samples, but sensitivity remained below the estimates for self-collected cervicovaginal and provider-collected cervical samples (both 94% [95% CI, 89 to 99%]). Using a higher CT cutoff value of ≤40, 90% sensitivity was achieved for urine-based hrHPV testing. Agreement between results for urine samples and self-collected cervicovaginal samples (kappa = 0.58) or provider-collected cervical samples (kappa = 0.54) was moderate. Urine-based hrHPV testing may be a promising approach to improve cervical cancer screening coverage, especially among women with limited access to health care.

FOOTNOTES

    • Received 1 September 2019.
    • Returned for modification 30 September 2019.
    • Accepted 12 December 2019.
    • Accepted manuscript posted online 2 January 2020.
  • Supplemental material is available online only.

  • Copyright © 2020 American Society for Microbiology.

All Rights Reserved.

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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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KEYWORDS

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

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