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

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 o...

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Bibliographic Details
Published in:Journal of clinical microbiology 2020-02, Vol.58 (3)
Main Authors: Rohner, Eliane, Rahangdale, Lisa, Sanusi, Busola, Knittel, Andrea K, Vaughan, Laurence, Chesko, Kirsty, Faherty, Brian, Tulenko, Samantha E, Schmitt, John W, Romocki, LaHoma S, Sivaraman, Vijay, Nelson, Julie A E, Smith, Jennifer S
Format: Article
Language:English
Subjects:
Adult
Aged
Biopsy
Colposcopy
DNA, Viral - urine
Early Detection of Cancer
Epidemiology
Female
Humans
Middle Aged
North Carolina
Papillomaviridae - genetics
Papillomaviridae - isolation & purification
Papillomavirus Infections - diagnosis
Papillomavirus Infections - pathology
Polymerase Chain Reaction
Sensitivity and Specificity
Specimen Handling
Uterine Cervical Dysplasia - diagnosis
Uterine Cervical Dysplasia - virology
Uterine Cervical Neoplasms - diagnosis
Uterine Cervical Neoplasms - virology
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Summary: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
ISSN:0095-1137
1098-660X
DOI:10.1128/JCM.01443-19