Test Accuracy of Human Papillomavirus in Urine for Detection of Cervical Intraepithelial Neoplasia.
Adult
Aged
Biopsy
Colposcopy
DNA, Viral
/ urine
Early Detection of Cancer
Female
Humans
Middle Aged
North Carolina
Papillomaviridae
/ genetics
Papillomavirus Infections
/ diagnosis
Polymerase Chain Reaction
Sensitivity and Specificity
Specimen Handling
Uterine Cervical Neoplasms
/ diagnosis
Uterine Cervical Dysplasia
/ diagnosis
HPV testing
cervical intraepithelial neoplasia
diagnostic test accuracy
human papillomavirus
self-collection
urine
Journal
Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564
Informations de publication
Date de publication:
24 02 2020
24 02 2020
Historique:
received:
01
09
2019
accepted:
12
12
2019
pubmed:
4
1
2020
medline:
1
1
2021
entrez:
4
1
2020
Statut:
epublish
Résumé
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 (
Identifiants
pubmed: 31896666
pii: JCM.01443-19
doi: 10.1128/JCM.01443-19
pmc: PMC7041584
pii:
doi:
Substances chimiques
DNA, Viral
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NIAID NIH HHS
ID : P30 AI050410
Pays : United States
Organisme : NCI NIH HHS
ID : U54 CA156733
Pays : United States
Informations de copyright
Copyright © 2020 American Society for Microbiology.
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