HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal Cytology.
Adult
Aged
Aged, 80 and over
Colposcopy
Female
Genotype
Human papillomavirus 16
/ genetics
Human papillomavirus 18
/ genetics
Humans
Middle Aged
Papillomaviridae
/ genetics
Papillomavirus Infections
/ diagnosis
Prevalence
Risk
Sensitivity and Specificity
Uterine Cervical Neoplasms
/ diagnosis
Uterine Cervical Dysplasia
/ diagnosis
Adjunct testing
Cervical cancer screening
Cervical intraepithelial neoplasia
Cotesting
Genotype
Human papillomavirus
Negative for intraepithelial lesions and malignancies
Journal
American journal of clinical pathology
ISSN: 1943-7722
Titre abrégé: Am J Clin Pathol
Pays: England
ID NLM: 0370470
Informations de publication
Date de publication:
01 03 2019
01 03 2019
Historique:
pubmed:
17
1
2019
medline:
31
12
2019
entrez:
17
1
2019
Statut:
ppublish
Résumé
To determine the BD Onclarity human papillomavirus (HPV) assay performance and risk values for cervical intraepithelial neoplasia grade 2 (CIN2) or higher and cervical intraepithelial neoplasia grade 3 (CIN3) or higher during Papanicolaou/HPV cotesting in a negative for intraepithelial lesions or malignancies (NILM) population. In total, 22,383 of the 33,858 enrolled women were 30 years or older with NILM cytology. HPV+ and a subset of HPV- patients (3,219/33,858 combined; 9.5%) were referred to colposcopy/biopsy. Overall, 7.9% of women were Onclarity positive; HPV 16 had the highest prevalence (1.5%). Verification bias-adjusted (VBA) CIN2 or higher and CIN3 or higher prevalences were 0.9% and 0.3%, respectively. Onclarity had VBA CIN2 or higher (44.1%) and CIN3 or higher (69.5%) sensitivities, as well as CIN2 or higher (92.4%) and CIN3 or higher (92.3%) specificities-all similar to Hybrid Capture 2. HPV 16, 18, 45, and the other 11 genotypes had CIN3 or higher risks of 6.9%, 2.6%, 1.1%, and 2.2%, respectively. Onclarity is clinically validated for cotesting in NILM women. Genotyping actionably stratifies women at greater CIN3 or higher risk.
Identifiants
pubmed: 30649177
pii: 5289258
doi: 10.1093/ajcp/aqy169
pmc: PMC6396747
doi:
Banques de données
ClinicalTrials.gov
['NCT01944722']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
433-442Informations de copyright
© American Society for Clinical Pathology, 2019.
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