Performance of Xpert HPV on Self-collected Vaginal Samples for Cervical Cancer Screening Among Women in South Africa.
Journal
Journal of lower genital tract disease
ISSN: 1526-0976
Titre abrégé: J Low Genit Tract Dis
Pays: United States
ID NLM: 9704963
Informations de publication
Date de publication:
01 Jan 2021
01 Jan 2021
Historique:
pubmed:
27
10
2020
medline:
9
9
2021
entrez:
26
10
2020
Statut:
ppublish
Résumé
Self-sampling may increase access to cervical cancer screening in low-resource settings. Using Xpert HPV, we compared test performance of self- and clinician-collected samples in HIV-positive and HIV-negative women in South Africa. Three hundred thirty HIV-positive and 375 HIV-negative women in the screening group and 202 HIV-negative and 200 HIV-positive women in the referral group, aged 30-65 years, participated in the study. All women self-collected a vaginal sample, and then, a cervical sample was collected by a clinician (both tested using Xpert HPV), followed by colposcopic examination and collection of histologic specimens. There was good agreement between self- and clinician-collected samples for detection of any high-risk human papillomavirus (HPV, κ = 0.72 [95% CI = 0.669-0.771]). Prevalence of HPV and sensitivity of the test to detect cervical intraepithelial neoplasia 2+ was similar in self- and clinician-collected samples. Specificity was lower in self-collected than in clinician-collected samples in both HIV-negative (self: 77.5% [95% CI = 72.8-81.8] vs clinician: 86.9% [95% CI = 82.9-90.2]) and HIV-positive (self: 44.0% [95% CI = 38.0-50.1] vs clinician: 59.7% [95% CI = 53.6-65.6]) women. Restricting the definition of screen-positive to 3 of 5 channels on HPV Xpert improved specificity in both HIV-negative (self: 83.2% [95% CI = 78.8-87.0] vs clinician: 89.7% [95% CI = 86.1-92.7]) and HIV-positive (self: 54.2% [95% CI = 48.1-60.2] vs clinician: 67.4% [95% CI = 61.5-72.9]) women. The self-collected sample had good agreement with the clinician-collected sample for the detection of HPV, and restricting the HPV types may improve the specificity in HIV-positive women.
Identifiants
pubmed: 33105451
pii: 00128360-202101000-00003
doi: 10.1097/LGT.0000000000000575
pmc: PMC7748046
mid: NIHMS1632427
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
15-21Subventions
Organisme : NCI NIH HHS
ID : UH2 CA189908
Pays : United States
Organisme : NCI NIH HHS
ID : UH3 CA189908
Pays : United States
Informations de copyright
Copyright © 2020, ASCCP.
Déclaration de conflit d'intérêts
CSB, DP, and SC declare that they receive salary, benefits, and equity from Danaher Corp. Cepheid is a wholly owned entity of Danaher Corporation. TCW reports that he serves as a consultant in clinical trial design and as an expert pathologist for human papillomavirus vaccine or diagnostic trials for Becton Dickinson, BD Life Sciences-Diagnostic Systems, Roche, and Inovio Pharmaceuticals and as a speaker for Roche and Becton Dickinson, and BD Life Sciences-Diagnostic Systems. The other authors have declared they have no conflicts of interest.
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