Comparative performance of human papillomavirus messenger RNA versus DNA screening tests at baseline and 48 months in the HPV FOCAL trial.

Autor: Cook DA; BC Centre for Disease Control, Vancouver, BC, Canada; BC Cancer Agency, Vancouver, BC, Canada., Smith LW; BC Cancer Agency, Vancouver, BC, Canada., Law JH; Lower Mainland Pathology & Laboratory Medicine, Provincial Health Services Authority, Vancouver, BC, Canada., Mei W; Lower Mainland Pathology & Laboratory Medicine, Provincial Health Services Authority, Vancouver, BC, Canada., Gondara L; BC Cancer Agency, Vancouver, BC, Canada., van Niekerk DJ; BC Cancer Agency, Vancouver, BC, Canada; Lower Mainland Pathology & Laboratory Medicine, Provincial Health Services Authority, Vancouver, BC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada., Ceballos KM; BC Cancer Agency, Vancouver, BC, Canada; Lower Mainland Pathology & Laboratory Medicine, Provincial Health Services Authority, Vancouver, BC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada., Jang D; McMaster University/St. Joseph's Healthcare, Hamilton, ON, Canada., Chernesky M; McMaster University/St. Joseph's Healthcare, Hamilton, ON, Canada., Franco EL; Division of Cancer Epidemiology, McGill University, Montreal, QC, Canada., Ogilvie GS; BC Centre for Disease Control, Vancouver, BC, Canada; BC Cancer Agency, Vancouver, BC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada., Coldman AJ; BC Cancer Agency, Vancouver, BC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada., Krajden M; BC Centre for Disease Control, Vancouver, BC, Canada; Lower Mainland Pathology & Laboratory Medicine, Provincial Health Services Authority, Vancouver, BC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: mel.krajden@bccdc.ca.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2018 Nov; Vol. 108, pp. 32-37. Date of Electronic Publication: 2018 Sep 10.
DOI: 10.1016/j.jcv.2018.09.004
Abstrakt: Background: HPV FOCAL is a randomized trial comparing high-risk HPV [Hybrid Capture 2 (HC2)] vs. liquid-based cytology (LBC) for primary cervical screening.
Objective: The present study objective was to compare Aptima HPV (AHPV) and HC2 assay performance at the intervention arm baseline and 48 mo. screens in relation to the rates of cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+).
Study Design: Women enrolled after December 2010 (n = 3475) were screened at baseline with both AHPV and HC2 (AHPV was blinded). Women with CIN2+ exited the trial; HC2 negative (-) women and those HC2 positive (+) with Results: At baseline, 7.2% were AHPV + vs. 8.4% for HC2 (p = 0.06). Round 1 AHPV CIN2+ sensitivity (relative to HC2) was 96.0% (95%CI: 86.5-99.0; p = 0.15) and 100% (95%CI: 82.4-100) for CIN3+. AHPV and HC2 specificities (Conclusions: There was no significant difference in CIN2+ detection for AHPV vs. HC2 at baseline or at 48 mo. Baseline AHPV- and HC2- women had similar CIN2+ rates at 48 mo., demonstrating the safety of a four year screening interval for AHPV- women.
(Copyright © 2018. Published by Elsevier B.V.)
Databáze: MEDLINE
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