Open AccessHigh-risk human papillomavirus testing in women with ASCUS cytology: results from The ATHENA HPV study
Author(s) -
Mark H. Stoler,
Thomas Wright,
Abha Sharma
Publication year - 2021
Publication title -
reproduktivnaâ èndokrinologiâ
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.106
H-Index - 2
eISSN - 2411-1295
pISSN - 2309-4117
DOI - 10.18370/2309-4117.2021.57.93-98
Subject(s) - ascus (bryozoa) , colposcopy , medicine , gynecology , human papillomavirus , obstetrics , cervical intraepithelial neoplasia , cytology , genotyping , cervical cancer , genotype , cancer , biology , pathology , biochemistry , botany , ascospore , spore , gene
This study evaluated the clinical performance of the cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA, USA) for high-risk human papillomavirus (HR-HPV) testing with individual HPV-16/HPV-18 genotyping in women 21 years or older with atypical squamous cells of undetermined significance (ASCUS). Women (N = 47,208) were recruited in the United States during routine screening, and liquid-based cytology and HPV testing were performed. The ASCUS prevalence was 4.1% (1,923/47,208), and 1,578 women underwent colposcopy with valid results. The cobas 4800 HPV Test demonstrated performance comparable to the Hybrid Capture 2 test (QIAGEN, Gaithersburg, MD, USA) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse and grade 3 or worse. HPV-16/HPV-18+ women had a greater absolute risk of CIN 2 or worse compared with pooled HR-HPV+ and HR-HPV- women (24.4%, 14.0%, and 0.8%, respectively).The cobas 4800 HPV Test is clinically validated for ASCUS triage. HPV-16/HPV-18 genotyping can identify women at highest risk for high-grade cervical disease, and this additional risk stratification may be used in formulating patient management decisions.