@article{01H43MMVZCSYAFW6T1TFKMK7XW,
  abstract     = {{Background: : Urine collection is a non-invasive self-sampling method offering the prospect of reaching women un (der)-screened for cervical cancer. The VALHUDES research framework was designed to address the lack of clinical accuracy data for high-risk (hr)HPV testing using urine samples. Objectives: : Here, we report on the analytical and clinical accuracy of hrHPV testing on first-void urine, collected at home, using an extended HPV genotyping assay. Study design: : Paired first-void urine (Colli-Pee with UCM, Novosanis; index test) and clinician-collected cervical samples (Cervex-Brush, Rovers in PreservCyt Solution, Hologic; comparator test) were collected from 492 women aged 19 to 72 years attending colposcopy (reference test, with histology if indicated) (VALHUDES; NCT03064087). Extended HPV genotyping was performed on paired samples with the BD Onclarity HPV Assay. Cut-offs defined for cervical samples were also applied for first-void urine. Results: : HrHPV testing in first-void urine was similarly sensitive for both CIN2+ (ratio 1.00; 95% CI: 0.93-1.07) and CIN3 (ratio 0.98; 95% CI: 0.88-1.08), and marginally less specific for 2 (ratio 0.92; 95% CI: 0.84-0.996) compared to cervical samples. HPV test agreement between sample pairs expressed as Cohen's Kappa (kappa) was moderate to excellent for overall hrHPV and individual genotypes (or groups) (kappa=0.56-0.85). Conclusions: : BD Onclarity HPV Assay on first-void urine has similar clinical sensitivity and somewhat lower specificity to detect cervical precancer to testing on clinician-collected cervical samples.}},
  articleno    = {{105271}},
  author       = {{Van Keer, Severien and  Latsuzbaia, Ardashel and Vanden Broeck, Davy and  De Sutter, Philippe and  Donders, Gilbert and  Doyen, Jean and  Tjalma, Wiebren A. A. and Weyers, Steven and Arbyn, Marc and  Vorsters, Alex}},
  issn         = {{1386-6532}},
  journal      = {{JOURNAL OF CLINICAL VIROLOGY}},
  keywords     = {{Cervical cancer,HPV,Diagnostic test accuracy,Self -sampling,First -void urine,Clinical validation,RISK HUMAN-PAPILLOMAVIRUS,CERVICAL SAMPLES,DNA DETECTION,WOMEN,PREVENTION,VALHUDES}},
  language     = {{eng}},
  pages        = {{8}},
  publisher    = {{Elsevier}},
  title        = {{Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine : a diagnostic test accuracy study}},
  url          = {{http://doi.org/10.1016/j.jcv.2022.105271}},
  volume       = {{155}},
  year         = {{2022}},
}

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