Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study

J Clin Virol. 2022 Oct:155:105271. doi: 10.1016/j.jcv.2022.105271. Epub 2022 Aug 24.

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 <CIN2 (ratio 0.92; 95% CI: 0.84-0.996) compared to cervical samples. HPV test agreement between sample pairs expressed as Cohen's Kappa (κ) was moderate to excellent for overall hrHPV and individual genotypes (or groups) (κ=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.

Keywords: Cervical cancer; Clinical validation; First-void urine; HPV, Diagnostic test accuracy; Self-sampling.

Publication types

  • Clinical Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • DNA, Viral / genetics
  • DNA, Viral / urine
  • Diagnostic Tests, Routine
  • Early Detection of Cancer / methods
  • Female
  • Genotype
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics
  • Papillomavirus Infections*
  • Sensitivity and Specificity
  • Uterine Cervical Dysplasia* / diagnosis
  • Uterine Cervical Neoplasms*

Substances

  • DNA, Viral

Associated data

  • ClinicalTrials.gov/NCT03064087