Performance of clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal specimens, and visual inspection of the cervix with acetic acid, for the detection of underlying high-grade squamous intraepithelial lesions in Papua New Guinea

Papillomavirus Res. 2018 Dec;6:70-76. doi: 10.1016/j.pvr.2018.10.009. Epub 2018 Nov 1.

Abstract

The performance of different clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal ('V') specimens, and visual inspection of the cervix with acetic acid (VIA) was evaluated in Papua New Guinea. Women aged 30-59 years provided V specimens that were tested at point-of-care using the Xpert HPV Test (Cepheid, Sunnyvale, CA). A clinician-collected cervical ('C') specimen was then collected for point-of-care Xpert testing, and liquid-based cytology (LBC). Following this, VIA examination was conducted, blind to HPV test results, and ablative cervical cryotherapy provided if indicated. Detection of high-grade squamous intraepithelial lesion (HSIL) by LBC was the reference standard used to evaluate clinical screening algorithms. Of 1005 women, 36 had HSIL+. Xpert HPV Test performance using V specimens (sensitivity 91.7%, specificity 87.0%, PPV 34.0%, NPV 99.3%) was superior to VIA examination alone (51.5%, 81.4%, 17.5%, 95.6% respectively) in predicting underlying HSIL+. A screening algorithm comprising V specimen HPV testing followed by VIA examination had low sensitivity (45.5%) but comparable specificity, PPV and NPV to HPV testing alone (96.3%, 45.5%, 96.3% respectively). A 'test-and-treat' screening algorithm based on point-of-care HPV testing of V specimens had superior performance compared with either VIA examination alone, or a combined screening algorithm comprising HPV testing plus VIA.

Keywords: Cervical cancer; HPV; Papua New Guinea; Screening; Self-collect; Visual inspection with acetic acid.

Publication types

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

MeSH terms

  • Acetic Acid / administration & dosage
  • Adult
  • Algorithms
  • Cervix Uteri / pathology
  • Cytological Techniques / methods*
  • DNA, Viral / genetics
  • DNA, Viral / isolation & purification*
  • Early Detection of Cancer / methods
  • Female
  • Humans
  • Indicators and Reagents
  • Middle Aged
  • Papua New Guinea
  • Point-of-Care Systems*
  • Self-Examination / methods
  • Sensitivity and Specificity
  • Specimen Handling / methods*
  • Squamous Intraepithelial Lesions of the Cervix / diagnosis*
  • Uterine Cervical Neoplasms / diagnosis*
  • Vagina / virology*

Substances

  • DNA, Viral
  • Indicators and Reagents
  • Acetic Acid