Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions

J Clin Virol. Feb-Mar 2018;99-100:22-30. doi: 10.1016/j.jcv.2017.12.008. Epub 2017 Dec 21.

Abstract

Background: Comparative data on different self-collection methods is limited.

Objectives: To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions.

Study design: Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn®Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt® buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas® 4800 HPV Test and Xpert®HPV.

Results: Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn®Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas® 0.96; Xpert®HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas® 0.92; Xpert®HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs™ was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn®Brush or FLOQSwabs™ was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs™ when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn®Brush easier and more comfortable than FLOQSwabs™.

Conclusions: Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used.

Trial registration: ClinicalTrials.gov NCT02945891.

Keywords: Acceptability; Device; HPV test; Performance; Self-sampling; Vaginal smear.

Publication types

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

MeSH terms

  • Adult
  • Cervical Intraepithelial Neoplasia / diagnosis*
  • Female
  • Humans
  • Papillomaviridae*
  • Papillomavirus Infections / diagnosis*
  • Reagent Kits, Diagnostic
  • Safety
  • Self Administration
  • Sensitivity and Specificity
  • Uterine Cervical Neoplasms / diagnosis*
  • Vaginal Smears / instrumentation*
  • Vaginal Smears / standards*

Substances

  • Reagent Kits, Diagnostic

Associated data

  • ClinicalTrials.gov/NCT02945891