Clinical evaluation of high-risk HPV detection on self-samples using the indicating FTA-elute solid-carrier cartridge

J Clin Virol. 2013 Jun;57(2):125-9. doi: 10.1016/j.jcv.2013.02.016. Epub 2013 Mar 19.

Abstract

Background: High-risk human papillomavirus (hrHPV) testing in cervical screening is usually performed on physician-taken cervical smears in liquid-based medium. However, solid-state specimen carriers allow easy, non-hazardous storage and transportation and might be suitable for self-collection by non-responders in screening and in low-resource settings.

Objectives: We evaluated the adequacy of self-collected cervicovaginal (c/v) samples using a Viba-brush stored on an Indicating FTA-elute cartridge (FTA-based self-sampling) for hrHPV testing in women referred to a gynecology clinic due to an abnormal smear.

Study design: 182 women accepted to self-collect a c/v sample. After self-sampling, a physician obtained a conventional liquid-based cervical smear. Finally, women were examined by colposcopy and a biopsy was taken when clinically indicated. Self-samples required only simple DNA elution, and DNA was extracted from physician-obtained samples. Both samples were tested for 14 hrHPVs by GP5+/6+-EIA-LQ Test and SPF(10)-DEIA-LiPA(25).

Results: Both assays detected significantly more hrHPV in physician-collected specimens than in self-collected samples (75.3% and 67.6% by SPF(10); 63.3% and 53.3% by GP5+/6+, respectively). The combination of physician-collected specimen and GP5+/6+ testing demonstrated the optimal balance in sensitivity (98.0%) and specificity (48.1%) for CIN2+ detection in this referral population. A test system of FTA-based self-collection and SPF(10) hrHPV detection approached this sensitivity (95.9%) and specificity (42.9%).

Conclusions: These results show that the clinical performance of hrHPV detection is determined by both the sample collection system and the test method. FTA-based self-collection with SPF(10) testing might be valuable when a liquid-based medium cannot be used, but requires further investigation in screening populations.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Cervical Intraepithelial Neoplasia / diagnosis
  • Cervical Intraepithelial Neoplasia / virology
  • Cervix Uteri / virology*
  • DNA, Viral / genetics
  • Female
  • Genotype
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Papillomavirus Infections / virology
  • Polymerase Chain Reaction
  • Self Administration*
  • Sensitivity and Specificity
  • Specimen Handling / instrumentation*
  • Specimen Handling / methods
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears / instrumentation
  • Vaginal Smears / methods*
  • Young Adult

Substances

  • DNA, Viral