An Evaluation of the Cobas4800 HPV Test on Cervico-Vaginal Specimens in Liquid versus Solid Transport Media

PLoS One. 2016 Feb 1;11(2):e0148168. doi: 10.1371/journal.pone.0148168. eCollection 2016.

Abstract

Objectives: Determine the ability of the Cobas 4800 assay to detect high-risk human papillomavirus (HrHPV) and high-grade cervical lesions when using cervico-vaginal samples applied to liquid medium and solid media cards compared to a direct cervical sample.

Methods: Two cervico-vaginal specimens (pseudo self-collected) were obtained from 319 women. One was applied to an iFTA Card (FTA) then the brush placed in liquid-based medium (LSELF); the other was applied to a new solid media: POI card (POI). The clinical performance of Cobas4800 assay using the three aforementioned specimens was compared to direct collected endocervical specimens in liquid media (LDOC).

Results: The overall agreements of HrHPV detection were 84.2% (LSELF vs. LDOC), 81.0% (FTA vs. LDOC), and 82.3% (POI vs. LDOC). LSELF, FTA and POI identified 98.0%, 79.6%, and 97.5% positive cases of LDOC. Sensitivity to identify CIN2+ were 98.4% (LSELF), 73.8% (FTA), 95.1% (POI), and 93.4% (LDOC) respectively. FTA had 78.1% and 90.4% agreement with the LSELF samples for all HrHPV and HPV16/18 detection respectively, while POI had 91.6% for both.

Conclusions: Cobas4800 HPV test combined with cervico-vaginal specimens applied to both liquid media and POI solid card are accurate to detect HrHPV infection and high-grade cervical lesions as compared with direct endocervical samples in liquid media.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Biological Assay
  • Cervix Uteri / pathology
  • Cervix Uteri / virology*
  • Culture Media
  • Diagnostic Techniques and Procedures*
  • Endpoint Determination
  • Female
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics
  • Papillomaviridae / physiology*
  • Papillomavirus Infections / diagnosis*
  • Uterine Cervical Dysplasia / diagnosis
  • Uterine Cervical Dysplasia / pathology
  • Uterine Cervical Dysplasia / virology
  • Vagina / pathology
  • Vagina / virology*
  • Young Adult

Substances

  • Culture Media

Grants and funding

The study was supported by Shenzhen Municipal Science and Technical Innovation Committee, Shenzhen, PR China (No. JCYJ20140415162338808 & No. GJHZ20130417100103783); and by Preventive Oncology International, Inc., Cleveland, Heights, Ohio, USA. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.