Role of E6/E7 mRNA test in the diagnostic algorithm of HPV-positive patients showing ASCUS and LSIL: clinical and economic implications in a publicly financed healthcare system

Expert Rev Mol Diagn. 2015 Jan;15(1):137-50. doi: 10.1586/14737159.2015.961915. Epub 2014 Sep 22.

Abstract

Objective: Colposcopy is widely used to triage women with mild cervical abnormalities. However, this approach is associated with low specificity and predictive value. The efficacy of E6/E7 mRNA test for this purpose has been demonstrated, but studies estimating its cost-effectiveness are still lacking. Given the limited healthcare financial resources, such an evaluation is a priority.

Methods: We analyzed the clinical history of 432 women referred to colposcopy and colposcopy-directed biopsy for persisting ASCUS and LSIL, and compared three alternative triage protocols: immediate colposcopy; reflex HPV DNA testing and HPV DNA plus mRNA tests in sequence.

Results: Molecular tests in sequence significantly reduce colposcopy referral, cost for assessed women, and cost for CIN2 detected. On the other hand, incremental cost-effectiveness ratio of this protocol was the highest.

Conclusion: Our preliminary data, providing an estimation of the economic burden deriving from the introduction of E6/E7 mRNA test in the triage algorithm of patients with mild cervical abnormalities, may be useful for future healthcare policy.

Keywords: ASCUS and LSIL; E6/E7 HPV-mRNA test; ICER; cost–effectiveness analysis; human papillomavirus; persistent HPV infections; triage test.

MeSH terms

  • Adult
  • Atypical Squamous Cells of the Cervix*
  • Colposcopy
  • Cost-Benefit Analysis
  • Early Detection of Cancer / economics*
  • Female
  • Humans
  • Middle Aged
  • Molecular Diagnostic Techniques / economics
  • Papillomaviridae / genetics
  • Papillomavirus E7 Proteins / genetics
  • Papillomavirus Infections / diagnosis*
  • RNA, Messenger / genetics
  • Squamous Intraepithelial Lesions of the Cervix / diagnosis*
  • Squamous Intraepithelial Lesions of the Cervix / virology
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / virology

Substances

  • Papillomavirus E7 Proteins
  • RNA, Messenger