title: 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.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cytopathology Unit, Department of Clinical and Experimental Sciences, G. d'Annunzio University of Chieti-Pescara, Via dei Vestini, 66100, Chieti, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Zappacosta
authors.forename: Daniela Maria Pia
authors.initials: DM
authors.lastname: Gatta
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Marinucci
authors.forename: Serena
authors.initials: S
authors.lastname: Capanna
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lattanzio
authors.forename: Donatella
authors.initials: D
authors.lastname: Caraceni
authors.forename: Sandra
authors.initials: S
authors.lastname: Rosini
mesh_terms: D000328:Adult; D065309:Atypical Squamous Cells of the Cervix; D003127:Colposcopy; D003362:Cost-Benefit Analysis; D055088:Early Detection of Cancer / Q000191:economics*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000191:economics; D027383:Papillomaviridae / Q000235:genetics; D050725:Papillomavirus E7 Proteins / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis*; D012333:RNA, Messenger / Q000235:genetics; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000175:diagnosis* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology
chemical_list: D050725:Papillomavirus E7 Proteins; D012333:RNA, Messenger
keywords: ASCUS and LSIL; E6/E7 HPV-mRNA test; ICER; cost–effectiveness analysis; human papillomavirus; persistent HPV infections; triage test