title: Hybrid Capture Human Papillomavirus Testing as an Adjunct to the Follow-Up of Patients with ASCUS and LGSIL Pap Smears: A Study of a Screening Population.
abstract: OBJECTIVE
  We set out to evaluate Hybrid Capture (Digene Corporation, Silver Spring, MD) testing for human papillomavirus (HPV) in the management of a screening population with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LGSIL).
  
  
  METHODS
  A total of 619 patients with ASCUS or LGSIL Papanicolaou smears were tested for high-risk HPV types. They then were followed at 6-month intervals with Papanicolaou smears and repeat HPV testing. Patients with persistent or progressive disease were referred for colposcopy. HPV results were compared to the most significant follow-up cytological or colposcopic diagnosis to determine whether Hybrid Capture HPV testing was predictive of outcome. A cost analysis was performed.
  
  
  RESULTS
  Follow-up of 12 to 30 months was available for 471 patients (76.1%). Outcome diagnoses for 190 patients who initially tested HPV-positive were as follows: 49% benign, 14% ASCUS, 19% LGSIL, 18% HGSIL, and 0.5% cancer. For 281 patients who initially tested HPV-negative, outcomes were 77% benign, 14% ASCUS, 6% LGSIL, 2% HGSIL, and 0.3% cancer. Twenty-six of the patients with HGSIL had two or more HPV tests, and all these patients had at least one positive result.
  
  
  CONCLUSIONS
  Hybrid Capture testing for high-risk HPV types was predictive of which patients presenting with ASCUS/LGSIL would persist or progress to HGSIL (p < .001). The cost of adding Hybrid Capture testing was intermediate between the cost of cytological follow-up and referral of all patients with ASCUS/LGSIL to colposcopy.
authors.affiliation: Departments of *Pathology and †Obstetrics and Gynecology, London Health Sciences Centre and the University of Western Ontario, and the ‡Middlesex-London Health Unit, London, Ontario, Canada.
authors.forename: C M
authors.initials: CM
authors.lastname: McLachlin
authors.forename: K W
authors.initials: KW
authors.lastname: Alanen
authors.forename: L M
authors.initials: LM
authors.lastname: Elit
authors.forename: E A
authors.initials: EA
authors.lastname: Smith
authors.forename: N A
authors.initials: NA
authors.lastname: Kerkvliet