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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.

McLachlin, Catherine M. MD, FRCP(C); Alanen, Ken W. MD; Elit, Laurie M. MD, FRCS(C); Smith, Elizabeth A. MD; Kerkvliet, Nancy A. MLT
Journal of Lower Genital Tract Disease: January 2000
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Objectives. 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.

(C)2000The American Society for Colposcopy and Cervical Pathology