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

Testing for human papillomavirus (HPV) as a adjunct to the Pap smear in cervical cancer screening programs has been suggested as a means of predicting which cervical abnormality will progress to cancer. In this study, 619 women with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LGSIL) diagnosed over an 18-month period were evaluated for high-risk HPV types using first-generation Hybrid Capture testing (Digene Corporation, Silver Spring, MD). All patients were followed up conservatively at 6-month intervals with repeated Pap testing. Patients with progressive or persistent disease (three consecutive findings of ASCUS or LGSIL) were referred for colposcopy, and the colposcopic findings were compared with the results of HPV testing. At the end of the study, the most severe cytologic or histologic diagnosis was used as the final diagnosis for patients who did not undergo colposcopy. One hundred thirty-five of the 197 women with LGSIL (69 percent) were positive for HPV. One hundred seven HPV-positive and 49 HPV-negative patients in this group returned for follow-up and were available for evaluation. Fifty-six HPV-positive patients were referred for colposcopy during the course of the study. Normal or low-grade changes were found in 32 of these women, but 23 (21 percent) were diagnosed with high-grade squamous intraepithelial lesions (HGSIL). One HPV-positive woman with a smear indicating LGSIL was found to have invasive cancer at colposcopy. Seventeen of the 49 HPV-negative women were referred for colposcopy, and only 3 (6 percent) were found to have high-grade disease. Of the 422 patients with an initial diagnoses of ASCUS, 116 (28 percent) were HPV positive. Follow-up information was available for 83 patients, of whom 25 were referred for colposcopy. In this group, 7 patients were diagnosed with LGSIL, and 10 were found to have HGSIL. Cancer did not develop in any of these patients. There were 232 HPV-negative patients with ASCUS who returned for follow-up; 34 underwent colposcopy. Six women with ASCUS were negative for HPV but were diagnosed with LGSIL, and four were identified as having HGSIL. One woman who presented with a Pap smear indicating ASCUS was HPV negative but had invasive cancer. Altogether, 37.3 percent of the patients who tested positive for HPV had LGSIL, HGSIL, or cancer, compared with 8.5 percent of those who were negative for HPV (P < .001). Overall, 83 percent of the women with high-grade lesions tested positive for high-risk HPV types on their initial visit. If positive HPV results had been used as the referral criterion, 40 percent of the women would have been referred for colposcopy. When Hybrid Capture HPV testing was performed multiple times, persistent positivity was more predictive of a final diagnosis of HGSIL or LGSIL than a single positive result (P = .04). In fact, of the seven initially HPV-negative patients who eventually progressed to HGSIL, four underwent multiple HPV tests and all converted to positive. When a cost analysis of this study was performed, referral of all patients with ASCUS or higher to colposcopy had a cost of $123,800, cytologic follow-up with referral for persistent or progressive disease had a cost of $81,860, and referral based on HPV Hybrid Capture HPV positive results had a total cost of $98,795. There were no patients lost to follow-up with the immediate colposcopy strategy; 148 were lost using cytological follow-up only (actual study); and 88 would be lost to follow-up if the HPV testing triage strategy were used. J Lower Genital Tract Dis 2000;4:12–17

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