Comparison of the hybrid capture test and polymerase chain reaction in identifying women who have an atypical squamous cell of undetermined significance papanicolaou smear and need colposcopy

Abstract

Objectives: The objective of this study was to detect human papillomavirus (HPV) in women with a newly diagnosed atypical squamous cells of undetermined significance (ASCUS) using the hybrid capture (HC) test and the polymerase chain reaction (PCR). We sought to evaluate the accuracy of both tests in identifying women with a concomitant cervical intraepithelial neoplasia (CIN).

Materials and methods: We studied 360 women who had a diagnosis of ASCUS and were referred to the colposcopy clinic. Subjects were between 18 and 50 years, had newly diagnosed ASCUS, had no history of cervical biopsies or treatment, and were not pregnant. A cell sample for HPV testing and colposcopically directed biopsies of lesions were obtained. HPV was detected using the Digene HC and PCR systems (Digene, Silver Spring, MD).

Results: Biopsies showed concomitant CIN in 80 patients (22.2%). Of these, 19 had CIN2 or CIN3. HPV-DNA was detected in 76 of the 360 women (21.1%) using HC and in 166 of 348 women (47.7%) using PCR. The concordance between HC and PCR for detecting HPV was 65%. The sensitivity, specificity, and positive and negative predictive values of HC for detecting CIN were 48%, 86%, 50%, and 85%, respectively. The sensitivity, specificity, and positive and negative predictive values of PCR for detecting CIN were 67%, 58%, 31%, and 86%, respectively. Focusing on CIN2 and CIN3 alone, these values were 79%, 82%, 20%, and 99% for HC, respectively, and 89%, 55%, 10%, and 99% for PCR, respectively.

Conclusion: The specificity of HC was higher than the specificity of PCR. For this reason, the HC might be more useful than PCR as a secondary triage method for detecting CIN in women who have incident ASCUS and need colposcopy.