Human papillomavirus deoxyribonucleic acid detection in mildly or moderately dysplastic smears: a possible method for selecting patients for colposcopy.

OBJECTIVE Current screening protocols for cervical cancer dictate that patients with smears read as mild or moderate dysplasia of the uterine cervix undergo colposcopy, although approximately half these women do not prove to have high-grade squamous intraepithelial lesions. The aim of this study was to determine whether human papillomavirus testing is capable of discriminating between high- and low-grade squamous intraepithelial lesions so as to be useful in reducing the number of colposcopic examinations. STUDY DESIGN We tested 190 consecutive patients with smears read as mild or moderate dysplasia for the presence of human papillomavirus deoxyribonucleic acid by use of two different polymerase chain reactions with the consensus primer pairs CPI/IIG and MY09/11. Typing was carried out by direct sequence analysis of the CPI/IIG amplimers. The MY09/11 amplimers were detected in enzyme-linked immunosorbent assay format with the SHARP (Solution Hybridization Assay for PCR Products) Signal System with two probe mixtures (A and B) to detect nononcogenic and oncogenic human papillomavirus types. The human papillomavirus test results were compared with the histologic diagnosis, which was regarded as the reference standard. RESULTS Fifty-six of the 190 patients had high-grade squamous intraepithelial lesions. The sensitivity was 96% for the CPI/IIG test and 95% for the MY09/11 polymerase chain reaction plus SHARP Signal System when probe B only was used. The specificity was 33% for the CPI/IIG test and 40% for the MY09/11 polymerase chain reaction plus SHARP Signal System when probe B was used. CONCLUSION A negative CPI/IIG or SHARP Signal System probe B test can select, respectively, 44 or 54 of the 134 patients without high-grade squamous intraepithelial lesions. The use of these human papillomavirus tests as a secondary triage in patients with smears that were read as mild or moderate dysplasia could prevent those patients from undergoing unnecessary colposcopy. However, respectively, 2 or 3 of the 56 patients who have high-grade squamous intraepithelial lesions would be missed by human papillomavirus testing.