Unsatisfactory SurePath Liquid-based Papanicolaou Tests Causes and Significance

BACKGROUND: The introduction of liquid-based Papanicolaou (Pap) tests (LBPTs) has reduced the incidence of unsatisfactory Pap tests (UPTs), but little is known about their causes and significance, especially in the case of SurePath LBPTs. METHODS: All unsatisfactory LBPTs from January 1, 2003 to December 31, 2006 were retrieved. The characteristics of patients, providers, and LBPTs; the reason for UPTs; and any cytologic or histologic follow-up within 24 months were recorded. Negative Pap tests that were evaluated immediately after a UPT served as a control group. RESULTS: Of 243,006 Pap tests (95.5% SurePath LBPTs), 0.23% were unsatisfactory. Scant cellularity was the primary cause of SurePath UPT. Women in this UPT group were older, had more diagnostic Pap tests taken, less frequently were taking contraceptives or were pregnant, and were more likely to be menopausal or posthysterectomy. The 278 women who had UPTs had significantly higher rates of follow-up Pap tests (65.1% vs 22.2%), abnormal Pap tests (5.4% vs 1.4%), biopsies (10% vs 1%), and abnormal biopsies (5% vs 1%) than the 284 women in the control group, including 7 women with cervical intraepithelial neoplasia 1 (CIN-1), 1 woman with CIN-2, 4 women with CIN-3, and 2 women with endometrial hyperplasia. The UPT rates varied little between provider groups (physicians vs nonphysicians and gynecologists vs nongynecologists). CONCLUSIONS: The frequency of UPTs in a predominantly SurePath LBPT-screened population was very low and was caused mainly by low cellularity. Similar to conventional Pap smears, unsatisfactory SurePath LBPTs had a higher risk of significant histologic abnormalities on follow-up than negative satisfactory Pap tests and could have benefited from a repeat Pap test or other evaluation, according to current management guidelines. Cancer (Cancer Cytopathol) 2009;117:15-26. (C) 2009 American Cancer Society.