All women were screened using the Pap smear and speculoscopy and combination of both (PapSure examination) in the multicenter trial. Final diagnosis of each patient was based on a histological evaluation of the colposcopic target biopsy. Results were analyzed using a proportional comparison test, sensitivity, specificity, and predictive value with significance determined at p < 0.05.
Of 1813 women screened, 1701 were eligible for analysis. Two hundred and fourteen women (12.6 % ) received at least one positive screening test result. Of the 1084 colposcopic biopsy specimens obtained, 24 showed low-grade squamous intraepithelial lesion (LSIL) and 19 high-grade SIL (HSIL). HSIL were considered test-positive. Rate of colposcopy was 21.5 % (125/582) in the premenopausal group and 63.9 % (321/502) in the postmenopausal group (p < 0.001). For premenopausal women, speculoscopy (75.0 % ) or PapSure (91.7 % ) provided higher sensitivity than Pap smear (50 % ) (p < 0.05). In postmenopausal women, no statistical significance in sensitivity existed between PapSure (85.7 % ) and Pap smear (57.1 % ). Speculoscopy (96.8 % ) or PapSure (96.5 % ) had lower specificity than Pap smear (99.6 % ) (p < 0.001).
PapSure was an accurate alternative screening method to Pap smear or speculoscopy for cervical intraepithelial lesions because of a significantly higher sensitivity along with adequate specificity for premenopausal women; however, PapSure was not a more effective cervical screening method for postmenopausal women.