The purpose of this study was to evaluate the effectiveness of PapSure test, a combination of Papanicolaou smear cytology and speculoscopy, for cervical cancer screening, as compared with the Pap cytology alone.

This prospective, randomized clinical study was performed in Gynecologic Oncology Clinic of the Department of Obstetrics and Gynecology at Dankook University Medical Center from June 1, 2003 to December 31, 2003. Of the 200 patients aged 22-81 years who had undergone conventional Papanicolaou cervical cytologic test and speculoscopy, 116 cases underwent histopathologic diagnoses by colposcopy-directed biopsy and/or endocervical curettage.

Of the 200 patients, there were 45 (22.5%) PapSure diagnoses of positive, 155 (77.5%) of negative. Of the 116 histopathologic diagnoses, there were 88 (75.9%) diagnoses of negative, 10 (8.6%) of LSIL, 10 (8.6%) of HSIL, and 8 (6.9%) of carcinoma. Pap smear cytology showed sensitivity of 71.4%, specificity of 94.3%, and false negative rate of 28.6%. Whereas PapSure test showed sensitivity of 92.9%, specificity of 80.7%, and false negative rate of 7.1%. The addition of speculoscopy to the routine traditional Pap smear resulted in finding 3 of the 10 (30%) women with HSIL, and 3 of the 10 (30%) women with LSIL, although they were not statistically significant.

PapSure test showed a higher sensitivity rate and a lower false negative rate than Pap smear cytology only as a screening test. Pap smear cytology and speculoscopy seem to be additive, and so the PapSure test is thought to be a very effective method for cervical cancer screening.