PapSure Test for Cervical Cancer Detection

Park, Choong Hak; Kim, Hyun Jun; Kwon, Ho Jang

Abstract

OBJECTIVE
The PapSure test, a combination of Papanicolaou smear cytology and speculoscopy, is a direct visual cervical cancer screening method. Speculoscopy, or magnified chemiluminescent examination (MCE), is a new visual method for the detection of cervical neoplasia. It utilizes low magnification and a special "blue-white" chemiluminescent light. The purpose of this study was to evaluate the effectiveness of PapSure test for cervical cancer detection, as compared with the Pap cytology alone.
METHODS
This prospective, randomized, university hospital-based clinical study was performed in the outpatient clinic of the Department of Obstetrics and Gynecology at Dankook University Medical Center from July 1, 2002 to November 30, 2003. Of the 508 patients aged 17-81 years who had undergone conventional Papanicolaou cervical cytologic test, speculoscopy, and colposcopy, 254 cases underwent histopatologic diagnoses.
RESULTS
Of the 508 patients, there were 131 (25.8%) PapSure diagnoses of positive, 377 (74.2%) of negative. Of the 254 histologic diagnoses, there were 166 (65.4%) diagnoses of benign, 37 (14.6%) of LSIL, 30 (11.8%) of HSIL, and 21 (8.3%) of carcinoma. Pap smear showed sensitivity of 79.5%, and specificity of 91.6%, whereas PapSure test showed sensitivity of 89.8%, and specificity of 77.1%. The addition of speculoscopy to the routine Pap smear resulted in finding 2 of the 30 (7%) women with HSIL which was not statistically significant, and 7 of the 28 (25%) women with LSIL which showed statistically borderline significance.
CONCLUSION
PapSure test showed a higher sensitivity rate and a lower false negative rate than Pap smear 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 detecting cervical neoplasia.