Improvement of Pap smear sensitivity using a visual adjunctive procedure: a co-operative Italian study on speculoscopy (GISPE).

The present study evaluates whether speculoscopy, a magnified chemiluminescence examination, combined with Pap smear can improve the detection of cervical lesions, as compared with Pap smear alone. The investigation was a prospective practice-based research carried out as a multicentre cohort study throughout the Italian territory. The participants were 3,300 asymptomatic women age > or = 18 years undergoing routine pelvic and cytological screening. All participants were subjected to Pap smear, speculoscopy and colposcopy investigations in succession. The 646 women with positive colposcopy underwent biopsy. Of the 267 women with positive histology 25 were high-grade intraephitelial lesions (HGSIL) and 242 were low-grade intraephitelial lesions (LGSIL). The histological findings were correlated with the results of Pap smear and speculoscopy alone and combined (PPS). Pap smear alone detected 76% of HGSIL, speculoscopy alone identified 84% of HGSIL, and PPS indicated 100% HGSIL. Of the 242 women with LGSIL, Pap smear alone detected 37% of the cases, speculoscopy alone detected 54% of the cases, and PPS identified 91% of the cases. Together, the two tests missed 9% of the LGSIL. The combination PPS was found to increase sensitivity from 40% to 92%, but to lower specificity from 94% to 23%. Speculoscopy combined with Pap smear can yield a higher percentage of women with biopsy-confirmed cervical pathology than the use of Pap smear as a sole screening test. This is particularly true of patients with LGSIL. The mechanisms of pathological detection and the use of speculoscopy should be investigated further.