Abstract

Abstract Objective To assess whether the use of optical detection system (ODS) as an adjunct to colposcopy increases the detection of biopsy confirmed CIN 2, 3 in women being evaluated for an abnormal cervical cytology. Methods This is a comparative study comparing the use of colposcopy alone with the use of colposcopy plus ODS system. Three hundred and six women were recruited from the out patient clinic of Suzan Mobark hospital, Minia University, referred to the Early Cancer Detection Unit for colposcopical evaluation. The main study outcomes were differences in true-positive rates (biopsy confirmed CIN 2, 3) and false-positive rates between the two methods. Results The true-positive (TP) rates were 17.8% versus 13.9% ( P = 0.001) for the combined colposcopy and ODS compared to colposcopy-only, respectively, in women with either an atypical squamous cell (ASC) or low-grade squamous intraepithelial lesion (LGSIL) cytology result. TP rates were 53.6% versus 50% for the combined colposcopy and ODS compared to colposcopy-only, respectively, among women referred for the evaluation of HGSIL. The 28.1% gain in true-positives observed with the use of ODS and colposcopy among women referred for an ASC or LSIL cytology was achieved with only a fractional increase in a number of biopsies obtained per patient (0.21). In the combined colposcopy and ODS among women with ASC or LSIL, the PPV of biopsies indicated by ODS was 24.3% and the PPV of biopsies indicated by colposcopy was 23.3%. All tests indicate that ODS and colposcopy provide benefit compared to colposcopy alone among women with ASC or LGSIL. Conclusions Combining ODS with colposcopy provides a clinically meaningful increase in the detection of CIN 2, 3 in women referred for the evaluation of abnormal cytology results.

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