Comparison between performance of single-fiber reflectance spectroscopy (SFRS) system and colposcopy: a phase III trial.

Herein, the performance of single-fiber reflectance spectroscopy (SFRS) in detection of cervical pre-cancerous squamous intraepithelial lesions (SIL) was compared with colposcopy. Based on the previous results obtained from 167 samples and finding the contributing parameters in differentiating SILs from non-SILs, a user-friendly interface was developed to detect the SILs using SFRS system. Detection of SILs in 301 patients was performed by both SFRS system and routine colposcopy. In addition to physician-determined sites, four quarters of the cervix were measured by SFRS system and suspicious lesions detected by either method were biopsied. Histopathologic results of the biopsied species were compared to the physician judgments based on colposcopy and the results of SFRS system. SFRS could differentiate between SILs and non-SILs with mean sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 38.3, 60.9, 15.2, and 84.3%, respectively. These values were obtained as 88.3, 10.6, 15.4, and 83.1% for the colposcopy, respectively. Although sensitivity of SFRS in detection of SILs is about twofold less than the colposcopy, it can reduce the number of unnecessary biopsies by a factor of more than 5.5. Therefore, the aid of SFRS system to the physician can reduce the number of unnecessary biopsies. On the other hand, both colposcopy and SFRS methods equally suffer from low detection worth in terms of positive/negative predictive values. In conclusion, using the online, simple and non-invasive SFRS system to choose between several suspicious sites in a patient in the clinic may be recommended.