Abstract

Colposcopy-guided biopsy is the standard method to diagnose cervical pre-invasive lesions. However, standard colposcopes are expensive, require lot of space and depend on electricity for its use. A mobile version of colposcope (Gynocular) has been recently introduced which overcomes such issues. We conducted this study to evaluate the diagnostic accuracy of Gynocular for cervical intraepithelial lesions. This cross sectional study was conducted over one year in a tertiary care referral centre in North India. Total 222 women with abnormal Pap smear were included. To avoid observer bias, Gynocular and standard colposcope examinations were performed by two different observers at different places. Patients with swede score 5 or above by standard colposcopy were subjected to biopsy. Kappa statistics was applied for analysing correlation of swede score by the two methods and diagnostic efficacies were calculated with histopathology as gold standard. 100 women had swede score of 5 or above with Gynocular and 86 of these had high swede score on colposcopy also. Histopathology was available for these 86 women. Both colposcopy methods were in strong agreement (Kappa = 0.795; p < 0.001) for swede scoring. HPE showed CIN 1 in 13.95%, CIN 2 in 4.65%, CIN3 in 6.98% and invasive cancer in 13.95% women. The HPE based sensitivity, specificity, negative and positive predictive values for Gynocular(100%, 61%, 100% and 22% respectively) were comparable with Standard colposcope. Gynocular has comparable diagnostic accuracy with standard colposcope in diagnosing CIN.

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