Diagnostic Accuracy of the Siriraj Portable Digital Cervicography Device Versus Standard Colposcopy for Detecting CIN2⁺ Lesions

Abstract

To improve access to colposcopy for women with abnormal cervical cancer screening results, this study evaluated the diagnostic accuracy of the internally developed Siriraj portable digital cervicography device for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and compared its performance with standard colposcopy. Consenting eligible women underwent examination using both the Siriraj portable digital cervicography device and standard colposcopy. Images from each method were independently evaluated by a physician blinded to the other images and histology results. The primary outcome was the diagnostic performance of both methods for detecting CIN2+. Diagnostic accuracy was compared using Cochran's Q test, with a significance threshold of p < 0.05. A total of 450 women participated, with histologically confirmed CIN2+ in 91 cases (20.1%), including 45 women diagnosed with cervical intraepithelial neoplasia grade 3 or worse (CIN3+). Incorporating colposcopic impressions, the modified Reid's colposcopic index, and the modified Swede score, the Siriraj portable digital cervicography device demonstrated a diagnostic accuracy of 81.3% for CIN2+, whereas standard colposcopy ranged from 79.1% to 81.6%. No significant difference in diagnostic accuracy was found among the six evaluative methods (p = 0.558). The Siriraj portable digital cervicography device shows promise as an alternative to standard colposcopy for detecting CIN2+, particularly in low-resource settings. While it enables remote evaluation by trained colposcopists, its diagnostic performance remains dependent on expert image interpretation. Standardizing biopsy protocols and integrating AI-assisted analysis could further enhance its clinical utility. Trial Registration: TCTR20230907004; registered on September 7, 2023; https://thaiclinicaltrials.org.