Accuracy of the AI-Based Smart Scope® Test as a Point-of-Care Screening and Triage Tool Compared to Colposcopy: A Pilot Study.

Objectives The primary objective of this study was to compare the screening accuracy of AI assessment with colposcopy. Secondary objectives included comparing the triaging accuracy of AI and colposcopy assessments against histopathology. Methodology This prospective, single-arm screening test assessment study was conducted at the obstetrics and gynecology department of Bharati Vidyapeeth (Deemed to be University) Medical College in Pune, India. The study included sexually active, nonpregnant women aged 25-65 years visiting the OPD for per-speculum examination. Women with a clinically unhealthy cervix detected during the examination were counseled, and those who provided consent were enrolled. Patients with a history of prior cervical cancer treatment or hysterectomy were excluded. A total of 130 women were enrolled. Each participant underwent colposcopy, Smart Scope-AI (SS-AI) assisted visual inspection with acetic acid (VIA), and visual inspection with Lugol's iodine during the same visit. Positive findings from any test led to a biopsy, with samples sent for histopathological analysis. Results Of the 130 women enrolled, 30 were referred for biopsy. Histopathology results were obtained for 18 consenting women. Using colposcopy as the reference standard (N = 130), the accuracy of SS-AI was 76.53%. When compared to histopathology (N = 18) as the gold standard, the accuracy of colposcopy and SS-AI was 63.67% and 83.33%, respectively. The sensitivity and specificity of SS-AI were both 83.33%, while colposcopy had a sensitivity of 83.33% and a specificity of 50%. Likelihood ratios for SS-AI were superior to those of colposcopy. These findings suggest that the SS-AI-assisted test, a digital VIA test, accurately detects positive and negative cervical lesions. Conclusions The SS-AI system demonstrated comparable effectiveness to colposcopy and has the potential to be used as a point-of-care screening and triaging tool in primary healthcare centers lacking colposcopy equipment for triaging purposes.