Beyond Tradition: Investigating TruScreen's Performance Versus Pap Smear in Cervical Cancer Detection

Objectives: The study aimed to determine whether the real-time optoelectronic device (TruScreen™; TS) could be used as an alternative or adjunct to Pap Smear (Liquid Based Cytology (LBC)) for cervical cancer screening. Method: We conducted a prospective observational study that recruited women who were routinely followed at the gynaecology clinics during the data collection period. All eligible women opportunistically underwent TS and LBC examinations after study enrolment. Women with abnormal findings were referred for colposcopy and cervical biopsy within one month of the abnormal screening results. Results: Overall, 507 women fulfilled the eligibility criteria and were included in this study, of which 30 women (5.9%) had abnormal TS findings and underwent colposcopy. Thirteen women (43.3%) had low-grade lesions, and only one (3.3%) had a high-grade lesion. Regarding biopsy findings, three women had cervical intraepithelial neoplasia (CIN) I, two women had CIN II+, and one had glandular hyperplasia. The TS yielded a sensitivity of 83.3% (95% CI: 35.9-99.6%) and a specificity of 95% (95% CI: 92.7- 96.8%) for the detection of pathologically diagnosed cervical neoplasms, compared to 66.7% (95% CI: 22.3-95.7%) and 98.2% (95%: CI 96.6%-99.2%) of the Pap smear, respectively. The difference between both screening tools was not statistically significant (p=0.91). The sensitivity (100%, 95% CI 15.6–100%) and specificity (95.6%, 95% CI 93.4-97.2%) of TS and Pap smear for CIN II+ lesions were notably high. Conclusion: TS represents a reliable and practical screening tool for cervical neoplasms without the need for cervical samples, laboratory equipment, or trained staff. Our study showed that the tool provided real-time and accurate screening results, making it suitable for screening women at risk of cervical cancer.