Abstract
OBJECTIVES: This study aimed to evaluate the potential of real-time optoelectronic device (TruScreen™; TS; TruScreen Group Limited, New Zealand) as an alternative or adjunct to Pap Smear (Liquid Based Cytology (LBC)) for cervical cancer screening. METHOD: We conducted a prospective observational pilot study involving 507 women who were routinely followed at gynecology clinics. All participants underwent TS and LBC examinations after study enrolment. Those with abnormal findings were referred for colposcopy and cervical biopsy within one month. 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) 1, two women had 'CIN2 + , 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 cervical abnormality, 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 'CIN2 + lesions were notably high. CONCLUSION: TS demonstrated potential as a screening tool for cervical neoplasms in this preliminary study. The tool did not require cervical samples, laboratory equipment, or highly trained personnel. While our findings suggest the potential for real-time and accurate screening, further research with a larger sample size is necessary to confirm its reliability and practicality.