Assessment of the Real-Time Photoelectric Detection Device (TruScreen) in Screening for Cervical Precancerous Lesions in Middle-Aged Women: An Observational Study.

Objective: To evaluate the efficacy of a real-time photoelectric element (TruScreen) for identifying cervical precancerous lesions in middle-aged women.

Methods: We conducted a retrospective analysis of data collected from 100 women aged 25-55 years who underwent colposcopy at Beijing Obstetrics and Gynecology Hospital between June and July 2018. We obtained the results of the ThinPrep cytologic test/HPV tests and TruScreen tests conducted before colposcopy as well as the histopathological results from postoperative multi-site biopsies. Patients were divided into two groups based on histopathological findings: CIN II or higher, and CIN I. We analyzed the diagnostic efficacy of different testing methods, alone and in combination, for cervical precancerous lesions.

Results: TruScreen demonstrated good specificity (74.4%) and sensitivity (86.4%) for detecting CIN II or higher lesions, superior to those of TCT alone (sensitivity, 81.8%; specificity, 38.2%) and HPV testing alone (sensitivity, 81.8%; specificity, 28.2%). When different testing methods were combined, the sensitivity of TCT+HR-HPV, TruScreen+HR-HPV, and TruScreen+HR-HPV+TCT reached 100%, while the highest specificity was observed with TruScreen+HR-HPV (25.6%).

Conclusion: TruScreen showed high accuracy and specificity for screening cervical precancerous lesions in middle-aged women. The sensitivity and specificity can be improved when combined with HR-HPV test and TCT test. TruScreen has low sampling requirements for clinicians and does not require laboratory doctors or pathologists equipped with PCR equipment to verify. Given its minimal dependence on medical conditions, TruScreen can be considered a potential supplementary screening tool for cervical precancerous lesions.