Main Findings
In this study, we evaluated the efficacy of a real-time and non-invasive optoelectronic cervical screening device (TruScreen) in patients with abnormal TCT results, aiming to broaden the current screening strategies. This is meaningful in nowadays context of COVID-19 post-pandemic. Firstly, we found that TS had significantly higher specificity and PPV either alone or combined with hrHPV than hrHPV alone. Secondly, TS was found to have a higher sensitivity in incomplete cervical TZ type than TZ type I. Particularly, significantly higher specificity and NPV were found in incomplete cervical TZ type. Thirdly, TS demonstrated significantly higher sensitivity in non-menopausal women with TZ type III in detecting CIN1+ and CIN3+. Finally, in ASCUS and LSIL patients with negative TS result, rate of pathology ≤CIN1 were significantly higher than whom with positive TS result.
These findings indicate that TS can play an important role in making up the over-diagnosis and over-referral to colposcopy by hrHPV test. Moreover, TS may overcome the limitations for colposcopists in examining patients with incomplete cervical TZ type and provide a new screening choice for non-menopausal women. For patients with TCT results of ASCUS and LSIL, they can be recommended to do follow-up within 6 months when the TS results are negative.