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.