Abstract
Objective: To evaluate the efficacy of TruScreen (TS) detecting
cervical intraepithelial neoplasia (CIN) in cytology of atypical
squamous cells (ASC) and low-grade squamous intraepithelial lesion
(LSIL) women during COVID-19 post-pandemic.
Design: Prospective, single-center study.
Setting: Changsha, China.
Population: ASC and LSIL women from December 2020 to May 2021.
Methods: Participants underwent TS, colposcopy examination and
biopsy in turn. Diagnostic value of TS, high-risk human papillomavirus
(hrHPV) and TS combined with hrHPV were compared. Differences of TS
regarding cervical transformation zone (TZ) type and menopause,
correlations between TS and p16, Ki-67 were assessed.
Main outcome measures: Sensitivity, specificity, positive
predictive value (PPV), negative predictive value (NPV) and area under
curve (AUC) for diagnostic value. Spearman coefficient for correlation.
Results: A total of 483 patients were enrolled. Specificity of
TS detecting CIN1+, CIN2+, CIN3+ were 77.1% (95% CI, 70.4%-82.7%),
66.7% (95% CI, 61.5%-71.5%), 62.7% (95% CI, 57.8%-67.4%) and all
were significantly higher than hrHPV test (P<0.001). TS had a
high sensitivity (68.0% vs 52.0%, P>0.05) and
significantly higher specificity (70.0% vs 48.5%, P<0.05)
and NPV (89.6% vs 73.3%, P<0.05) in women with incomplete
cervical TZ type (II and III) than TZ type I in detection of CIN2+.
Conclusion: TS is an effective triage screening method for
cervical cytology of ASC and LSIL women during COVID-19 post-pandemic,
especially for incomplete cervical TZ type women.
Funding: Supported by National Natural Science Foundation
Project of China (81771546) and Hunan Science and Technology Innovation
Project (2020SK53404).
Keywords: TruScreen; Cervical cancer screening; Cervical
transformation zone; CIN; COVID-19.