Significant specificity of TruScreen in cervical cytology of ASC and
LSIL women with incomplete cervical transformation zone type during
COVID-19 post-pandemic in China: a prospective study
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.