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.