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.

Objective To assess triage of HPV-positive women by optical coherence tomography (OCT), with or without HPV16/18 genotyping, compare with cytology. Design A prospective cohort study. Setting The Second Xiangya Hospital in China. Population 813 participants with high-risk HPV(hrHPV)-positive and cervical cytology results received OCT before colposcopy between 1 March 2021 and 1 October 2021. Methods OCT examinations were performed on an outpatient basis. Cytological and histological results during follow-up were obtained from the Department of Pathology at the Second Xiangya Hospital. Main outcome measures OCT and cytology results were compared with the pathological results to calculate sensitivity, specificity, and immediate CIN3+ risk. The advantages and disadvantages of OCT and cytology triage of hr-HPV-positive women were compared. Results HPV16/18 genotyping with OCT triage has a specificity of CIN3+ lesions [61.1%; 95% CI, 57.6%-64.6%], CIN2+ [66.0%; 95% CI, 62.4%-69.6%]. HPV16/18 genotyping with cytology triage has a specificity of CIN3+[44.0%; 95% CI, 40.4%-47.6%], CIN2+ [47.0%; 95% CI, 43.2%-50.8%]. The OCT triage has a higher specificity and positive predictive value(PPV) compared to the cytology with a significant difference. The OCT triage has a similar immediate CIN3+ risk compared to the cytology. Conclusion The combination of OCT and HPV triage (both genotyping and non-genotyping) is feasible in terms of immediate CIN2+/CIN3+ risk, and the OCT triage strategy reduces the number of colposcopies and improves the specificity and positive predictive value of the test compared to the cytological triage strategy.