Ziyao Wang1, YaNan Kang2, FuRong Yu3, Feng-Hui Zhong4, Kangni Huang4, Xuan Zhou5, Yunrong Tang6, Yu Zhang2, Yu-Ligh Liou7,8, Yan Ma3. 1. Department of Ultrasound Medicine, The First Affiliated Hospital of University of South China, Hengyang, Hunan, PR China. 2. Department of Gynecology, Xiangya Hospital, Central South University, Changsha, Hunan, PR China. 3. Department of Obstetrics & Gynecology, The First Affiliated Hospital of University of South China, Hengyang, Hunan, PR China. 4. Department of Obstetrics & Gynecology, Yi Yang Central Hospital, Yiyang, Hunan, PR China. 5. Hunan Cancer Hospital, Changsha, Hunan, PR China. 6. Scientific Information Management & Analysis Department, Hunan Warm Medical Technology Co. LTD, Loudi, Hunan, PR China. 7. Xiangya Medical Laboratory, Central South University, Changsha, Hunan, PR China. 8. The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University, Guangdong, PR China.
Abstract
Aims: To evaluate the efficacy of TruScreen (TS01) for high-risk human papillomavirus (HR-HPV) women compared with other methods in reducing colposcopy referral rates in hospitals. Methods: A single-center, prospective, case-control study was conducted from December 2019 to June 2020. Results: Among 139 (46.2%) HR-HPV-positive patients, 58 were CIN1, 52 were CIN2-3 and 29 had cervical cancer (n = 29). The sensitivity and specificity of detecting CIN2+ by TS01, colposcopy and HPV16/18 testing were 96.3% and 46.4%, 85.2% and 40.5% and 59.3% and 74.1%, respectively. The highest sensitivity was 96.3% at HPV16/18 and TS01 (each positive results), and the highest specificity was 83.6% at HPV16/18 and TS01 (both positive) for CIN2+ compared with the other methods. Conclusion: TS01 is a noninvasive screening method and can be used to diagnose cervical lesions quickly. It is especially suitable as triage tool for HR-HPV-positive women facing SARS-CoV-2 exposure and infection risks in hospital.
Aims: To evaluate the efficacy of TruScreen (TS01) for high-risk human papillomavirus (HR-HPV) women compared with other methods in reducing colposcopy referral rates in hospitals. Methods: A single-center, prospective, case-control study was conducted from December 2019 to June 2020. Results: Among 139 (46.2%) HR-HPV-positive patients, 58 were CIN1, 52 were CIN2-3 and 29 had cervical cancer (n = 29). The sensitivity and specificity of detecting CIN2+ by TS01, colposcopy and HPV16/18 testing were 96.3% and 46.4%, 85.2% and 40.5% and 59.3% and 74.1%, respectively. The highest sensitivity was 96.3% at HPV16/18 and TS01 (each positive results), and the highest specificity was 83.6% at HPV16/18 and TS01 (both positive) for CIN2+ compared with the other methods. Conclusion: TS01 is a noninvasive screening method and can be used to diagnose cervical lesions quickly. It is especially suitable as triage tool for HR-HPV-positive women facing SARS-CoV-2 exposure and infection risks in hospital.