Department of Ultrasound Medicine, The First Affiliated Hospital of University of South China, Hengyang, Hunan, PR China.
Department of Gynecology, Xiangya Hospital, Central South University, Changsha, Hunan, PR China.
Future Oncol. 2021 Apr;17(10):1197-1207. doi: 10.2217/fon-2020-0928. Epub 2020 Dec 17.
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. A single-center, prospective, case-control study was conducted from December 2019 to June 2020. 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. 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.
评估 TruScreen（TS01）在降低医院转诊率方面对高危型人乳头瘤病毒（HR-HPV）女性的疗效，与其他方法相比。一项单中心、前瞻性病例对照研究于 2019 年 12 月至 2020 年 6 月进行。在 139 名（46.2%）HR-HPV 阳性患者中，58 名患者为 CIN1，52 名患者为 CIN2-3，29 名患者患有宫颈癌（n=29）。TS01、阴道镜检查和 HPV16/18 检测对 CIN2+的敏感性和特异性分别为 96.3%和 46.4%、85.2%和 40.5%以及 59.3%和 74.1%。HPV16/18 和 TS01（每种阳性结果）的敏感性最高为 96.3%，HPV16/18 和 TS01（均阳性）的特异性最高为 83.6%，用于诊断 CIN2+，与其他方法相比。TS01 是一种非侵入性的筛查方法，可以快速诊断宫颈病变。对于面临 SARS-CoV-2 暴露和感染风险的 HR-HPV 阳性女性，它尤其适合作为阴道镜检查的一种筛查方法。
