【摘要】 目的:在四川省妇科门诊女性中评估TruScreen检查作为子宫颈高级别病变早期诊断技术的准确性。方法:2019年6月至2021年1月，邀请在四川省16家医院妇科就诊拟进行子宫颈阴道镜检查的女性参与研究。纳入标准为近期发现细胞学异常或高危型人乳头瘤病毒(human papillomavirus, HPV)阳性，或有可疑临床症状。研究对象在阴道镜检查前先行TruScreen检查，然后在阴道镜下行活检。组织学诊断为金标准评价TruScreen的准确性。结果:纳入1 319名女性，其中41.8%的女性TruScreen检查阳性。纳入分析的女性中，组织学高级别鳞状上皮内病变(high-grade squamous intraepithelial lesion, HSIL)阳性的检出率为25.5%。TruScreen用于初筛的灵敏度、特异度、AUC分别为87.2%、70.5%和0.789 (0.761,0.816)。TruScreen的灵敏度显著高于细胞学(87.2%vs 73.9%,P<0.001)。45岁以上的女性中，HPV检测与TruScreen的灵敏度接近(85.7%vs 81.9%,P=0.481)。高危型HPV阳性女性中，用TruScreen分流后阳性患者中的HSIL+检出率显著高于用细胞学分流后ASC-US+患者中的HSIL+检出率(55.4%vs 38.4%,P<0.001)。分流TruScreen检测的灵敏度和特异度均显著高于细胞学(89.7%vs 73.0%,67.7%vs 47.8%,P<0.001)。结论:TruScreen检查是一种灵敏度和特异度较高的子宫颈高级别病变早期诊断技术。更多还原

【Abstract】 Objective: To evaluate the accuracy of early diagnosis of high-grade cervical lesions by the TruScreen device in gynecological outpatients in Sichuan Province. Methods: From June 2019 to January 2021, women ready for colposcopy in 16 gynecological clinics in Sichuan Province were invited to participate in the study. Those with cytological abnormalities, positive results in tests for high-risk human papillomavirus(HPV) types, or suspicious clinical symptoms were included in, and were then examined by TruScreen before colposcopy for biopsy. Histological diagnosis was used as the gold standard to evaluate the accuracy of TruScreen. Results: A total of 1,319 women were enrolled, 41.8% of which were HPV-positive by TruScreen. The positive rate of high-grade squamous intraepithelial lesion(HSIL) was 25.5% by histological diagnosis. The sensitivity, specificity and AUC of TruScreen for primary screening were 87.2%, 70.5% and 0.789(0.761-0.816), respectively. The sensitivity of TruScreen was significantly higher than that of cytology(87.2% vs 73.9%, P<0.001). For women over 45 years, the HPV test resembled TruScreen in sensitivity(85.7% vs 81.9%, P=0.481). Among high-risk HPV-positive women, the detection rate of HSIL+ in positive patients triaged by TruScreen was significantly higher than that in ASC-US+-positive patients triaged by cytology(55.4% vs 38.4%, P<0.001). The sensitivity and specificity of triage by TruScreen were significantly higher than those of triage by cytology(89.7% vs 73.0%, 67.7% vs 47.8%, P<0.001). Conclusion: TruScreen examination is an early diagnosis technique for high-grade cervical lesions with high sensitivity and specificity.更多还原