Cross-sectional study.
Colposcopy clinics in Central Denmark Region.
Women aged 45 years or older referred for colposcopy because of an abnormal screening test.
All women had a cervical sample collected for cytology and DS testing and underwent large-loop excision of the transformation zone (LLETZ).
Sensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology.
Of 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4-70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty-two women (55.9%) were DS-positive, 29 (55.8%) of whom had CIN2+ detected. Twenty-seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC-US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p = 0.021) and NPV (97.6% versus 86.4%, p = 0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p = 0.001) were lower for DS compared with cytology.
Dual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS-negative women.
方法:横断面研究。
方法:位于丹麦中部地区的阴道镜诊所。
方法:45岁或以上的女性因筛查试验异常而进行阴道镜检查。
方法:所有女性都收集了用于细胞学和DS检测的宫颈样本,并对转化区进行了大环切除(LLETZ)。
方法:灵敏度,将DS对CIN2+检测的特异性和阴性(NPV)和阳性(PPV)预测值与细胞学的预测值进行比较。
结果:在166名符合条件的女性中,93(56.0%)包括在最终分析中。中位年龄为68岁(四分位距[IQR]63.4-70.5岁)。大多数妇女是绝经后(95.7%),并根据人乳头瘤病毒筛查试验阳性(86.0%)转诊。52名女性(55.9%)为DS阳性,29人(55.8%)检测到N2+CI。27名(29.0%)女性患有不确定意义或更差的非典型鳞状细胞(ASC-US+),21名女性(77.8%)检测到N2+。DS具有更高的灵敏度(96.7%对70.0%p=0.021)和NPV(97.6%对86.4%,p=0.018)与细胞学检测CIN2+相比。相比之下,特异性(63.5%对90.5%p<0.001)和PPV(55.8%对77.8%,与细胞学相比,DS的p=0.001)较低。
结论:双重染色可能是指导TZ3患者临床治疗的一个有价值的风险标记。DS的高NPV表明,DS阴性女性可以安全地避免诊断性切除。