Objective: The aim of this study was to find out whether ThinPrep Integrated Imager (Hologic Inc.) screening is non-inferior to manual screening in the detection of cervical lesion. Study Design: For a total of 4,011 ThinPrep Pap test specimens stained by ThinPrep staining, manual screening (Manual arm) and ThinPrep Integrated Imager screening (Imager arm) were performed so as not to be screened by the same cytotechnologist, and the sensitivity and specificity in the detection of cervical lesion were compared using McNemar’s test. Results: The sensitivity to detect CIN1 or more squamous cell abnormalities or glandular abnormalities was 91.67% (= 374/408, 95% confidence interval [CI]: 88.44–94.08%) for the Manual arm and 92.40% (= 377/408, 95% CI: 89.28–94.70%) for the Imager arm, and the specificity was 88.87% (= 3,113/3,503, 95% CI: 87.77–89.88%) for the Manual arm and 89.55% (= 3,137/3,503, 95% CI: 88.48–90.54%) for the Imager arm. The differences in sensitivity and in specificity, respectively, were 0.74% (95% CI: −3.14–4.61%, McNemar’s test, p = 0.8041) and 0.69% (95% CI: −0.13–1.50%, McNemar’s test, p = 0.1125). About the equality of sensitivity and specificity between the 2 methods, 95% CIs of the difference between sensitivity and specificity are in the clinical equivalence range of ±5%, so the Imager arm is non-inferior to the Manual arm. Conclusion: The Imager arm was confirmed to have an equivalent and non-inferior capacity in the detection of cervical lesions compared with the Manual arm, suggesting that its practical application in cervical cytology tests is highly possible.
Acta Cytologica

中文翻译：

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ThinPrep集成成像器辅助筛查与ThinPrep液基细胞学样本手动筛查的比较。

目的：本研究旨在确定ThinPrep Integrated Imager（Hologic Inc.）筛查在宫颈病变的检测中是否不逊于人工筛查。研究设计：对于总共4,011份ThinPrep染色的ThinPrep Pap测试样本，进行了手动筛选（Manual arm）和ThinPrep Integrated Imager筛选（Imager arm），以便不由同一位细胞技术人员进行筛选，而且敏感性和特异性在检测宫颈病变中使用McNemar检验进行了比较。结果：手动臂检测CIN1或更多鳞状上皮细胞异常或腺体异常的敏感性为91.67％（= 374/408，95％置信区间[CI]：88.44–94.08％）和92.40％（= 377/408，95％ CI：成像器臂的CI为89.28–94.70％，手动臂的特异性为88.87％（= 3,113 / 3,503，95％CI：87.77–89.88％），成像臂的特异性为89.55％（= 3,137 / 3,503，95％CI： 88.48–90.54％）。敏感性和特异性的差异分别为0.74％（95％CI：-3.14-4.61％，McNemar's test，p = 0.8041）和0.69％（95％CI：-0.13-1.50％，McNemar's test，p= 0.1125）。关于这两种方法之间灵敏度和特异性的相等性，灵敏度和特异性之间的差异的95％CI在临床等效范围内为±5％，因此，成像仪臂不逊于手动臂。结论：与手动臂相比，成像臂在宫颈病变的检测中具有同等且不逊色的能力，这表明其在宫颈细胞学检测中的实际应用是高度可能的。
细胞学学报