Author:
Tanaka Kyoko,Aoki Daisuke,Tozawa-Ono Akiko,Suzuki Nao,Takamatsu Kiyoshi,Nakamura Masaru,Tsunoda Hajime,Seino Shigeo,Kobayashi Noriko,Shirayama Takefumi,Takahashi Fumiaki
Abstract
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.
Subject
General Medicine,Histology,Pathology and Forensic Medicine
Reference17 articles.
1. Birdson GG. Automated screening of cervical cytology specimens. Hum Pathol. 1996;27(5):468–81.
2. Wilbur DC, Parker EM, Foti JA. Location-guided screening of liquid-based cervical cytology specimens: a potential improvement in accuracy and productivity is demonstrated in a preclinical feasibility trial. Am J Clin Pathol. 2002;118(3):399–407.
3. Biscotti CV, Dawson AE, Dziura B, Galup L, Darragh T, Rahemtulla A, et al. Assisted primary screening using the automated ThinPrep Imaging System. Am J Clin Pathol. 2005;123(2):281–7.
4. Dziura B, Quinn S, Richard K. Performance of an imaging system vs. manual screening in the detection of squamous intraepithelial lesions of the uterine cervix. Acta Cytol. 2006;50(3):309–11.
5. Davey E, d’Assuncao J, Irwig L, Macaskill P, Chan SF, Richards A, et al. Accuracy of reading liquid based cytology slides using the ThinPrep Imager compared with conventional cytology: prospective study. BMJ. 2007;335(7609):31–8.
Cited by
4 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献