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.
