Comparison of ThinPrep Integrated Imager-Assisted Screening versus Manual Screening of ThinPrep Liquid-Based Cytology Specimens

Abstract

The aim of this study was to find out whether ThinPrep Integrated Imager (Hologic Inc.) screening is noninferior 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 specific-ity, 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.

Diagnostic Management of Oncogenic HPV Cervical Infections: The Field Experience in Wuxi, China

“…And they also reported an 89.7% positive predictive value of ThinPrep cytology test for diagnosis of LSIL and higher ( 10 ). This finding was similar to a recent study with a large sample size on the sensitivity and positive predictive value of ThinPrep cytology test for diagnosis of LSIL and above ( 11 ). However, both studies did not evaluate the accuracy of the ThinPrep cytology test in the diagnosis of cervical cancer and HSIL (a precancerous lesion).…”

BestCyte® primary screening of 500 ThinPrep Pap Test thin-layers: 3 Cytologists’ Interobserver diagnostic concordance with predicate manual microscopy relative to Truth Reference diagnoses defining NILM, ASCUS+, LSIL+, and ASCH+ thresholds for specificity, sensitivity, and equivalency grading

“…Based on 95% CI ranges of specificity values, all 3 cytologists have a Significantly Superior equivalency grading relative to MM ( Table 2 ). Similar studies by Tanaka et al 27 to investigate correlative specificity between MM and TIS analyses on 4011 ThinPrep thin-layers reported a specificity value of 88.87% for MM, and 89.55% for TIS; concluding that TIS was equivalent albeit non-inferior to MM. Data herein reported suggest improved specificity values are possible through BestCyte technology.…”

“…Variations in epithelial cell staining intensity due to shifts in cervical physiology is evidently another variable for consideration in digital system performance assessment. Comparative studies between MM and TIS by Tanaka et al in 2020 27 explored cases deemed ‘unreadable’ by the TIS. Their study concluded potential cytoplasmic over-staining, as may occur due to cervicitis from bacterial vaginosis, interfered with the system’s capacity to differentiate between nucleus and cytoplasm.…”

Cervical cytology screening facilitated by an artificial intelligence microscope: A preliminary study

“…Several AI‐assisted diagnostic systems for cervical cytology screening have been reported 5,29‐36 . The ThinPrep Imaging System (TIS) from Hologic and the FocalPoint Guided Screener (GS) Imaging System from BD Diagnostics are the most 2 famous products with approval from the US Food and Drug Administration.…”

“…Similarly, the FocalPoint GS Imaging System selects 10 FOVs by an image profiler for guided screening in a robotic microscope 32 . Clinical trials of these 2 products have demonstrated that the sensitivity for detecting LSIL, ASC‐H, and/or HSIL in automation‐assisted screening is improved, whereas the specificity is improved or equivalent, in comparison with manual reading 29‐34 . However, there have also been clinical trials showing that the sensitivity declines, albeit with improved productivity 35 .…”