Diagnostic performance of the hologic genius digital diagnostics system for low-grade squamous intraepithelial lesion (LSIL) ThinPrep papanicolaou tests.

Q2 Medicine Journal of the American Society of Cytopathology Pub Date : 2025-01-17 DOI:10.1016/j.jasc.2025.01.003

Lakshmi Harinath, Esther Elishaev, Yuhong Ye, Jonee Matsko, Amy Colaizzi, Stephanie Wharton, Rohit Bhargava, Matthew Hanna, Sarah Harrington, Liron Pantanowitz, Chengquan Zhao

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Abstract

Introduction: Advancements in digital imaging technology for Papanicolaou test slides, combined with artificial intelligence are driving the development and adoption of innovative computer-assisted screening methods for cervical cancer within the cytology community. Our study aimed to assess the performance of the Hologic Genius Digital Diagnostic System (HGDDS) in the interpretation of low-grade squamous intraepithelial lesions (LSIL) in ThinPrep Papanicolaou slides.

Method: As part of a validation study performed with 890 ThinPrep Papanicolaou slides using the HGDDS, a subset of 146 LSIL cases were included in this study. Performance characteristics for the detection of cervical intraepithelial neoplasia (CIN) and interobserver variability among 3 cytopathologists were assessed.

Results: On evaluation of the consensus results of the 3 cytopathologists, of the 146 LSIL Papanicolaou cases, 60.3% were interpreted as LSIL with the HGDDS. The remainder were interpreted as ASCUS (26%), ASC-H (10.3%), HSIL (2.7%), and NILM (0.7%). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for detecting CIN1+ lesions in the ASCUS + category with the HGDDS were 100%, 25%, 97.9%, and 100%, respectively. The sensitivity, specificity, PPV, and NPV for the detection of CIN1+ lesions in the LSIL + category with the HGDDS were 74.7%, 75%, 99.1%, and 7.7%, respectively. Kendall's W coefficient was 0.792, indicating strong agreement among participating pathologists.

Conclusions: Our study demonstrated that ThinPrep Papanicolaou tests with LSIL could be interpreted with strong agreement among pathologists and with good performance indicators when utilizing the HGDDS.

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