Evidence map›Paper›PMID 39498535›Full record

ArticleCancer cytopathology2025

Analysis of the sensitivity of high-grade squamous intraepithelial lesion Pap diagnosis and interobserver variability with the Hologic Genius Digital Diagnostics System.

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

Abstract readValidation Study
In one paragraph

Article in Cancer cytopathology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

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8citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Lakshmi HarinathDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-6472-732X
Esther ElishaevDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Yuhong YeDepartment of Pathology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
Jonee MatskoDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Amy ColaizziDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Stephanie WhartonDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Rohit BhargavaDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Liron PantanowitzDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-8182-5503
Chengquan ZhaoDepartment of Pathology, UPMC Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundArtificial intelligence (AI)-based systems are transforming cytopathology practice. The aim of this study was to evaluate the sensitivity of high-grade squamous intraepithelial lesion (HSIL) Papanicolaou (Pap) diagnosis assisted by the Hologic Genius Digital Diagnostics System (GDDS).

methodsA validation study was performed with 890 ThinPrep Pap tests with the GDDS independently. From this set, a subset of 183 cases originally interpreted as HSIL confirmed histologically were included in this study. The sensitivity for detecting HSIL by three cytopathologists was calculated.

resultsMost HSIL cases were classified as atypical glandular cell/atypical squamous cell-high grade not excluded (AGC/ASC-H) and above by all cytopathologists. Of these cases, 11.5% were classified as low-grade squamous intraepithelial lesion (LSIL) by pathologist A (P-A), 6% by pathologist B (P-B), and 5.5% by pathologist C (P-C); 3.8%, 2.7%, and 1.6% of these cases were classified as atypical squamous cell of unknown significance (ASC-US) by P-A, P-B, and P-C, respectively. The sensitivity for detection of cervical intraepithelial neoplasia 2 and above (CIN2+) lesions was 100% if ASC-US and above (ASC-US+) abnormalities were counted among all three pathologists. The sensitivity for detection of CIN2+ lesions was 84.7%, 91.3%, and 92.9% by P-A, P-B, and P-C, respectively, for ASC-H and above abnormalities. The Kendall W coefficient was 0.722, which indicated strong agreement between all pathologists.

conclusionsNew-generation AI-assisted Pap test screening systems such as the GDDS have the potential to transform cytology practice. In this study, the GDDS aided in interpreting HSIL in ThinPrep Pap tests, with good sensitivity and agreement between the pathologists who interacted with this system.

Indexed as

Observer VariationPapanicolaou TestSensitivity and SpecificityUterine Cervical NeoplasmsVaginal SmearsAdultAgedArtificial IntelligenceFemaleHumansMiddle AgedNeoplasm GradingSquamous Intraepithelial LesionsSquamous Intraepithelial Lesions of the CervixUterine Cervical Dysplasiaartificial intelligencedigital pathologyhigh‐grade squamous intraepithelial lesionHologic Genius systemPap (Papanicolaou) tests

Identifiers

PMID39498535
PMCPMC11695705

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.