{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T16:45:31Z","timestamp":1792773931461,"version":"4.5.0"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Whole-slide digital imaging technology paired with artificial intelligence is transforming the practice of cervical cancer screening. We aimed to evaluate the performance of the Hologic Genius Digital Diagnostics System (HGDDS) for detection of neoplasia and to investigate interobserver variability among users who have undergone HGDDS training.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A total of 110 ThinPrep Papanicolaou tests were selected, with original diagnoses that included 47 cases of low-grade squamous intraepithelial lesion or worse (LSIL+); 4 cases of unsatisfactory findings; and 59 cases negative for intraepithelial lesion or malignancy (NILM), including 23 cases with microorganisms. All cases were reviewed by 16 cytologists or cytopathologists using the HGDDS. Interobserver variability and correlation with original diagnoses were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The HGDDS showed greater than 95% sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for LSIL+ disease. The overall misinterpretation rate was 5.5%. In total, 3 cases had poor interpretation (\u22657\/16 misinterpretations), including a high-grade squamous intraepithelial lesion case with 2 adenocarcinoma responses, an LSIL response, and 4 unsatisfactory responses, as well as 2 NILM cases interpreted as unsatisfactory by most participants due to borderline cellularity. Of 23 cases with microorganisms, organisms were not present in the 60-image gallery for 4 cases. Sensitivity was highest for Trichomonas (93.8%) but was low for other microorganisms (58.9%-68.8%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In a large academic cytology laboratory, HGDDS review by trained users demonstrated high concordance with adjudicated diagnoses for detection of LSIL+, supporting its effectiveness for identifying epithelial abnormalities. However, user experience with digital morphology is important. During early implementation, laboratories should monitor discordance and consider temporary dual review, with particular attention to borderline cellularity cases and microorganism detection.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ajcp\/aqag113","type":"journal-article","created":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T16:28:58Z","timestamp":1792772938000},"source":"Crossref","is-referenced-by-count":0,"title":["Interobserver variability in the interpretation of Papanicolaou tests using the Hologic Genius Digital Diagnostics System: detailed analysis of cytology verification in a large academic laboratory"],"prefix":"10.1093","volume":"166","author":[{"given":"Haley","family":"Corbin","sequence":"first","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonee","family":"Matsko","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor","family":"Charity","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Colaizzi","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haley","family":"Brown","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jensen","family":"Bendig","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lakshmi","family":"Harinath","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5965-8294","authenticated-orcid":false,"given":"Beth","family":"Clark","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Elishaev","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1225-8418","authenticated-orcid":false,"given":"Rohit","family":"Bhargava","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liron","family":"Pantanowitz","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7524-3048","authenticated-orcid":false,"given":"Chengquan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Pittsburgh Medical Center , Pittsburgh, PA,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,10,23]]},"reference":[{"key":"2026102312285158300_aqag113-B1","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1016\/j.ygyno.2019.04.004","article-title":"Pathway to the Papanicolaou smear: the development of cervical cytology in twentieth-century America and implications in the present day","volume":"154","author":"Swailes","year":"2019","journal-title":"Gynecol Oncol"},{"key":"2026102312285158300_aqag113-B2","doi-asserted-by":"publisher","first-page":"286","DOI":"10.1159\/000508629","article-title":"Computational cytology: lessons learned from Pap test computer-assisted screening","volume":"65","author":"Lew","year":"2021","journal-title":"Acta Cytol"},{"key":"2026102312285158300_aqag113-B3","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1016\/j.jasc.2024.12.003","article-title":"American Society of Cytopathology\u2019s cytopathology workforce survey in the United States","volume":"14","author":"Satturwar","year":"2025","journal-title":"J Am Soc Cytopathol"},{"key":"2026102312285158300_aqag113-B4","author":"Genius\u00ae Digital Diagnostics System"},{"key":"2026102312285158300_aqag113-B5","doi-asserted-by":"publisher","first-page":"746","DOI":"10.1093\/ajcp\/aqaf099","article-title":"Impact of the Genius Digital Diagnostics System on workflow and accuracy compared with the ThinPrep Imaging System for review of ThinPrep Papanicolaou tests","volume":"164","author":"Murphy","year":"2025","journal-title":"Am J Clin Pathol"},{"key":"2026102312285158300_aqag113-B6","doi-asserted-by":"publisher","first-page":"424","DOI":"10.1002\/cncy.22695","article-title":"Comparison of the Hologic Genius Digital Diagnostics System with the ThinPrep Imaging System\u2014a retrospective assessment","volume":"131","author":"Ikenberg","year":"2023","journal-title":"Cancer Cytopathol"},{"key":"2026102312285158300_aqag113-B7","doi-asserted-by":"publisher","first-page":"513","DOI":"10.1093\/ajcp\/aqaf080","article-title":"Papanicolaou test interpretation utilizing the Hologic Genius Digital Diagnostics System vs manual glass slide review: a retrospective study of 596 cases","volume":"164","author":"Doxtader","year":"2025","journal-title":"Am J Clin Pathol"},{"key":"2026102312285158300_aqag113-B8","doi-asserted-by":"publisher","first-page":"e70022","DOI":"10.1002\/cncy.70022","article-title":"Assessment of the efficacy and accuracy of cervical cytology screening with the Hologic Genius Digital Diagnostics System","volume":"133","author":"Elishaev","year":"2025","journal-title":"Cancer Cytopathol"},{"key":"2026102312285158300_aqag113-B9","doi-asserted-by":"publisher","first-page":"307","DOI":"10.1016\/j.jasc.2023.03.008","article-title":"Changes over time in Papanicolaou cytology test and HPV test in a large women\u2019s academic center laboratory","volume":"12","author":"Jones","year":"2023","journal-title":"J Am Soc Cytopathol"},{"key":"2026102312285158300_aqag113-B10","doi-asserted-by":"publisher","first-page":"434","DOI":"10.1016\/j.jasc.2025.05.003","article-title":"The clinical significance of atypical glandular cells in Papanicolaou tests: changes in diagnostic patterns over 15 years at a single institution","volume":"14","author":"Jones","year":"2025","journal-title":"J Am Soc Cytopathol"},{"key":"2026102312285158300_aqag113-B11","doi-asserted-by":"publisher","first-page":"1221","DOI":"10.5858\/arpa.2015-0446-CP","article-title":"Misinterpretation rates of high-grade squamous intraepithelial lesion in the College of American Pathologists Gynecologic PAP Education and PAP Proficiency Test Program","volume":"140","author":"Zhao","year":"2016","journal-title":"Arch Pathol Lab Med"},{"key":"2026102312285158300_aqag113-B12","doi-asserted-by":"publisher","first-page":"100391","DOI":"10.1016\/j.jpi.2024.100391","article-title":"Validation of AI-assisted ThinPrep\u00ae Pap test screening using the Genius\u2122 Digital Diagnostics System","volume":"15","author":"Cantley","year":"2024","journal-title":"J Pathol Inform"},{"key":"2026102312285158300_aqag113-B13","doi-asserted-by":"publisher","first-page":"e22918","DOI":"10.1002\/cncy.22918","article-title":"Analysis of the sensitivity of high-grade squamous intraepithelial lesion Pap diagnosis and interobserver variability with the Hologic Genius Digital Diagnostics System","volume":"133","author":"Harinath","year":"2025","journal-title":"Cancer Cytopathol"},{"key":"2026102312285158300_aqag113-B14","doi-asserted-by":"publisher","first-page":"378","DOI":"10.1016\/j.jasc.2026.05.004","article-title":"Evaluation of the Hologic Genius Digital Diagnostics System for clinical use in Papanicolaou test interpretation: a validation study of 1748 cases","volume":"15","author":"Underwood","year":"2026","journal-title":"J Am Soc Cytopathol"},{"key":"2026102312285158300_aqag113-B15","doi-asserted-by":"publisher","first-page":"946","DOI":"10.1093\/ajcp\/aqaf126","article-title":"Assessment of microorganism detection in ThinPrep Papanicolaou tests utilizing the Hologic Genius Digital Diagnostics System","volume":"164","author":"Seemaab","year":"2025","journal-title":"Am J Clin Pathol"}],"container-title":["American Journal of Clinical Pathology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ajcp\/article-pdf\/166\/4\/aqag113\/72444273\/aqag113.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajcp\/article-pdf\/166\/4\/aqag113\/72444273\/aqag113.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T16:29:00Z","timestamp":1792772940000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ajcp\/article\/doi\/10.1093\/ajcp\/aqag113\/8994002"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,10,10]]}},"URL":"https:\/\/doi.org\/10.1093\/ajcp\/aqag113","relation":{},"ISSN":["0002-9173","1943-7722"],"issn-type":[{"value":"0002-9173","type":"print"},{"value":"1943-7722","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,10]]},"published":{"date-parts":[[2026,10]]},"article-number":"aqag113"}}