Evidence map›Paper›PMID 41476572›Full record

ArticleJournal of pathology informatics2026

Technical considerations during validation of the Genius® Digital Diagnostic System.

Lakshmi Harinath, Sarah Harrington, Jonee Matsko, Amy Colaizzi, Esther Elishaev, Samer Khader, Rohit Bhargava, Chengquan Zhao, Liron Pantanowitz

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pathology informatics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Lakshmi HarinathDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.
Sarah HarringtonScientific Affairs, Hologic INC, Marlboro, Boston, MA, USA.
Jonee MatskoDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.
Amy ColaizziDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.
Esther ElishaevDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.
Samer KhaderDepartment of Pathology, University of Pittsburgh, UPMC Shadyside Hospital, Pittsburgh, PA, USA.
Rohit BhargavaDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.
Chengquan ZhaoDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.
Liron PantanowitzDepartment of Pathology, University of Pittsburgh, UPMC Magee Womens Hospital, Pittsburgh, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The aim of this study was to document technical errors encountered during validation of the Genius Digital Diagnostics System (GDDS). Materials and methods: A total of 909 cases of archived ThinPrep Pap slides with follow-up biopsies were retrieved. Slides were cleaned, relabeled, and scanned with GDDS. Digital imager errors, including slide events and imager errors, were documented and evaluated. Results: Of the 909 slides scanned, 21 (2.3 %) demonstrated slide events. For 5 cases, the slides had cell focus errors, 12 failed due to quality control (QC) errors, 2 had barcode issues, 1 showed an oversaturated frame, and 1 presented a problem because it was a duplicate. Some errors could be corrected, of which 8 cases with various diagnostic cytology interpretations were successfully rescanned. There were 13 (1.4%) cases that could not be scanned and thus were excluded from the study, predominantly because of focus QC errors due to scratched coverslips from long-term storage. There were 43 imager errors including failure of motor movement, cancellation of slide handling action, and failure to pick slides from the carrier station for which the scanning process had to be paused. Imager errors were solved by rebooting the system, correcting the positioning of the slide on the system, and technical help provided by the vendor. Conclusion: Minor errors are to be expected when digitizing large volume of Pap slides. Total number of rescanned cases to address such technical problems were low in number and did not compromise the interpretation of Pap test slides using GDDS.

Indexed as

AI assisted cervical cytologyHologic Genius SystemTechnical considerationsTechnical issues with AI integrationValidation study

Identifiers

PMID41476572
PMCPMC12753272

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.